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Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Bazedoxifene Acetate

Placebo

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, Postmenopause

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Must be at least 2 years postmenopausal Osteoporotic subjects without vertebral fracture who meet BMD criteria, or Osteoporotic subjects with vertebral fracture Exclusion Criteria: Diseases that may affect bone metabolism Vasomotor symptoms requiring treatment Known history or suspected cancer of the breast Active or past history of venous thromboembolic events

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With New Vertebral Fractures Through Month 36

New vertebral fracture: decrease in anterior, mid, or posterior vertebral (vt) height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.

Percentage of Participants With New Vertebral Fractures Through Month 60

New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.

Percentage of Participants With New Vertebral Fractures Through Month 84

Secondary Outcome Measures

Incidence of Breast Cancer Through Month 36

Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).

Incidence of Breast Cancer Through Month 60

Incidence of Breast Cancer Through Month 84

Percentage of Participants With New Clinical Vertebral Fractures Through Month 36

A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.

Percentage of Participants With New Clinical Vertebral Fractures Through Month 60

Percentage of Participants With New Clinical Vertebral Fractures Through Month 84

Number of Participants With Worsening Vertebral Fractures Through Month 36

A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.

Number of Participants With Worsening Vertebral Fractures Through Month 60

Number of Participants With Worsening Vertebral Fractures Through Month 84

Percentage of Participants With Non-vertebral Fractures Through Month 36

Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.

Percentage of Participants With Non-vertebral Fractures Through Month 60

Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.

Percentage of Participants With Non-vertebral Fractures Through Month 84

Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.

Change From Baseline in Height at Month 36

Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).

Change From Baseline in Height at Month 60

Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).

Change From Baseline in Height at Month 84

Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).

Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36

BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.

Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60

Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84

Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12

Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.

Percent Change From Baseline in Osteocalcin at Months 36 and 60

Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.

Percent Change From Baseline in Osteocalcin at Months 72 and 84

Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.

Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12

C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.

Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60

C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.

Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84

C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.

Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36

Lipid parameters evaluated included total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), triglyceride (TG), high-density lipoprotein fraction 2 (HDL2) and high-density lipoprotein fraction 3 (HDL3).

Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP).

Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP

Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Wall Thickness (WTh), Osteoid Thickness (OTh), Trabecular Thickness (TbTh), Trabecular Separation (TbSp) and Cortical thickness (CTh). Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.

Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: WTh, OTh, TbTh, TbSp and CTh. Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.

Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG]

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner's staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.

Bone Histomorphometric Indices at Month 60: TSG

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner's staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.

Bone Histomorphometric Indices at Month 36: TtAr

Bone Histomorphometric Indices at Month 60: TtAr

Bone Histomorphometric Indices at Month 36: BFP, RP and RmP

Bone Histomorphometric Indices at Month 60: BFP, RP and RmP

Bone Histomorphometric Indices at Month 36: SuD

Bone Histomorphometric Indices at Month 60: SuD

Bone Histomorphometric Indices at Month 36: BFRTS

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).

Bone Histomorphometric Indices at Month 60: BFRTS

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).

Bone Histomorphometric Indices at Month 36: ACF

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).

Bone Histomorphometric Indices at Month 60: ACF

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).

Bone Histomorphometric Indices at Month 36: Mlt

Bone Histomorphometric Indices at Month 60: Mlt

Bone Histomorphometric Indices at Month 36: MAR

Bone Histomorphometric Indices at Month 60: MAR

Bone Histomorphometric Indices at Month 36: TbN

Bone Histomorphometric Indices at Month 60: TbN

Bone Histomorphometric Indices at Month 36: BFRBV

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).

Bone Histomorphometric Indices at Month 60: BFRBV

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).

Women's Health Questionnaire (WHQ)

WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction. Baseline values at different time points were considered only for the participants who were evaluable at those time points.

Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36

WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction.Baseline values at different time points were considered only for the participants who were evaluable at those time points.

European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO)

QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points.

Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36

Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.

Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36

Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.

Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36

Full Information

NCT ID

NCT00205777

First Posted

September 16, 2005

Last Updated

February 28, 2013

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00205777

Brief Title

Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

Official Title

Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

December 2001 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

Osteoporosis, Postmenopause

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

7609 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Bazedoxifene Acetate

Intervention Description

BZA 20mg, daily, oral

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo, daily, oral

Primary Outcome Measure Information:

Title

Percentage of Participants With New Vertebral Fractures Through Month 36

Description

Time Frame

Baseline through Month 36

Title

Percentage of Participants With New Vertebral Fractures Through Month 60

Description

Time Frame

Baseline through Month 60

Title

Percentage of Participants With New Vertebral Fractures Through Month 84

Description

Time Frame

Baseline through Month 84

Secondary Outcome Measure Information:

Title

Incidence of Breast Cancer Through Month 36

Description

Time Frame

Baseline through Month 36

Title

Incidence of Breast Cancer Through Month 60

Description

Time Frame

Baseline through Month 60

Title

Incidence of Breast Cancer Through Month 84

Description

Time Frame

Baseline through Month 84

Title

Percentage of Participants With New Clinical Vertebral Fractures Through Month 36

Description

Time Frame

Baseline through Month 36

Title

Percentage of Participants With New Clinical Vertebral Fractures Through Month 60

Description

Time Frame

Baseline through Month 60

Title

Percentage of Participants With New Clinical Vertebral Fractures Through Month 84

Description

Time Frame

Baseline through Month 84

Title

Number of Participants With Worsening Vertebral Fractures Through Month 36

Description

Time Frame

Baseline through Month 36

Title

Number of Participants With Worsening Vertebral Fractures Through Month 60

Description

Time Frame

Baseline through Month 60

Title

Number of Participants With Worsening Vertebral Fractures Through Month 84

Description

Time Frame

Baseline through Month 84

Title

Percentage of Participants With Non-vertebral Fractures Through Month 36

Description

Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.

Time Frame

Baseline through Month 36

Title

Percentage of Participants With Non-vertebral Fractures Through Month 60

Description

Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.

Time Frame

Baseline through Month 60

Title

Percentage of Participants With Non-vertebral Fractures Through Month 84

Description

Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.

Time Frame

Baseline through Month 84

Title

Change From Baseline in Height at Month 36

Description

Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).

Time Frame

Baseline, Month 36

Title

Change From Baseline in Height at Month 60

Description

Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).

Time Frame

Baseline, Month 60

Title

Change From Baseline in Height at Month 84

Description

Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).

Time Frame

Baseline, Month 84

Title

Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36

Description

Time Frame

Baseline, Months 6, 12, 18, 24, 36

Title

Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60

Description

Time Frame

Baseline, Month 48, 60

Title

Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84

Description

Time Frame

Baseline, Month 72, 84

Title

Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12

Description

Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.

Time Frame

Baseline, Months 3, 6, 12

Title

Percent Change From Baseline in Osteocalcin at Months 36 and 60

Description

Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.

Time Frame

Baseline, Months 36, 60

Title

Percent Change From Baseline in Osteocalcin at Months 72 and 84

Description

Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.

Time Frame

Baseline, Months 72, 84

Title

Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12

Description

C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.

Time Frame

Baseline, Months 3, 6, 12

Title

Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60

Description

C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.

Time Frame

Baseline, Months 36, 60

Title

Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84

Description

C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.

Time Frame

Baseline, Months 72, 84

Title

Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36

Description

Time Frame

Baseline, Months 6, 12, 24, 36

Title

Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP

Description

Time Frame

Month 36

Title

Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP

Description

Time Frame

Month 60

Title

Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh

Description

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Wall Thickness (WTh), Osteoid Thickness (OTh), Trabecular Thickness (TbTh), Trabecular Separation (TbSp) and Cortical thickness (CTh). Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.

Time Frame

Month 36

Title

Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh

Description

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: WTh, OTh, TbTh, TbSp and CTh. Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.

Time Frame

Month 60

Title

Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG]

Description

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner's staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.

Time Frame

Month 36

Title

Bone Histomorphometric Indices at Month 60: TSG

Description

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner's staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.

Time Frame

Month 60

Title

Bone Histomorphometric Indices at Month 36: TtAr

Description

Time Frame

Month 36

Title

Bone Histomorphometric Indices at Month 60: TtAr

Description

Time Frame

Month 60

Title

Bone Histomorphometric Indices at Month 36: BFP, RP and RmP

Description

Time Frame

Month 36

Title

Bone Histomorphometric Indices at Month 60: BFP, RP and RmP

Description

Time Frame

Month 60

Title

Bone Histomorphometric Indices at Month 36: SuD

Description

Time Frame

Month 36

Title

Bone Histomorphometric Indices at Month 60: SuD

Description

Time Frame

Month 60

Title

Bone Histomorphometric Indices at Month 36: BFRTS

Description

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).

Time Frame

Month 36

Title

Bone Histomorphometric Indices at Month 60: BFRTS

Description

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).

Time Frame

Month 60

Title

Bone Histomorphometric Indices at Month 36: ACF

Description

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).

Time Frame

Month 36

Title

Bone Histomorphometric Indices at Month 60: ACF

Description

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).

Time Frame

Month 60

Title

Bone Histomorphometric Indices at Month 36: Mlt

Description

Time Frame

Month 36

Title

Bone Histomorphometric Indices at Month 60: Mlt

Description

Time Frame

Month 60

Title

Bone Histomorphometric Indices at Month 36: MAR

Description

Time Frame

Month 36

Title

Bone Histomorphometric Indices at Month 60: MAR

Description

Time Frame

Month 60

Title

Bone Histomorphometric Indices at Month 36: TbN

Description

Time Frame

Month 36

Title

Bone Histomorphometric Indices at Month 60: TbN

Description

Time Frame

Month 60

Title

Bone Histomorphometric Indices at Month 36: BFRBV

Description

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).

Time Frame

Month 36

Title

Bone Histomorphometric Indices at Month 60: BFRBV

Description

Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).

Time Frame

Month 60

Title

Women's Health Questionnaire (WHQ)

Description

Time Frame

Baseline

Title

Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36

Description

WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction.Baseline values at different time points were considered only for the participants who were evaluable at those time points.

Time Frame

Baseline, Months 12, 24, 36

Title

European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO)

Description

Time Frame

Baseline

Title

Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36

Description

Time Frame

Baseline, Months 12, 24, 36

Title

Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)

Description

Time Frame

Baseline

Title

Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36

Description

Time Frame

Baseline, Months 12, 24, 36

Title

Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score

Description

Time Frame

Baseline

Title

Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36

Description

Time Frame

Baseline, Months 12, 24, 36

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Pfizer Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35249-7201

Country

United States

Facility Name

Pfizer Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294-3708

Country

United States

Facility Name

Pfizer Investigational Site

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Pfizer Investigational Site

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Pfizer Investigational Site

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85306

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85007

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013-3903

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85015

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85020

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85027

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85050

Country

United States

Facility Name

Pfizer Investigational Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85251

Country

United States

Facility Name

Pfizer Investigational Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85254

Country

United States

Facility Name

Pfizer Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Pfizer Investigational Site

City

Berkeley

State/Province

California

ZIP/Postal Code

94705

Country

United States

Facility Name

Pfizer Investigational Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Pfizer Investigational Site

City

Fresno

State/Province

California

ZIP/Postal Code

93710

Country

United States

Facility Name

Pfizer Investigational Site

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Pfizer Investigational Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Pfizer Investigational Site

City

Oakland

State/Province

California

ZIP/Postal Code

94612

Country

United States

Facility Name

Pfizer Investigational Site

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

Pfizer Investigational Site

City

Palm Springs

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

Pfizer Investigational Site

City

Palm Springs

State/Province

California

ZIP/Postal Code

92262

Country

United States

Facility Name

Pfizer Investigational Site

City

Palm Springs

State/Province

California

ZIP/Postal Code

92263

Country

United States

Facility Name

Pfizer Investigational Site

City

Rancho Mirage

State/Province

California

ZIP/Postal Code

92270

Country

United States

Facility Name

Pfizer Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Facility Name

Pfizer Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Pfizer Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95825

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

Pfizer Investigational Site

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Pfizer Investigational Site

City

Whittier

State/Province

California

ZIP/Postal Code

90602

Country

United States

Facility Name

Pfizer Investigational Site

City

Lakewood

State/Province

Colorado

ZIP/Postal Code

80227

Country

United States

Facility Name

Pfizer Investigational Site

City

Longmont

State/Province

Colorado

ZIP/Postal Code

80501

Country

United States

Facility Name

Pfizer Investigational Site

City

Wheat Ridge

State/Province

Colorado

ZIP/Postal Code

80033

Country

United States

Facility Name

Pfizer Investigational Site

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

06606

Country

United States

Facility Name

Pfizer Investigational Site

City

Hamden

State/Province

Connecticut

ZIP/Postal Code

06518

Country

United States

Facility Name

Pfizer Investigational Site

City

Madison

State/Province

Connecticut

ZIP/Postal Code

06443

Country

United States

Facility Name

Pfizer Investigational Site

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

Facility Name

Pfizer Investigational Site

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Facility Name

Pfizer Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20006

Country

United States

Facility Name

Pfizer Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007-2197

Country

United States

Facility Name

Pfizer Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Pfizer Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

Pfizer Investigational Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Pfizer Investigational Site

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33432

Country

United States

Facility Name

Pfizer Investigational Site

City

Cape Coral

State/Province

Florida

ZIP/Postal Code

33990

Country

United States

Facility Name

Pfizer Investigational Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33761

Country

United States

Facility Name

Pfizer Investigational Site

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32114

Country

United States

Facility Name

Pfizer Investigational Site

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Pfizer Investigational Site

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33484

Country

United States

Facility Name

Pfizer Investigational Site

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33919

Country

United States

Facility Name

Pfizer Investigational Site

City

Ft. Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

Pfizer Investigational Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32601

Country

United States

Facility Name

Pfizer Investigational Site

City

Holiday

State/Province

Florida

ZIP/Postal Code

34690

Country

United States

Facility Name

Pfizer Investigational Site

City

Lake Worth

State/Province

Florida

ZIP/Postal Code

33461

Country

United States

Facility Name

Pfizer Investigational Site

City

Largo

State/Province

Florida

ZIP/Postal Code

33773

Country

United States

Facility Name

Pfizer Investigational Site

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Pfizer Investigational Site

City

Palm Beach Gardens

State/Province

Florida

ZIP/Postal Code

33410

Country

United States

Facility Name

Pfizer Investigational Site

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Pfizer Investigational Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33027

Country

United States

Facility Name

Pfizer Investigational Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33029

Country

United States

Facility Name

Pfizer Investigational Site

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Pfizer Investigational Site

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

Pfizer Investigational Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34231

Country

United States

Facility Name

Pfizer Investigational Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Pfizer Investigational Site

City

St Petersburg

State/Province

Florida

ZIP/Postal Code

33710

Country

United States

Facility Name

Pfizer Investigational Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Pfizer Investigational Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Pfizer Investigational Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

Facility Name

Pfizer Investigational Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33417

Country

United States

Facility Name

Pfizer Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

Facility Name

Pfizer Investigational Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Pfizer Investigational Site

City

Riverdale

State/Province

Georgia

ZIP/Postal Code

30274

Country

United States

Facility Name

Pfizer Investigational Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

Pfizer Investigational Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83704

Country

United States

Facility Name

Pfizer Investigational Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83712

Country

United States

Facility Name

Pfizer Investigational Site

City

Cadwell

State/Province

Idaho

ZIP/Postal Code

83605

Country

United States

Facility Name

Pfizer Investigational Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Pfizer Investigational Site

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Pfizer Investigational Site

City

Champaign

State/Province

Illinois

ZIP/Postal Code

61820

Country

United States

Facility Name

Pfizer Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Pfizer Investigational Site

City

Libertyville

State/Province

Illinois

ZIP/Postal Code

60048

Country

United States

Facility Name

Pfizer Investigational Site

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61614

Country

United States

Facility Name

Pfizer Investigational Site

City

Avon

State/Province

Indiana

ZIP/Postal Code

46123

Country

United States

Facility Name

Pfizer Investigational Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47712

Country

United States

Facility Name

Pfizer Investigational Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Pfizer Investigational Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47750

Country

United States

Facility Name

Pfizer Investigational Site

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160-7136

Country

United States

Facility Name

Pfizer Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Pfizer Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40291

Country

United States

Facility Name

Pfizer Investigational Site

City

Lousiville

State/Province

Kentucky

ZIP/Postal Code

40291

Country

United States

Facility Name

Pfizer Investigational Site

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Pfizer Investigational Site

City

Bangor

State/Province

Maine

ZIP/Postal Code

4401

Country

United States

Facility Name

Pfizer Investigational Site

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

Pfizer Investigational Site

City

Silver Spring

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Pfizer Investigational Site

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Pfizer Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Pfizer Investigational Site

City

Brookline

State/Province

Massachusetts

ZIP/Postal Code

02445

Country

United States

Facility Name

Pfizer Investigational Site

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02720

Country

United States

Facility Name

Pfizer Investigational Site

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02721

Country

United States

Facility Name

Pfizer Investigational Site

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Facility Name

Pfizer Investigational Site

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49546

Country

United States

Facility Name

Pfizer Investigational Site

City

Kalamazaoo

State/Province

Michigan

ZIP/Postal Code

49048

Country

United States

Facility Name

Pfizer Investigational Site

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49048

Country

United States

Facility Name

Pfizer Investigational Site

City

Brooklyn Center

State/Province

Minnesota

ZIP/Postal Code

55430

Country

United States

Facility Name

Pfizer Investigational Site

City

Robbinsdale

State/Province

Minnesota

ZIP/Postal Code

55422

Country

United States

Facility Name

Pfizer Investigational Site

City

Shoreview

State/Province

Minnesota

ZIP/Postal Code

55126

Country

United States

Facility Name

Pfizer Investigational Site

City

Flowood

State/Province

Mississippi

ZIP/Postal Code

39232

Country

United States

Facility Name

Pfizer Investigational Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

Pfizer Investigational Site

City

Jefferson City

State/Province

Missouri

ZIP/Postal Code

65109

Country

United States

Facility Name

Pfizer Investigational Site

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Pfizer Investigational Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Pfizer Investigational Site

City

Billings

State/Province

Montana

ZIP/Postal Code

59101

Country

United States

Facility Name

Pfizer Investigational Site

City

Bozeman

State/Province

Montana

ZIP/Postal Code

59715

Country

United States

Facility Name

Pfizer Investigational Site

City

Missoula

State/Province

Montana

ZIP/Postal Code

59801

Country

United States

Facility Name

Pfizer Investigational Site

City

Missoula

State/Province

Montana

ZIP/Postal Code

59802

Country

United States

Facility Name

Pfizer Investigational Site

City

Missoula

State/Province

Montana

ZIP/Postal Code

59804

Country

United States

Facility Name

Pfizer Investigational Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68510

Country

United States

Facility Name

Pfizer Investigational Site

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89014

Country

United States

Facility Name

Pfizer Investigational Site

City

North Las Vegas

State/Province

Nevada

ZIP/Postal Code

89030

Country

United States

Facility Name

Pfizer Investigational Site

City

Reno

State/Province

Nevada

ZIP/Postal Code

89502-1196

Country

United States

Facility Name

Pfizer Investigational Site

City

Reno

State/Province

Nevada

ZIP/Postal Code

89503

Country

United States

Facility Name

Pfizer Investigational Site

City

Manchester Twp

State/Province

New Jersey

ZIP/Postal Code

08759

Country

United States

Facility Name

Pfizer Investigational Site

City

Ocean

State/Province

New Jersey

ZIP/Postal Code

07712

Country

United States

Facility Name

Pfizer Investigational Site

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08542

Country

United States

Facility Name

Pfizer Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Pfizer Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

Pfizer Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

Pfizer Investigational Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Pfizer Investigational Site

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Pfizer Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

Pfizer Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

Facility Name

Pfizer Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Pfizer Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Pfizer Investigational Site

City

Bismarck

State/Province

North Dakota

ZIP/Postal Code

58501

Country

United States

Facility Name

Pfizer Investigational Site

City

Bismark

State/Province

North Dakota

ZIP/Postal Code

58501

Country

United States

Facility Name

Pfizer Investigational Site

City

Bismark

State/Province

North Dakota

ZIP/Postal Code

58503

Country

United States

Facility Name

Pfizer Investigational Site

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

Pfizer Investigational Site

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58104

Country

United States

Facility Name

Pfizer Investigational Site

City

Jamestown

State/Province

North Dakota

ZIP/Postal Code

58401

Country

United States

Facility Name

Pfizer Investigational Site

City

Minot

State/Province

North Dakota

ZIP/Postal Code

58701

Country

United States

Facility Name

Pfizer Investigational Site

City

Minot

State/Province

North Dakota

ZIP/Postal Code

58702

Country

United States

Facility Name

Pfizer Investigational Site

City

Oakes

State/Province

North Dakota

ZIP/Postal Code

58574

Country

United States

Facility Name

Pfizer Investigational Site

City

Akron

State/Province

Ohio

ZIP/Postal Code

44312-1647

Country

United States

Facility Name

Pfizer Investigational Site

City

Akron

State/Province

Ohio

ZIP/Postal Code

44313

Country

United States

Facility Name

Pfizer Investigational Site

City

Centerville

State/Province

Ohio

ZIP/Postal Code

45459

Country

United States

Facility Name

Pfizer Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45236

Country

United States

Facility Name

Pfizer Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45249

Country

United States

Facility Name

Pfizer Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Pfizer Investigational Site

City

Kettering

State/Province

Ohio

ZIP/Postal Code

45459

Country

United States

Facility Name

Pfizer Investigational Site

City

Lyndhurst

State/Province

Ohio

ZIP/Postal Code

44124

Country

United States

Facility Name

Pfizer Investigational Site

City

Mayfield Village

State/Province

Ohio

ZIP/Postal Code

44143

Country

United States

Facility Name

Pfizer Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112-4481

Country

United States

Facility Name

Pfizer Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73142

Country

United States

Facility Name

Pfizer Investigational Site

City

Oklahoma

State/Province

Oklahoma

ZIP/Postal Code

73102

Country

United States

Facility Name

Pfizer Investigational Site

City

Oklahoma

State/Province

Oklahoma

ZIP/Postal Code

73120

Country

United States

Facility Name

Pfizer Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74135

Country

United States

Facility Name

Pfizer Investigational Site

City

Yukon

State/Province

Oklahoma

ZIP/Postal Code

73099

Country

United States

Facility Name

Pfizer Investigational Site

City

Altoona

State/Province

Pennsylvania

ZIP/Postal Code

16602

Country

United States

Facility Name

Pfizer Investigational Site

City

Camp Hill

State/Province

Pennsylvania

ZIP/Postal Code

17011

Country

United States

Facility Name

Pfizer Investigational Site

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Pfizer Investigational Site

City

Johnstown

State/Province

Pennsylvania

ZIP/Postal Code

15904

Country

United States

Facility Name

Pfizer Investigational Site

City

Langhome

State/Province

Pennsylvania

ZIP/Postal Code

19047

Country

United States

Facility Name

Pfizer Investigational Site

City

Lemoyne

State/Province

Pennsylvania

ZIP/Postal Code

17043

Country

United States

Facility Name

Pfizer Investigational Site

City

Newtown

State/Province

Pennsylvania

ZIP/Postal Code

18940

Country

United States

Facility Name

Pfizer Investigational Site

City

Sellersville

State/Province

Pennsylvania

ZIP/Postal Code

18960

Country

United States

Facility Name

Pfizer Investigational Site

City

West Reading

State/Province

Pennsylvania

ZIP/Postal Code

19611

Country

United States

Facility Name

Pfizer Investigational Site

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Pfizer Investigational Site

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Pfizer Investigational Site

City

Belton

State/Province

South Carolina

ZIP/Postal Code

29627

Country

United States

Facility Name

Pfizer Investigational Site

City

Mt. Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Pfizer Investigational Site

City

Aberdeen

State/Province

South Dakota

ZIP/Postal Code

57401

Country

United States

Facility Name

Pfizer Investigational Site

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

Facility Name

Pfizer Investigational Site

City

Waterdown

State/Province

South Dakota

ZIP/Postal Code

57201

Country

United States

Facility Name

Pfizer Investigational Site

City

Watertown

State/Province

South Dakota

ZIP/Postal Code

57201

Country

United States

Facility Name

Pfizer Investigational Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38104

Country

United States

Facility Name

Pfizer Investigational Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Pfizer Investigational Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Facility Name

Pfizer Investigational Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Pfizer Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Pfizer Investigational Site

City

Bellaire

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230-2513

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75243

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78220

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229-3894

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Pfizer Investigational Site

City

Temple

State/Province

Texas

ZIP/Postal Code

76504

Country

United States

Facility Name

Pfizer Investigational Site

City

Waco

State/Province

Texas

ZIP/Postal Code

76708

Country

United States

Facility Name

Pfizer Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84102-3015

Country

United States

Facility Name

Pfizer Investigational Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Pfizer Investigational Site

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23454

Country

United States

Facility Name

Pfizer Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105-4631

Country

United States

Facility Name

Pfizer Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Pfizer Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98133

Country

United States

Facility Name

Pfizer Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

Facility Name

Pfizer Investigational Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Pfizer Investigational Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53209

Country

United States

Facility Name

Pfizer Investigational Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Pfizer Investigational Site

City

Cheyenne

State/Province

Wyoming

ZIP/Postal Code

82001

Country

United States

Facility Name

Pfizer Investigational Site

City

Provincia de Buenos Aires

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Concord

State/Province

New South Wales

ZIP/Postal Code

2139

Country

Australia

Facility Name

Pfizer Investigational Site

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Pfizer Investigational Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Pfizer Investigational Site

City

Herston

ZIP/Postal Code

QLD 4029

Country

Australia

Facility Name

Pfizer Investigational Site

City

Keswick

Country

Australia

Facility Name

Pfizer Investigational Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Pfizer Investigational Site

City

Diepenbeek

ZIP/Postal Code

3590

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Schiepsebos

ZIP/Postal Code

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Goiania

State/Province

ZIP/Postal Code

74175-080

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Duque de Caxias - Cuiaba

State/Province

ZIP/Postal Code

78043-306

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Rio de Janeiro

State/Province

ZIP/Postal Code

20020-020

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Rio de Janeiro

State/Province

ZIP/Postal Code

22271-100

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Sorocaba

State/Province

Sao Paulo

ZIP/Postal Code

18095-450

Country

Brazil

Facility Name

Pfizer Investigational Site

City

São Paulo

State/Province

ZIP/Postal Code

04020-060

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Sofia

ZIP/Postal Code

1301

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Sofia

ZIP/Postal Code

1303

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Sofia

ZIP/Postal Code

1504

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

Pfizer Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 2N6

Country

Canada

Facility Name

Pfizer Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6H 3X8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1M3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 1Y2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Hawkesbury

State/Province

Ontario

ZIP/Postal Code

K6A 1A1

Country

Canada

Facility Name

Pfizer Investigational Site

City

Hawkesbury

State/Province

Ontario

ZIP/Postal Code

K6A 3B2

Country

Canada

Facility Name

Pfizer Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4V2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5C 1R6

Country

Canada

Facility Name

Pfizer Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5C 2T2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1E2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

MB5 1W8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J8Y 6S9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 1S6

Country

Canada

Facility Name

Pfizer Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 1N8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Pointe-Claire

State/Province

Quebec

ZIP/Postal Code

H9R 4S3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 4J6

Country

Canada

Facility Name

Pfizer Investigational Site

City

Trois-Rivieres

State/Province

Quebec

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 0H6

Country

Canada

Facility Name

Pfizer Investigational Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 1N4

Country

Canada

Facility Name

Pfizer Investigational Site

City

Quebec

ZIP/Postal Code

G1S 2L6

Country

Canada

Facility Name

Pfizer Investigational Site

City

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

Facility Name

Pfizer Investigational Site

City

Santiago

Country

Chile

Facility Name

Pfizer Investigational Site

City

Zadar

ZIP/Postal Code

23000

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Pfizer Investigational Site

City

Ballerup

ZIP/Postal Code

2750

Country

Denmark

Facility Name

Pfizer Investigational Site

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

Facility Name

Pfizer Investigational Site

City

Tallinn

ZIP/Postal Code

10128

Country

Estonia

Facility Name

Pfizer Investigational Site

City

Tartu

ZIP/Postal Code

50410

Country

Estonia

Facility Name

Pfizer Investigational Site

City

Tartu

ZIP/Postal Code

51010

Country

Estonia

Facility Name

Pfizer Investigational Site

City

Tartu

Country

Estonia

Facility Name

Pfizer Investigational Site

City

Jyvaskyla

State/Province

FIN

ZIP/Postal Code

40100

Country

Finland

Facility Name

Pfizer Investigational Site

City

Jyvaskyla

ZIP/Postal Code

FIN-40100

Country

Finland

Facility Name

Pfizer Investigational Site

City

Jyväskylä

ZIP/Postal Code

40700

Country

Finland

Facility Name

Pfizer Investigational Site

City

Kuopio

ZIP/Postal Code

70210

Country

Finland

Facility Name

Pfizer Investigational Site

City

Kuopio

ZIP/Postal Code

70211

Country

Finland

Facility Name

Pfizer Investigational Site

City

Kuopio

ZIP/Postal Code

FIN-70211

Country

Finland

Facility Name

Pfizer Investigational Site

City

Lahti

Country

Finland

Facility Name

Pfizer Investigational Site

City

Oulu

ZIP/Postal Code

90 100

Country

Finland

Facility Name

Pfizer Investigational Site

City

Turku

ZIP/Postal Code

20100

Country

Finland

Facility Name

Pfizer Investigational Site

City

Lyon Cedex 03

ZIP/Postal Code

69437

Country

France

Facility Name

Pfizer Investigational Site

City

Orleans cedex 1

ZIP/Postal Code

45032

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Pfizer Investigational Site

City

Muenchen

ZIP/Postal Code

80809

Country

Germany

Facility Name

Pfizer Investigational Site

City

Zerbst

ZIP/Postal Code

39261

Country

Germany

Facility Name

Pfizer Investigational Site

City

Athens

ZIP/Postal Code

11526

Country

Greece

Facility Name

Pfizer Investigational Site

City

Hong Kong

Country

Hong Kong

Facility Name

Pfizer Investigational Site

City

PRC

Country

Hong Kong

Facility Name

Pfizer Investigational Site

City

Sai Ying Pung

Country

Hong Kong

Facility Name

Pfizer Investigational Site

City

Bekescsaba

ZIP/Postal Code

5600

Country

Hungary

Facility Name

Pfizer Investigational Site

City

H-6720 Szeged

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Kecskemet

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Mako

ZIP/Postal Code

6900

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Roma

ZIP/Postal Code

00136

Country

Italy

Facility Name

Pfizer Investigational Site

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Pfizer Investigational Site

City

Roma

ZIP/Postal Code

00189

Country

Italy

Facility Name

Pfizer Investigational Site

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Kaunas

ZIP/Postal Code

LT-50009

Country

Lithuania

Facility Name

Pfizer Investigational Site

City

Vilnius

ZIP/Postal Code

LT-04130

Country

Lithuania

Facility Name

Pfizer Investigational Site

City

Vilnius

ZIP/Postal Code

LT-10318

Country

Lithuania

Facility Name

Pfizer Investigational Site

City

seccion de Lomas Verdes

State/Province

Estado de Mexico

ZIP/Postal Code

CP 53120

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Mexico City

ZIP/Postal Code

03100

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Mexico D.F.

ZIP/Postal Code

11800

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Emmen

State/Province

ZIP/Postal Code

7824 AA

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Nijmegen

State/Province

ZIP/Postal Code

6525

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Amsterdam

State/Province

ZIP/Postal Code

1081

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Nijmegen

State/Province

ZIP/Postal Code

6532

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Eindhoven

ZIP/Postal Code

5611 NJ

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Rotterdam

ZIP/Postal Code

3001 HG

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Milford

State/Province

Auckland

Country

New Zealand

Facility Name

Pfizer Investigational Site

City

Christchurch

State/Province

ZIP/Postal Code

8143

Country

New Zealand

Facility Name

Pfizer Investigational Site

City

Auckland

Country

New Zealand

Facility Name

Pfizer Investigational Site

City

Dunedin

Country

New Zealand

Facility Name

Pfizer Investigational Site

City

Bergen

ZIP/Postal Code

NO-5094

Country

Norway

Facility Name

Pfizer Investigational Site

City

Hamar

ZIP/Postal Code

2317

Country

Norway

Facility Name

Pfizer Investigational Site

City

Oslo

ZIP/Postal Code

NO-0164

Country

Norway

Facility Name

Pfizer Investigational Site

City

Oslo

ZIP/Postal Code

NO-0176

Country

Norway

Facility Name

Pfizer Investigational Site

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

Facility Name

Pfizer Investigational Site

City

Trondheim

ZIP/Postal Code

NO-7006

Country

Norway

Facility Name

Pfizer Investigational Site

City

Katowice

ZIP/Postal Code

40-084

Country

Poland

Facility Name

Pfizer Investigational Site

City

Krakow

ZIP/Postal Code

30-007

Country

Poland

Facility Name

Pfizer Investigational Site

City

Krakow

ZIP/Postal Code

30-017

Country

Poland

Facility Name

Pfizer Investigational Site

City

Krakow

ZIP/Postal Code

30-224

Country

Poland

Facility Name

Pfizer Investigational Site

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

Pfizer Investigational Site

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Pfizer Investigational Site

City

Lublin

ZIP/Postal Code

20-090

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

00-315

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

00-418

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

00-655

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

00-699

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

00-909

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

02-341

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

02-796

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

03-335

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

04-730

Country

Poland

Facility Name

Pfizer Investigational Site

City

Wroclaw

ZIP/Postal Code

50-088

Country

Poland

Facility Name

Pfizer Investigational Site

City

Cluj-

State/Province

Napoca

ZIP/Postal Code

400000

Country

Romania

Facility Name

Pfizer Investigational Site

City

Bucharesti

ZIP/Postal Code

7000

Country

Romania

Facility Name

Pfizer Investigational Site

City

Bucharest

ZIP/Postal Code

7000

Country

Romania

Facility Name

Pfizer Investigational Site

City

Bucuresti

ZIP/Postal Code

050521

Country

Romania

Facility Name

Pfizer Investigational Site

City

Bucuresti

ZIP/Postal Code

70231

Country

Romania

Facility Name

Pfizer Investigational Site

City

Cluj-Napoca

ZIP/Postal Code

400349

Country

Romania

Facility Name

Pfizer Investigational Site

City

Iasi

ZIP/Postal Code

700111

Country

Romania

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

101990

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

107014

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

117036

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

119002

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

121356

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

127299

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

129010

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Saint Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

St Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

St. Petersburg

ZIP/Postal Code

1190068

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

St. Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

St. Petersburg

ZIP/Postal Code

199034

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Piestany

State/Province

Slovak Republic

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Bratislava

ZIP/Postal Code

826 06

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Bratislava

ZIP/Postal Code

833 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Bratislava

ZIP/Postal Code

83301

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Bratislava

ZIP/Postal Code

851 07

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Groenkloof, 0181

State/Province

Pretoria

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Bedford Gardens

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Johannesburg 2193

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Johannesburg, 2193

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Johannesburg

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Johannesburg

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Parow 7500

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Parow

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Pretoria, 0042

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Pretoria, 0181

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Pretoria

ZIP/Postal Code

0042

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Pretoria

ZIP/Postal Code

0181

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Somerset West, 7129

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Somerset West, 7130

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Somerset West

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Stellenbosch 7600

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

20569451

Citation

Christiansen C, Chesnut CH 3rd, Adachi JD, Brown JP, Fernandes CE, Kung AW, Palacios S, Levine AB, Chines AA, Constantine GD. Safety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled Phase 3 study of postmenopausal women with osteoporosis. BMC Musculoskelet Disord. 2010 Jun 22;11:130. doi: 10.1186/1471-2474-11-130.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3068A1-301&StudyName=Study%20Evaluating%20Bazedoxifene%20Acetate%20In%20Osteoporosis%20In%20Postmenopausal%20Women

Description

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Learn more about this trial

Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

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Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

Osteoporosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial