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A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab

Primary Purpose

Osteoporosis, Postmenopausal

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
denosumab
placebo
open-label denosumab
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal focused on measuring denosumab, Republic of Korea, dual energy x-ray absorptiometry

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Ambulatory Korean postmenopausal women with osteoporosis
  • greater than 5 years postmenopausal
  • aged 60 to 90 years old
  • absolute bone mineral density value consistent with a T-score less than -2.5 and greater than or equal to - 4.0 at the either the lumbar spine or total hip, as measured by dual energy x-ray absorptiometry. Subjects with a T-score less than -4.0 are at very high risk for fracture and will be excluded.

Exclusion Criteria:

  • previous or current metabolic bone disease, Paget's or Cushing's disease, or hyperprolactinemia
  • current hypo- or hyperparathyroidism or hypo- or hyperthyroidism unless on stable thyroid replacement therapy and TSH level meets criteria
  • rheumatoid arthritis
  • cirrhosis of the liver or unstable liver disease or ALT or AST greater than or equal to 2.0 times the upper limit of normal, or alkaline phosphatase and bilirubin greater than or equal to 1.5 times the upper limit of normal
  • medications used to treat osteoporosis, defined for type and duration of use, and including IV and oral bisphosphonates
  • medications that affect bone metabolism including parathyroid hormone or derivatives; anabolic steroids or testosterone; glucocorticosteroids; systemic hormone replacement therapy; selective estrogen receptor modulators; tibolone, calcitonin, and calcitriol or vitamin D derivatives; other bone active drugs including anticonvulsives (but not benzodiazepines) and heparin; chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, and gonadotropin-releasing hormone agonists
  • malignancy within 5 years except certain resected types
  • malabsorption syndrome or gastrointestinal disorders associated with malabsorption
  • abnormal calcium level
  • vitamin D deficiency
  • any laboratory abnormality that will prevent the subject from completing the study or interfere with interpretation of study results
  • severe renal impairment or on dialysis
  • impaired immune system or subject is taking immunosuppressants
  • oral or dental conditions including current or past history of osteomyelitis or osteonecrosis of the jaw; active dental or jaw condition with requires oral surgery; planned invasive dental procedure; un-healed dental or oral surgery
  • any disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures
  • any physical or psychiatric disorder that will prevent the subject from completing the study or interferes with study results
  • known to have tested positive for HIV
  • less than two lumbar vertebrae evaluable for DXA measurements
  • height, weight, or girth that may preclude accurate DXA measurements
  • drug or alcohol abuse within 12 months that interferes with understanding or completing the study
  • known sensitivity to mammalian cell-derived drug products
  • use of an investigational drug or device within 30 days of enrollment or currently receiving other investigational agent(s)

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

denosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind phase

placebo subcutaneous injection, single dose at the start of the 6-month double-blind phase

open-label phase follows the double-blind phase, denosumab 60mg subcutaneous injection, single dose at the start of the 6-month open-label phase

Outcomes

Primary Outcome Measures

Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6
Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 6 - measure at Baseline) divided by the measure at Baseline * 100.

Secondary Outcome Measures

Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1
Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1 - measure at Baseline) divided by the measure at Baseline * 100.
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6
Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covarience (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1/6 - measure at Baseline) divided by the measure at Baseline * 100.
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6
Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline * 100.
Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Change From Baseline in Hematocrit at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Change From Baseline in Mean Corpuscle Hemoglobin at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Change From Baseline in Mean Corpuscular Volume at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Change From Baseline in Red Blood Cell Count at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Change From Baseline in Red Cell Distribution Width at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6
Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (<50 or >120 Bits Per Minutes [bpm]), Systolic Blood Pressure (>170 Millimeters of Mercury [mmHg] or <100 mmHg) and Heart rate (>110 mmHg or <50 mmHg) are summarized. Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab
Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 6 was summarized.

Full Information

First Posted
October 20, 2011
Last Updated
April 17, 2014
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01457950
Brief Title
A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
Official Title
A Six Month Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study With a Six Month Open-Label Extension to Evaluate the Efficacy and Safety of Denosumab in Korean Postmenopausal Women With Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal
Keywords
denosumab, Republic of Korea, dual energy x-ray absorptiometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
denosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind phase
Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Description
placebo subcutaneous injection, single dose at the start of the 6-month double-blind phase
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
open-label phase follows the double-blind phase, denosumab 60mg subcutaneous injection, single dose at the start of the 6-month open-label phase
Intervention Type
Drug
Intervention Name(s)
denosumab
Intervention Description
double-blind phase: 60mg subcutaneous injection, single dose
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
double-blind phase: placebo subcutaneous injection, single dose
Intervention Type
Drug
Intervention Name(s)
open-label denosumab
Intervention Description
open-label phase: 60mg subcutaneous injection, single dose
Primary Outcome Measure Information:
Title
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6
Description
Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 6 - measure at Baseline) divided by the measure at Baseline * 100.
Time Frame
Baseline and Month 6
Secondary Outcome Measure Information:
Title
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1
Description
Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1 - measure at Baseline) divided by the measure at Baseline * 100.
Time Frame
Baseline and Month 1
Title
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6
Description
Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covarience (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1/6 - measure at Baseline) divided by the measure at Baseline * 100.
Time Frame
Baseline, Month 1 and Month 6
Title
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6
Description
Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline * 100.
Time Frame
Baseline, Months 1, 3 and 6
Title
Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)
Description
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Time Frame
From Baseline up to Month 6
Title
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6
Description
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time Frame
Baseline and Month 6
Title
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6
Description
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time Frame
Baseline and Month 6
Title
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6
Description
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time Frame
Baseline and Month 6
Title
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6
Description
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time Frame
Baseline and Month 6
Title
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6
Description
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time Frame
Baseline and Month 6
Title
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6
Description
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time Frame
Baseline and Month 6
Title
Change From Baseline in Hematocrit at Month 6
Description
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time Frame
Baseline and Month 6
Title
Change From Baseline in Mean Corpuscle Hemoglobin at Month 6
Description
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time Frame
Baseline and Month 6
Title
Change From Baseline in Mean Corpuscular Volume at Month 6
Description
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time Frame
Baseline and Month 6
Title
Change From Baseline in Red Blood Cell Count at Month 6
Description
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time Frame
Baseline and Month 6
Title
Change From Baseline in Red Cell Distribution Width at Month 6
Description
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time Frame
Baseline and Month 6
Title
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6
Description
Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (<50 or >120 Bits Per Minutes [bpm]), Systolic Blood Pressure (>170 Millimeters of Mercury [mmHg] or <100 mmHg) and Heart rate (>110 mmHg or <50 mmHg) are summarized. Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time Frame
Baseline and Month 6
Title
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab
Description
Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 6 was summarized.
Time Frame
Month 6
Other Pre-specified Outcome Measures:
Title
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab
Description
Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline * 100.
Time Frame
Baseline and Month 12
Title
Mean Percent Change From Month 6 in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Placebo
Description
Mean percent change from Month 6 in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 * 100.
Time Frame
Month 6 and Month 12
Title
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab
Description
Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline * 100.
Time Frame
Baseline and Month 12
Title
Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo
Description
Mean percent change from Month 6 in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 * 100.
Time Frame
Month 6 and Month 12
Title
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Denosumab
Description
Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline * 100.
Time Frame
Baseline and Month 12
Title
Median Percent Change From Month 6 in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Placebo
Description
Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by measure at Month 6 * 100.
Time Frame
Month 6 and Month 12
Title
Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase
Description
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Time Frame
From Month 6 to Month 12
Title
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12
Description
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time Frame
Baseline and Month 12
Title
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12
Description
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time Frame
Baseline and Month 12
Title
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12
Description
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time Frame
Baseline and Month 12
Title
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12
Description
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time Frame
Baseline and Month 12
Title
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12
Description
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time Frame
Baseline and Month 12
Title
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12
Description
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time Frame
Baseline and Month 12
Title
Change From Baseline in Hematocrit at Month 12
Description
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time Frame
Baseline and Month 12
Title
Change From Baseline in Mean Corpuscle Hemoglobin at Month 12
Description
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time Frame
Baseline and Month 12
Title
Change From Baseline in Red Blood Cell Count at Month 12
Description
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time Frame
Baseline and Month 12
Title
Change From Baseline in Red Cell Distribution Width at Month 12
Description
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time Frame
Baseline and Month 12
Title
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12
Description
Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (<50 or >120 Bits Per Minutes [bpm]), Systolic Blood Pressure (>170 Millimeters of Mercury [mmHg] or <100 mmHg) and Heart rate (>110 mmHg or <50 mmHg) are summarized. Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time Frame
Baseline and Month 12
Title
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12
Description
Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 12 was summarized.
Time Frame
Month 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ambulatory Korean postmenopausal women with osteoporosis greater than 5 years postmenopausal aged 60 to 90 years old absolute bone mineral density value consistent with a T-score less than -2.5 and greater than or equal to - 4.0 at the either the lumbar spine or total hip, as measured by dual energy x-ray absorptiometry. Subjects with a T-score less than -4.0 are at very high risk for fracture and will be excluded. Exclusion Criteria: previous or current metabolic bone disease, Paget's or Cushing's disease, or hyperprolactinemia current hypo- or hyperparathyroidism or hypo- or hyperthyroidism unless on stable thyroid replacement therapy and TSH level meets criteria rheumatoid arthritis cirrhosis of the liver or unstable liver disease or ALT or AST greater than or equal to 2.0 times the upper limit of normal, or alkaline phosphatase and bilirubin greater than or equal to 1.5 times the upper limit of normal medications used to treat osteoporosis, defined for type and duration of use, and including IV and oral bisphosphonates medications that affect bone metabolism including parathyroid hormone or derivatives; anabolic steroids or testosterone; glucocorticosteroids; systemic hormone replacement therapy; selective estrogen receptor modulators; tibolone, calcitonin, and calcitriol or vitamin D derivatives; other bone active drugs including anticonvulsives (but not benzodiazepines) and heparin; chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, and gonadotropin-releasing hormone agonists malignancy within 5 years except certain resected types malabsorption syndrome or gastrointestinal disorders associated with malabsorption abnormal calcium level vitamin D deficiency any laboratory abnormality that will prevent the subject from completing the study or interfere with interpretation of study results severe renal impairment or on dialysis impaired immune system or subject is taking immunosuppressants oral or dental conditions including current or past history of osteomyelitis or osteonecrosis of the jaw; active dental or jaw condition with requires oral surgery; planned invasive dental procedure; un-healed dental or oral surgery any disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures any physical or psychiatric disorder that will prevent the subject from completing the study or interferes with study results known to have tested positive for HIV less than two lumbar vertebrae evaluable for DXA measurements height, weight, or girth that may preclude accurate DXA measurements drug or alcohol abuse within 12 months that interferes with understanding or completing the study known sensitivity to mammalian cell-derived drug products use of an investigational drug or device within 30 days of enrollment or currently receiving other investigational agent(s)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Daegu
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
100-380
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
songpa-gu, Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab

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