Back to resultsStudy Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
bisphosphonates, calcium, and vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring Bone mineral density, bone morphogenetic protein, osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Community-dwelling, ambulatory (with or without assistive device), postmenopausal females, age greater than 65 years.
- BMD T-score (total hip or femoral neck) of -2.5 or less in at least 1 hip. Subjects with BMD T-scores of -2.0 or less may be enrolled if at least one of the following risk factors is also present:
- Age greater than 75 years
- Family (maternal) history of fragility fracture
- Previous fragility fracture (self) after age 45
- Subjects may either be treatment naïve or on a previously-established regimen ( greater than 1year, but less than 5 years duration) of bisphosphonate therapy. Subjects must be willing to comply with 1of the 3 protocol-designated oral bisphosphonates (risedronate, alendronate, or ibandronate sodium) with risedronate considered as first-line therapy.
Exclusion Criteria:
- Metabolic bone disorder or disease affecting bone and mineral metabolism (eg, Paget's disease, vitamin D deficiency [ less than 20 ng/mL], hyperparathyroidism, renal osteodystrophy, osteomalacia, hypocalcemia, hypercalcemia).
- Coagulopathy and/or history of venous thromboembolic events (deep vein thrombosis, pulmonary embolus, retinal vein thrombosis) within the past 12 months.
- Inflammatory arthritis including rheumatoid, psoriatic, or crystal-induced (gouty) arthritis, or those associated with systemic lupus erythematosus (SLE), spondyloarthropathy, Reiters syndrome, or Crohns disease.
Sites / Locations
- Arizona Research Center, Inc.
- John C. Lincoln Hospital - Deer Valley
- Tucson Orthopaedic Institute
- UC Davis Medical Center
- Florida Hospital Deland
- Florida Orthopaedic Associates, P.A.
- Florida Research Associates, LLC
- Victoria Park Imaging
- Diagnostic Professionals, Inc.
- Shrock Orthopedic Research
- Suncoast Clinical Research Inc
- Coastal orthopedic and Sports Medicine
- Westside Regional Medical Center
- Florida Arthritis & Osteoporosis Center
- Medical Center of Trinity
- Intensive Research Unit
- Washington University School of Medicine
- Center for Advanced Medicine
- Creighton University Medical Center
- Creighton University Osteoporosis Research Center
- Columbia University Medical Center
- Duke University Medical Center
- University Orthopedics Center
- University Orthopedics Center
- Prairie Lakes Healthcare Systems
- Brown Clinic
- Cool Spring Interventional, PLLC
- Center for Women's Health Research at Meharry Medical College
- Universitair Ziekenhuis Gent
- Andre Dumont Ziekenhuis - ZOL, Campus Andre Dumont
- Radiologica, Pracownia Rezonansu Magnetycznego i Tomografii Komputerowej
- Synexus Polska Sp. z o.o.
- Centralny Szpital Kliniczny MSWiA, Zaklad Diagnostyki Radiologicznej
- Clinica Ruber
- Instituto Palacios de Salud y Medicina de la Mujer
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
rhBMP-2/CPM , 1.0 mg/mL
rhBMP-2/CPM , 2.0 mg/mL
Oral bisphosphonate therapy (standard of care)
Outcomes
Primary Outcome Measures
Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA)
Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure. BMD is defined as a derived measure of bone density, generated by dividing the bone mineral content value obtained from a bone densitometry technique (for example, DXA) by the total area of the region scanned.
Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip
Time course distribution of volumetric Bone mineral density (BMD) for hip is assessed by volumetric Quantitative Computed Tomography (vQCT) technique which is a 4-detector spiral (helical) computed tomography (CT) scanner with designated calibration phantom, obtain a CT scan of the proximal femora (bilateral simultaneous acquisition with volumetric rendering) to identify the specified region of interests (ROIs) for volumetric parameter to be quantified, reconstruct images of both hips and send reconstructed data (in electronic format). The vQCT regions of interest are cortical, the subcortical and trabecular. Cortical and the subcortical BMD are distinguished from trabecular effects. Peeled trabecular BMD reflects the subtraction of the extended CPM. Integral BMD reflects the cortical, subcortical, and peeled trabecular regions (minus the extended Calcium phosphate matrix [CPM]).
Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck
Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure.
Secondary Outcome Measures
Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC)
Here, measurement of density of cortical and trabecular bone in various regions of interest (ROIs) in the femoral neck, proximal shaft, and individual trochanters and was calculated by Quantitative Computed Tomography (vQTC) in ROIs.
Number Participant Responses to Injectability Questionnaire Injected Population
Investigator documents preparation of the study medication evaluates injectability and product placement relative to desired location (for participants in active treatment groups). Surgeon performing the injection had to complete the questionnaire that evaluates ease of preparing the study medication, ability to administer study medication, and ability for the study medication to remain in the location it was administered.
Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline
Participants with significant change in serum biomarkers of bone formation and resorption from baseline are reported. Significant changes were judged by investigator.
Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip
Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. The percentage change from baseline in BMD for total hip (assessed by DXA) is presented for the contralateral (untreated) hip below.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00752557
Brief Title
Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD
Official Title
A PHASE 2, MULTICENTER, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, DOSE-FINDING AND SAFETY STUDY OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 (RHBMP-2)/CALCIUM PHOSPHATE MATRIX(CPM) IN SUBJECTS WITH DECREASED BONE MINERAL DENSITY
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 3, 2008 (Actual)
Primary Completion Date
April 24, 2015 (Actual)
Study Completion Date
April 24, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main purpose of this study is to assess whether a locally-administered rhBMP-2/CPM injection can rapidly increase bone mass in subjects at high risk for osteoporotic fractures of the hip. All subjects will receive standard treatment for low bone mass, consisting of bisphosphonates, calcium, and vitamin D (all taken by mouth). Subjects that are randomly selected to receive treatment with rhBMP-2 will receive an injection directly into the hip. The injection is given in a surgery room using a light anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Bone mineral density, bone morphogenetic protein, osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
rhBMP-2/CPM , 1.0 mg/mL
Arm Title
2
Arm Type
Experimental
Arm Description
rhBMP-2/CPM , 2.0 mg/mL
Arm Title
3
Arm Type
Active Comparator
Arm Description
Oral bisphosphonate therapy (standard of care)
Intervention Type
Drug
Intervention Name(s)
rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
Intervention Description
Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 1.0 mg/mL.
Intervention Type
Drug
Intervention Name(s)
rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
Intervention Description
Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 2.0 mg/mL.
Intervention Type
Drug
Intervention Name(s)
bisphosphonates, calcium, and vitamin D
Intervention Description
Oral bisphosphonate therapy
Primary Outcome Measure Information:
Title
Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA)
Description
Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure. BMD is defined as a derived measure of bone density, generated by dividing the bone mineral content value obtained from a bone densitometry technique (for example, DXA) by the total area of the region scanned.
Time Frame
Baseline, 12 months post dose
Title
Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip
Description
Time course distribution of volumetric Bone mineral density (BMD) for hip is assessed by volumetric Quantitative Computed Tomography (vQCT) technique which is a 4-detector spiral (helical) computed tomography (CT) scanner with designated calibration phantom, obtain a CT scan of the proximal femora (bilateral simultaneous acquisition with volumetric rendering) to identify the specified region of interests (ROIs) for volumetric parameter to be quantified, reconstruct images of both hips and send reconstructed data (in electronic format). The vQCT regions of interest are cortical, the subcortical and trabecular. Cortical and the subcortical BMD are distinguished from trabecular effects. Peeled trabecular BMD reflects the subtraction of the extended CPM. Integral BMD reflects the cortical, subcortical, and peeled trabecular regions (minus the extended Calcium phosphate matrix [CPM]).
Time Frame
At Month 12
Title
Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck
Description
Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure.
Time Frame
At Month 12
Secondary Outcome Measure Information:
Title
Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC)
Description
Here, measurement of density of cortical and trabecular bone in various regions of interest (ROIs) in the femoral neck, proximal shaft, and individual trochanters and was calculated by Quantitative Computed Tomography (vQTC) in ROIs.
Time Frame
24 months
Title
Number Participant Responses to Injectability Questionnaire Injected Population
Description
Investigator documents preparation of the study medication evaluates injectability and product placement relative to desired location (for participants in active treatment groups). Surgeon performing the injection had to complete the questionnaire that evaluates ease of preparing the study medication, ability to administer study medication, and ability for the study medication to remain in the location it was administered.
Time Frame
Participants were monitored after treatment administration (dosing period)
Title
Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline
Description
Participants with significant change in serum biomarkers of bone formation and resorption from baseline are reported. Significant changes were judged by investigator.
Time Frame
Baseline up to 12 months
Title
Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip
Description
Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. The percentage change from baseline in BMD for total hip (assessed by DXA) is presented for the contralateral (untreated) hip below.
Time Frame
36 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Community-dwelling, ambulatory (with or without assistive device), postmenopausal females, age greater than 65 years.
BMD T-score (total hip or femoral neck) of -2.5 or less in at least 1 hip. Subjects with BMD T-scores of -2.0 or less may be enrolled if at least one of the following risk factors is also present:
Age greater than 75 years
Family (maternal) history of fragility fracture
Previous fragility fracture (self) after age 45
Subjects may either be treatment naïve or on a previously-established regimen ( greater than 1year, but less than 5 years duration) of bisphosphonate therapy. Subjects must be willing to comply with 1of the 3 protocol-designated oral bisphosphonates (risedronate, alendronate, or ibandronate sodium) with risedronate considered as first-line therapy.
Exclusion Criteria:
Metabolic bone disorder or disease affecting bone and mineral metabolism (eg, Paget's disease, vitamin D deficiency [ less than 20 ng/mL], hyperparathyroidism, renal osteodystrophy, osteomalacia, hypocalcemia, hypercalcemia).
Coagulopathy and/or history of venous thromboembolic events (deep vein thrombosis, pulmonary embolus, retinal vein thrombosis) within the past 12 months.
Inflammatory arthritis including rheumatoid, psoriatic, or crystal-induced (gouty) arthritis, or those associated with systemic lupus erythematosus (SLE), spondyloarthropathy, Reiters syndrome, or Crohns disease.
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
Arizona Research Center, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
John C. Lincoln Hospital - Deer Valley
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Tucson Orthopaedic Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Florida Hospital Deland
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Florida Orthopaedic Associates, P.A.
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Florida Research Associates, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Victoria Park Imaging
City
DeLand
State/Province
Florida
ZIP/Postal Code
32724
Country
United States
Facility Name
Diagnostic Professionals, Inc.
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Shrock Orthopedic Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Suncoast Clinical Research Inc
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Coastal orthopedic and Sports Medicine
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Westside Regional Medical Center
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Florida Arthritis & Osteoporosis Center
City
Port Richey
State/Province
Florida
ZIP/Postal Code
34668
Country
United States
Facility Name
Medical Center of Trinity
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Intensive Research Unit
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Center for Advanced Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63310
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Creighton University Osteoporosis Research Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University Orthopedics Center
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
University Orthopedics Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Prairie Lakes Healthcare Systems
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201G
Country
United States
Facility Name
Brown Clinic
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
Cool Spring Interventional, PLLC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Center for Women's Health Research at Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208-3599
Country
United States
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Andre Dumont Ziekenhuis - ZOL, Campus Andre Dumont
City
Waterschei (Genk)
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Radiologica, Pracownia Rezonansu Magnetycznego i Tomografii Komputerowej
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
01-258
Country
Poland
Facility Name
Synexus Polska Sp. z o.o.
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA, Zaklad Diagnostyki Radiologicznej
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Clinica Ruber
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Instituto Palacios de Salud y Medicina de la Mujer
City
Madrid
ZIP/Postal Code
28009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3100N0-2213&StudyName=Study%20Evaluating%20Changes%20In%20Bone%20Mineral%20Density%20%28BMD%29%2C%20And%20Safety%20Of%20Rhbmp-2/CPM%20In%20Subjects%20With%20Decreased%20BMD
Description
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Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD
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