Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD
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
3 other identifiers
interventional
50
4 countries
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2008
Longer than P75 for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2008
CompletedFirst Posted
Study publicly available on registry
September 15, 2008
CompletedStudy Start
First participant enrolled
December 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2015
CompletedResults Posted
Study results publicly available
March 20, 2020
CompletedMarch 20, 2020
March 1, 2020
6.4 years
September 12, 2008
August 11, 2016
March 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Baseline, 12 months post dose
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 \[CPM\]).
At Month 12
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.
At Month 12
Secondary Outcomes (4)
Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC)
24 months
Number Participant Responses to Injectability Questionnaire Injected Population
Participants were monitored after treatment administration (dosing period)
Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline
Baseline up to 12 months
Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip
36 months
Study Arms (3)
1
EXPERIMENTALrhBMP-2/CPM , 1.0 mg/mL
2
EXPERIMENTALrhBMP-2/CPM , 2.0 mg/mL
3
ACTIVE COMPARATOROral bisphosphonate therapy (standard of care)
Interventions
Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 1.0 mg/mL.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (35)
Arizona Research Center, Inc.
Phoenix, Arizona, 85023, United States
John C. Lincoln Hospital - Deer Valley
Phoenix, Arizona, 85027, United States
Tucson Orthopaedic Institute
Tucson, Arizona, 85712, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Florida Hospital Deland
DeLand, Florida, 32720, United States
Florida Orthopaedic Associates, P.A.
DeLand, Florida, 32720, United States
Florida Research Associates, LLC
DeLand, Florida, 32720, United States
Victoria Park Imaging
DeLand, Florida, 32724, United States
Diagnostic Professionals, Inc.
Fort Lauderdale, Florida, 33311, United States
Shrock Orthopedic Research
Fort Lauderdale, Florida, 33316, United States
Suncoast Clinical Research Inc
New Port Richey, Florida, 34652, United States
Coastal orthopedic and Sports Medicine
New Port Richey, Florida, 34653, United States
Westside Regional Medical Center
Plantation, Florida, 33324, United States
Florida Arthritis & Osteoporosis Center
Port Richey, Florida, 34668, United States
Medical Center of Trinity
Trinity, Florida, 34655, United States
Intensive Research Unit
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Center for Advanced Medicine
St Louis, Missouri, 63310, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Creighton University Osteoporosis Research Center
Omaha, Nebraska, 68131, United States
Columbia University Medical Center
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University Orthopedics Center
Altoona, Pennsylvania, 16602, United States
University Orthopedics Center
State College, Pennsylvania, 16801, United States
Prairie Lakes Healthcare Systems
Watertown, South Dakota, 57201G, United States
Brown Clinic
Watertown, South Dakota, 57201, United States
Cool Spring Interventional, PLLC
Franklin, Tennessee, 37067, United States
Center for Women's Health Research at Meharry Medical College
Nashville, Tennessee, 37208-3599, United States
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Andre Dumont Ziekenhuis - ZOL, Campus Andre Dumont
Waterschei (Genk), 3600, Belgium
Synexus Polska Sp. z o.o.
Warsaw, Masovian Voivodeship, 01-192, Poland
Radiologica, Pracownia Rezonansu Magnetycznego i Tomografii Komputerowej
Warsaw, Masovian Voivodeship, 01-258, Poland
Centralny Szpital Kliniczny MSWiA, Zaklad Diagnostyki Radiologicznej
Warsaw, Masovian Voivodeship, 02-507, Poland
Clinica Ruber
Madrid, 28006, Spain
Instituto Palacios de Salud y Medicina de la Mujer
Madrid, 28009, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
46 participants enrolled; further enrollment suspended due to safety signal. Participants completed long-term follow up per protocol; extra 2 years per protocol amendment. Sample size small to draw conclusions, to conduct efficacy interim analysis.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2008
First Posted
September 15, 2008
Study Start
December 3, 2008
Primary Completion
April 24, 2015
Study Completion
April 24, 2015
Last Updated
March 20, 2020
Results First Posted
March 20, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will share
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.