Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD
- Conditions
- Osteoporosis
- Interventions
- Drug: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)Drug: bisphosphonates, calcium, and vitamin D
- Registration Number
- NCT00752557
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy) rhBMP-2/CPM , 1.0 mg/mL 3 bisphosphonates, calcium, and vitamin D Oral bisphosphonate therapy (standard of care) 2 rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy) rhBMP-2/CPM , 2.0 mg/mL
- Primary Outcome Measures
Name Time Method Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck At Month 12 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.
Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) Baseline, 12 months post dose 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 At Month 12 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 \[CPM\]).
- Secondary Outcome Measures
Name Time Method Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC) 24 months 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 of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline Baseline up to 12 months 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 36 months 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.
Number Participant Responses to Injectability Questionnaire Injected Population Participants were monitored after treatment administration (dosing period) 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.
Trial Locations
- Locations (34)
Florida Arthritis & Osteoporosis Center
🇺🇸Port Richey, Florida, United States
Victoria Park Imaging
🇺🇸DeLand, Florida, United States
Suncoast Clinical Research Inc
🇺🇸New Port Richey, Florida, United States
Shrock Orthopedic Research
🇺🇸Fort Lauderdale, Florida, United States
University Orthopedics Center
🇺🇸State College, Pennsylvania, United States
Andre Dumont Ziekenhuis - ZOL, Campus Andre Dumont
🇧🇪Waterschei (Genk), Belgium
Westside Regional Medical Center
🇺🇸Plantation, Florida, United States
Tucson Orthopaedic Institute
🇺🇸Tucson, Arizona, United States
Cool Spring Interventional, PLLC
🇺🇸Franklin, Tennessee, United States
Instituto Palacios de Salud y Medicina de la Mujer
🇪🇸Madrid, Spain
Arizona Research Center, Inc.
🇺🇸Phoenix, Arizona, United States
John C. Lincoln Hospital - Deer Valley
🇺🇸Phoenix, Arizona, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Center for Women's Health Research at Meharry Medical College
🇺🇸Nashville, Tennessee, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Florida Hospital Deland
🇺🇸DeLand, Florida, United States
Florida Orthopaedic Associates, P.A.
🇺🇸DeLand, Florida, United States
Coastal orthopedic and Sports Medicine
🇺🇸New Port Richey, Florida, United States
Florida Research Associates, LLC
🇺🇸DeLand, Florida, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Center for Advanced Medicine
🇺🇸Saint Louis, Missouri, United States
Radiologica, Pracownia Rezonansu Magnetycznego i Tomografii Komputerowej
🇵🇱Warsaw, Mazowieckie, Poland
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Clinica Ruber
🇪🇸Madrid, Spain
Prairie Lakes Healthcare Systems
🇺🇸Watertown, South Dakota, United States
Intensive Research Unit
🇺🇸Saint Louis, Missouri, United States
Diagnostic Professionals, Inc.
🇺🇸Fort Lauderdale, Florida, United States
Medical Center of Trinity
🇺🇸Trinity, Florida, United States
Creighton University Osteoporosis Research Center
🇺🇸Omaha, Nebraska, United States
Brown Clinic
🇺🇸Watertown, South Dakota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Synexus Polska Sp. z o.o.
🇵🇱Warszawa, Mazowieckie, Poland
Centralny Szpital Kliniczny MSWiA, Zaklad Diagnostyki Radiologicznej
🇵🇱Warszawa, Mazowieckie, Poland
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States