Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD

Completed · Phase 2

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT00752557

Run by

Pfizer

People needed

50

Starts

2008-12-03

Expected to finish

2015-04-24

Last updated by the study team

2020-03-20

Who can join

Age: 65 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Arizona Research Center, Inc. — Phoenix, Arizona, United States
• John C. Lincoln Hospital - Deer Valley — Phoenix, Arizona, United States
• Tucson Orthopaedic Institute — Tucson, Arizona, 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
• Florida Research Associates, LLC — DeLand, Florida, United States
• Victoria Park Imaging — DeLand, Florida, United States
• Diagnostic Professionals, Inc. — Fort Lauderdale, Florida, United States
• Shrock Orthopedic Research — Fort Lauderdale, Florida, United States
• Suncoast Clinical Research Inc — New Port Richey, Florida, United States
• Coastal orthopedic and Sports Medicine — New Port Richey, Florida, United States
• Westside Regional Medical Center — Plantation, Florida, United States
• Florida Arthritis & Osteoporosis Center — Port Richey, Florida, United States
• Medical Center of Trinity — Trinity, Florida, United States
• Intensive Research Unit — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Center for Advanced Medicine — St Louis, Missouri, United States
• Creighton University Medical Center — Omaha, Nebraska, United States
• Creighton University Osteoporosis Research Center — Omaha, Nebraska, United States
• Columbia University Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Orthopedics Center — Altoona, Pennsylvania, United States
• University Orthopedics Center — State College, Pennsylvania, United States
• Prairie Lakes Healthcare Systems — Watertown, South Dakota, United States

Full record on ClinicalTrials.gov

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