Status:
COMPLETED
Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD
Lead Sponsor:
Pfizer
Conditions:
Osteoporosis
Eligibility:
FEMALE
65-85 years
Phase:
PHASE2
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 subj...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 3 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00752557
Start Date
December 3 2008
End Date
April 24 2015
Last Update
March 20 2020
Active Locations (35)
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1
Arizona Research Center, Inc.
Phoenix, Arizona, United States, 85023
2
John C. Lincoln Hospital - Deer Valley
Phoenix, Arizona, United States, 85027
3
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712
4
UC Davis Medical Center
Sacramento, California, United States, 95817