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
Abstract
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.
Conditions: Osteoporosis.
Primary outcome: Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA); Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip; Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck.
Enrollment: 50 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 50 participants or records.
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