At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy) and bisphosphonates, calcium, and vitamin D for Osteoporosis. Completed, enrolled 50 participants across 35 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 1.0 mg/mL.
Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 2.0 mg/mL.
Oral bisphosphonate therapy