Conditions: Osteoporosis
Keywords: Bone mineral density bone morphogenetic protein osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 50
Healthy volunteers: no

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:

Arms:
arm 1: rhBMP-2/CPM , 1.0 mg/mL arm 2: rhBMP-2/CPM , 2.0 mg/mL arm 3: Oral bisphosphonate therapy (standard of care)

Interventions: intervention 1: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy) intervention 2: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy) intervention 3: bisphosphonates, calcium, and vitamin D
Intervention descriptions: intervention 1: Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 1.0 mg/mL. intervention 2: Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 2.0 mg/mL. intervention 3: Oral bisphosphonate therapy

Protocol document: