drugset / Trial / NCT00752557
Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2008-12-03
- Primary completion
- 2015-04-24
- Completion
- 2015-04-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rhBMP-2 | Protein / enzyme biologic | 1 mg/ml | Other |
| Subject | rhBMP-2 | Protein / enzyme biologic | 2 mg/ml | Other |
| Comparator | Calcium carbonate | Other / unclassified | — | Oral |
| Comparator | Vitamin D | Other / unclassified | — | Oral |