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rhBMP-2/CPM · 5 trials · 4 indications
Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure. BMD is defined as a derived measure of bone density, generated by dividing the bone mineral content value obtained from a bone densitometry technique (for example, DXA) by the total area of the region scanned.
Time course distribution of volumetric Bone mineral density (BMD) for hip is assessed by volumetric Quantitative Computed Tomography (vQCT) technique which is a 4-detector spiral (helical) computed tomography (CT) scanner with designated calibration phantom, obtain a CT scan of the proximal femora (bilateral simultaneous acquisition with volumetric rendering) to identify the specified region of interests (ROIs) for volumetric parameter to be quantified, reconstruct images of both hips and send reconstructed data (in electronic format). The vQCT regions of interest are cortical, the subcortical and trabecular. Cortical and the subcortical BMD are distinguished from trabecular effects. Peeled trabecular BMD reflects the subtraction of the extended CPM. Integral BMD reflects the cortical, subcortical, and peeled trabecular regions (minus the extended Calcium phosphate matrix \[CPM\]).
Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | rhBMP-2/CPM , 1.0 mg/mL |
| 2 | EXPERIMENTAL | rhBMP-2/CPM , 2.0 mg/mL |
| 3 | ACTIVE_COMPARATOR | Oral bisphosphonate therapy (standard of care) |
| A | EXPERIMENTAL | 1.0 mg/mL rhBMP-2/CPM + SOC |
| B | EXPERIMENTAL | 2.0 mg/mL rhBMP-2/CPM + SOC |
| C | ACTIVE_COMPARATOR | Buffer/CPM + SOC |
| D | OTHER | Standard of Care Alone (SOC) |
| Name | Type | Description |
|---|---|---|
| rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy) | DRUG | Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 1.0 mg/mL. |
| bisphosphonates, calcium, and vitamin D | DRUG | Oral bisphosphonate therapy |
| rhBMP-2/CPM | DRUG | - |
| surgical intervention alone | OTHER | surgical internal fixation of fracture defines the standard of care group |
Inclusion Criteria: * 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 ...
rhBMP-2/CPM is an investigational small molecule developed by Pfizer, Inc. (PFE) for musculoskeletal conditions. It has been studied in clinical trials for fractures, osteoarthritis, osteoporosis, and radius fractures. It is not approved and remains in clinical development.
rhBMP-2/CPM has been studied in Phase 2 trials for fractures, including closed humerus fractures and hip fractures, and for osteoporosis with decreased bone mineral density. It has also been studied in osteoarthritis and radius fractures. It is investigational and not approved for any indication.
Pfizer, Inc. (ticker: PFE) is the developer of rhBMP-2/CPM. Pfizer sponsored the clinical trials evaluating the drug in fractures, osteoporosis, and osteoarthritis.
rhBMP-2/CPM is in Phase 2 development. Two Phase 2 trials and one Phase 1 trial have been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA.
Completed trials of rhBMP-2/CPM include NCT00752557 in osteoporosis, NCT00384852 in closed humerus fractures, NCT00384358 in hip fractures, and NCT00243295 in open wedge osteotomies. These trials enrolled a total of 247 participants across Phase 1 and Phase 2.