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bisphosphonates, calcium, and vitamin D · 1 trial · 1 indication
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) |
| 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 |
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 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Precision BioSciences, Inc. | DTIL | 1 | N/A | Undisclosed |
| SI-BONE, Inc. | SIBN | 1 | - | Undisclosed |
Bisphosphonates, calcium, and vitamin D is a combination of small molecules being studied for the treatment of osteoporosis, a condition characterized by decreased bone mineral density. It is currently in Phase 2 clinical development as an investigational therapy for this indication.
Pfizer, Inc. (NYSE: PFE) is the developer of bisphosphonates, calcium, and vitamin D. The company is conducting clinical research on this combination therapy for osteoporosis.
Bisphosphonates, calcium, and vitamin D is in Phase 2 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. One Phase 2 trial has been completed.
Bisphosphonates, calcium, and vitamin D was studied in a completed Phase 2 trial with the identifier NCT00752557. This randomized, double-blind, active-controlled study evaluated changes in bone mineral density and safety in 50 female subjects aged 65 years and older with decreased bone mineral density.
The clinical trial NCT00752557 studied bisphosphonates, calcium, and vitamin D in combination with rhBMP-2/CPM, as indicated by the trial title. The study evaluated changes in bone mineral density and safety of this combination in subjects with decreased bone mineral density.