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This study will evaluate the therapeutic effects and safety of odanacatib on bone mineral density in osteoporotic postmenopausal women who were previously treated with alendronate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Odanacatib | Experimental |
| |
| Alendronate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Odanacatib | Drug | Odanacatib 50 mg compressed tablet will be administered orally, once-a-week, for 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck | Baseline and Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in BMD of the Lumbar Spine, Total Hip, and Trochanter | Baseline and Month 24 |
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Inclusion Criteria:
Exclusion Criteria:
(within the last year) of drug or alcohol abuse or dependence
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| Alendronate | Drug | Alendronate 70 mg compressed tablets will be administered orally, once-a-week, for 24 months; and a reduced dose of 35 mg will be administered in the same fashion to a subset of women, Japanese participants only, for the same 24-month duration. |
|
|
| Placebo (odanacatib) | Other | One compressed tablet administered orally, once-a-week, for 24 months. |
|
| Cholecalciferol (Vitamin D3) | Dietary Supplement | Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months. |
|
| Calcium carbonate | Dietary Supplement | Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg. |
|
| Placebo (alendronate) | Other | One compressed tablet administered orally, once-a-week, for 24 months. |
|
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C527128 | odanacatib |
| D019386 | Alendronate |
| D002762 | Cholecalciferol |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
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