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The purpose of this study is to evaluate the efficacy and safety of an investigational drug in postmenopausal women with osteoporosis. The primary hypothesis of this study is that in postmenopausal women with osteoporosis, oral monthly ibandronate, at doses of 100 mg and 150 mg, does not achieve persistence in reduction of bone resorption throughout the monthly dosing interval, as demonstrated by a larger change in the serum carboxyterminal crosslinked telopeptide of Type I collagen (CTX-I) log-transformed fraction from baseline four weeks post dose compared to one week post dose, during the third month of treatment, in the participants taking ibandronate than in the participants taking placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive 3 placebo tablets once a month, for 3 months, on the first day of each treatment cycle. |
|
| ibandronate 100 mg | Experimental | Participants will receive 2 ibandronate 50 mg tablets and 1 placebo tablet once a month, for 3 months, on the first day of each treatment cycle. |
|
| ibandronate 150 mg | Experimental | Participants will receive 3 ibandronate 50 mg tablets once a month, for 3 months, on the first day of each treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | tablets |
| |
| ibandronate |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum levels of CTX-I (log-transformed fraction) from Week 9 to Week 12 | Baseline, Week 9, Week 12 |
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Inclusion Criteria: -postmenopausal for at least 3 years, with osteoporosis at any of the following sites: [BMD > 2.0 standard deviations below young normal mean bone mass for the hip trochanter, PA lumbar spine (L1 to L4), total hip, or femoral neck based on the normative database provided by each individual manufacturer].
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077557 | Ibandronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Drug |
50 mg tablets |
|
| D009750 |
| Nutritional and Metabolic Diseases |