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| ID | Type | Description | Link |
|---|---|---|---|
| MK0217-219 | |||
| 2004_017 |
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This study is to assess the safety and tolerability of MK0217 being evaluated to treat women with postmenopausal osteoporosis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK0217, alendronate sodium/Duration of Treatment: 6 months | Drug | |||
| Comparator: placebo / Duration of Treatment: 6 months | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the upper gastrointestinal (UGI) safety and tolerability of 6 months of treatment with once weekly alendronate 70 mg in an oral buffered solution in comparison to placebo in postmenopausal women with osteoporosis |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the overall safety and tolerability of once weekly alendronate 70 mg oral buffered solution versus placebo | ||
| To evaluate the mean percent change from baseline in bone markers (BSAP, Urinary NTx) at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16257815 | Background | Cryer B, Binkley N, Simonelli C, Lewiecki EM, Lanza F, Chen E, Petruschke RA, Mullen C, de Papp AE. A randomized, placebo-controlled, 6-month study of once-weekly alendronate oral solution for postmenopausal osteoporosis. Am J Geriatr Pharmacother. 2005 Sep;3(3):127-36. doi: 10.1016/s1543-5946(05)80019-4. |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019386 | Alendronate |
| D000081206 | Duration of Therapy |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |