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| ID | Type | Description | Link |
|---|---|---|---|
| MK0217A-230 | |||
| 2008_517 |
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To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis
Placebo will be administered over a 4 week, single-blind run-in phase. Calcium, as citrate-malate, will be administered throughout the study at an individualized dose supplementing the patient's daily dietary calcium intake to a total of approximately 1200 mg. At the end of the stabilization period, baseline calcium absorption will be determined and patients will be randomized to receive either MK0217A, or matching placebo once weekly for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MK0217A |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alendronate sodium (+) cholecalciferol | Drug | MK0217A, a tablet containing alendronate 70-mg and vitamin D3 2800 IU, once weekly for 4 weeks. All patients will be instructed to take the tablet fasting upon arising for the day with 6 to 8 oz. of plain water (i.e., tap), wait at least one-half hour while continuing to fast and before the first food, beverage (except water), or other medication. All patients must eat before lying down. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis | 4 Weeks |
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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 |
|---|---|---|---|
| 21448918 | Result | Shapses SA, Kendler DL, Robson R, Hansen KE, Sherrell RM, Field MP, Woolf E, Berd Y, Mantz AM, Santora AC 2nd. Effect of alendronate and vitamin D(3) on fractional calcium absorption in a double-blind, randomized, placebo-controlled trial in postmenopausal osteoporotic women. J Bone Miner Res. 2011 Aug;26(8):1836-44. doi: 10.1002/jbmr.395. |
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| Comparator: Placebo (unspecified) | Drug | MK0217A, Pbo tablet, once weekly for 4 weeks. All patients will be instructed to take the tablet fasting upon arising for the day with 6 to 8 oz. of plain water (i.e., tap), wait at least one-half hour while continuing to fast and before the first food, beverage (except water), or other medication. All patients must eat before lying down. |
|
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| 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 |
|---|---|
| D019386 | Alendronate |
| D002762 | Cholecalciferol |
| 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 |
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