4-Week Study to Assess the Effect of Alendronate and Vitamin D3 Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women (0217A-230)

Study Overview
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Brief Summary
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To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis

Detailed Description
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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.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled, Multicenter 4-Week Study to Assess the Effect of Alendronate 70 mg and Vitamin D3 2800 IU Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: alendronate sodium (+) cholecalciferol
* Drug: Comparator: Placebo (unspecified)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is a postmenopausal osteoporotic female The patient is willing to limit direct sunlight exposure during the course of the study The patient must be ambulatory The patient has serum 25-hydroxyvitamin D =25 ng/mL Exclusion Criteria: The patient is contraindicated to bisphosphonate therapy The patient has a vitamin D deficiency Patient will be excluded if their weight is above 85 kg The patient has a history of prior osteoporotic fracture The patient is currently or has received in the past treatment with effects on bone or calcium metabolism The patient has malabsorption syndrome The patient has active thyroid disease The patient has metabolic bone disease The patient had a myocardial infarction within 6 months of screening visit The patient has impaired renal function The patient is currently or has been a smoker in the last year

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MK0217A | Drug: alendronate sodium (+) cholecalciferol<br>* 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.<br>* Other names: MK0217A;|
| Placebo Comparator: 2<br>Placebo | Drug: Comparator: Placebo (unspecified)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |