A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
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The purpose of this study is to test the safety, tolerability and effectiveness of an investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and deficiency during the treatment of osteoporosis in men and postmenopausal women.
A 15-Week, Double-Blind, Randomized, Active-Controlled, Multi-Center Study With 24-Week Extension to Evaluate the Safety, Tolerability, Efficacy of Alendronate 70 mg Plus Vitamin D3 2800 IU Combination Tablet in Men and Postmenopausal Women With Osteoporosis
Actual Study Start Date :
September 24, 2003
Actual Primary Completion Date :
May 1, 2004
Actual Study Completion Date :
May 1, 2004
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Ages Eligible for Study:
40 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Men or postmenopausal women who are osteoporotic
Vitamin D deficiency
Other disease of bone or mineral metabolism
Digestive disease causing malabsorption
Other significant medical conditions that are not adequately treated