A Study of MK0217A and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)

Phase 3

Completed

• Conditions: Osteoporosis; Vitamin D Deficiency

• Registration Number: NCT00092079
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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 treatment of osteoporosis in men and postmenopausal women.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2004-09-21
• Study First Submitted QC: 2004-09-23
• Study First Posted: 2004-09-24
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-07
• Last Update Posted: 2014-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 652

Inclusion Criteria

• Men or postmenopausal women who are osteoporotic

Exclusion Criteria

• Vitamin D deficiency
• Other disease of bone or mineral metabolism
• Digestive disease causing malabsorption
• Other medical conditions that are not adequately treated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety and tolerability; primary parameter assessed is the proportion of patients who develop hypercalcuria