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)

Phase 3

Completed

• Conditions: Osteoporosis; Vitamin D Deficiency

• Registration Number: NCT00092066
• Lead Sponsor: Organon and Co

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 the treatment of osteoporosis in men and postmenopausal women.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09-24
• Primary Completion: 2004-05-01
• Study Completion: 2004-05-01
• Study First Submitted: 2004-09-21
• Study First Submitted QC: 2004-09-23
• Study First Posted: 2004-09-24
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 717

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 significant medical conditions that are not adequately treated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients with Vitamin D insufficiency (defined as serum 25-hydroxyvitamin levels <15 ng/mL) after 15 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with vitamin D deficiency (serum 25-hydroxyvitamin D levels <9 ng/mL) after 15 weeks of treatment.