NCT00092066

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)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 717 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoporosis
• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 weeks

Timeline

• Start date: 2003-09-24
• Primary completion: 2004-05-01
• Completion: 2004-05-01
• First posted: 2004-09-24
• Last updated: 2024-08-14