A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)

Phase 3

Completed

• Conditions: Postmenopausal Osteoporosis

• Registration Number: NCT00092027
• Lead Sponsor: Organon and Co

Brief Summary

This study is to assess the safety and tolerability of MK0217 being evaluated to treat women with postmenopausal osteoporosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03-19
• Primary Completion: 2004-03-15
• Study Completion: 2004-03-15
• 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: Female
• Target Recruitment: 454

Inclusion Criteria

• Women with postmenopausal osteoporosis

Exclusion Criteria

• High risk for fractures
• Esophageal abnormalities
• Upper gastrointestinal symptoms that are not relieved with medication
• Metabolic bone disease (example - vitamin D deficiency)
• Medications that would affect the breakdown or build-up of bone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate the upper gastrointestinal (UGI) safety and tolerability of 6 months of treatment with once weekly alendronate 70 mg in an oral buffered solution in comparison to placebo in postmenopausal women with osteoporosis

Secondary Outcome Measures

Name	Time	Method
To evaluate the overall safety and tolerability of once weekly alendronate 70 mg oral buffered solution versus placebo
To evaluate the mean percent change from baseline in bone markers (BSAP, Urinary NTx) at 6 months