Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO

Phase 3

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: risedronate

• Registration Number: NCT00577421
• Lead Sponsor: Warner Chilcott

Brief Summary

A 2-year, Multicenter, Open-label, Phase IIIb Extension Study to Assess Bone Mineral Density and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women with Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, RVE1998080, and RVE2001079 (NCT01249261)

Detailed Description

A 2-year, Multicenter, Open-label, Phase IIIb Extension Study to Assess Bone Mineral Density and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women with Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, RVE1998080, and RVE2001079 (NCT01249261)

Study Timeline

• Study Start: 2003-06
• Study Completion: 2006-01
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-20
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-27
• Last Update Posted: 2011-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

• have satisfactorily completed Clinical Study RVE2001079 (Year 8 extension study)

Exclusion Criteria

• Can not use any bone modifying substances except risedronate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	risedronate	5 mg/day risedronate

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability profile of 5 mg daily oral risedronate therapy administered for 2 years in patients with post-menopausal osteoporosis, who had received risedronate for 2 or 7 years and then had a risedronate-free year.	2 years

Trial Locations

Locations (2)

Research Site; 🇦🇺 Concord, Australia

Research Facility; 🇸🇪 Goteborg, Sweden