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...
Date First Received: December 19, 2007
Last Updated: March 4, 2008
Verified by: Procter and Gamble, March 2008
Clinical Trial Phase: Phase 3 | Start Date: June 2003
Overall Status: Completed
Estimated Enrollment: 32
Brief Summary
Official Title: “An Extension Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO”
Condition Keyword(s):
Intervention(s):
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
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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
Intervention(s) in this Clinical Trial
- Drug: risedronate
- 5 mg tablet of risedronate once a day for 2 years
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- 5 mg/day risedronate
Outcome Measures for this Clinical Trial
Primary Measures
- 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.
- Time Frame: 2 years
Safety Issue?: Yes
- Time Frame: 2 years
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- have satisfactorily completed Clinical Study RVE2001079 (Year 8 extension study)
Exclusion Criteria:
- Can not use any bone modifying substances except risedronate
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 55 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Procter and Gamble
Overall Clinical Trial Officials and Contacts
Dietrich H Wenderoth, MD Study Director Procter and Gamble
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00577421
Study ID Number: 2002157
ClinicalTrials.gov Identifier: NCT00577421
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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