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

Verified by: Warner Chilcott, September 2011
First Received: December 19, 2007 | Last Updated: September 27, 2011 | Phase: Phase 3 | Start Date: June 2003
Overall Status: Completed | Estimated Enrollment: 32
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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...

Brief Summary

Official Title: “An Extension Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO”

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 Type: Interventional
  • Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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 (NCT01249261)

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

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 Investigator Information

Lead Investigator: Warner Chilcott Industry

Overall Clinical Trial Officials and Contacts

Dietrich H Wenderoth, MD Study Director Procter and Gamble  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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