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

Information source: Warner Chilcott
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postmenopausal Osteoporosis

Intervention: risedronate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Warner Chilcott

Official(s) and/or principal investigator(s):
Dietrich H Wenderoth, MD, Study Director, Affiliation: Procter and Gamble

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)

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

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)

Eligibility

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- Can not use any bone modifying substances except risedronate

Locations and Contacts

Research Site, Concord, Australia

Research Facility, Sienna, Italy

Research Facility, Warsaw, Poland

Research Facility, Barcelona, Spain

Research Facility, Goteborg, Sweden

Additional Information

Starting date: June 2003
Last updated: September 27, 2011

Page last updated: August 20, 2015

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