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
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