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Sponsors and Collaborators: |
Procter and Gamble Sanofi-Aventis |
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Information provided by: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT00577421 |
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
Condition | Intervention | Phase |
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Postmenopausal Osteoporosis |
Drug: risedronate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Extension Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO |
Enrollment: | 32 |
Study Start Date: | June 2003 |
Study Completion Date: | January 2006 |
Arms | Assigned Interventions |
---|---|
1: Experimental
5 mg/day risedronate
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Drug: risedronate
5 mg tablet of risedronate once a day for 2 years
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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
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia | |
Research Site | |
Concord, Australia | |
Italy | |
Research Facility | |
Sienna, Italy | |
Poland | |
Research Facility | |
Warsaw, Poland | |
Spain | |
Research Facility | |
Barcelona, Spain | |
Sweden | |
Research Facility | |
Goteborg, Sweden |
Study Director: | Dietrich H Wenderoth, MD | Procter and Gamble |
Responsible Party: | Procter & Gamble ( Dietrich Wenderoth, MD ) |
Study ID Numbers: | 2002157 |
Study First Received: | December 19, 2007 |
Last Updated: | March 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00577421 |
Health Authority: | United States: Food and Drug Administration |
Calcium, Dietary Musculoskeletal Diseases Osteoporosis, Postmenopausal Osteoporosis |
Bone Diseases, Metabolic Bone Diseases Risedronic acid |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Calcium Channel Blockers Bone Density Conservation Agents Cardiovascular Agents Pharmacologic Actions |