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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: | NCT00247273 |
The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
Condition | Intervention | Phase |
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Postmenopausal Osteoporosis |
Drug: risedronate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of PMO |
Enrollment: | 1294 |
Study Start Date: | October 2005 |
Study Completion Date: | April 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
5 mg risedronate, once daily for 2 years
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Drug: risedronate
tablet, 5 mg risedronate, once a day for 2 years
Drug: risedronate
oral, 150 mg risedronate, once a month for 2 years
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2: Experimental
150 mg risedronate taken once a month for 2 years
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Drug: risedronate
oral, 150 mg risedronate, once a month for 2 years
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The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Sal Bartelmo, MD | P&G |
Responsible Party: | Procter and Gamble Pharmaceuticals ( Sal Bartelmo, MD ) |
Study ID Numbers: | 2005032, EFC6062 AND HMRF004M/3001 |
Study First Received: | October 28, 2005 |
Last Updated: | July 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00247273 History of Changes |
Health Authority: | United States: Food and Drug Administration |
randomized controlled trial, osteoporosis, risedronate |
Calcium, Dietary Musculoskeletal Diseases Osteoporosis, Postmenopausal Calcium Channel Blockers Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Cardiovascular Agents Bone Diseases Risedronic acid |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Osteoporosis Calcium Channel Blockers Bone Diseases, Metabolic Bone Density Conservation Agents Cardiovascular Agents |
Bone Diseases Pharmacologic Actions Membrane Transport Modulators Musculoskeletal Diseases Therapeutic Uses Osteoporosis, Postmenopausal Risedronic acid |