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Sponsors and Collaborators: |
Sanofi-Aventis Procter and Gamble |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00460733 |
The purpose of this study is to evaluate the efficacy and safety of risedronate sodium (Actonel®) after a wrist fracture in postmenopausal women.
Condition | Intervention | Phase |
---|---|---|
Colles' Fracture |
Drug: Risedronate sodium Drug: Calcium & Vitamine D3 |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Local (Brazil) Study, Multicenter, Opened, Comparative, Randomized, With Parallel Groups, Phase IV, in Post Menopausal Woman With Colles' Fracture of the Risedronate Sodium Usage in the Consolidation and in the Callus of the Colles'Fracture. |
Estimated Enrollment: | 140 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Risedronate sodium
Actonel® 35 mg (risedronate sodium) and 1000 mg of calcium and 400 UI of Vitamine D3
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2: Active Comparator |
Drug: Calcium & Vitamine D3
1000 mg of calcium and 400 UI of Vitamine D3
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact: Public Registry GMA | publicregistrygma@sanofi-aventis.com |
Brazil | |
Sanofi-aventis administrative office | Recruiting |
São Paulo, Brazil |
Study Director: | Jaderson Lima | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | RISED_L_01930 |
Study First Received: | April 13, 2007 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00460733 |
Health Authority: | Brazil: National Health Surveillance Agency |
Tocopherol acetate Etidronic Acid Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Radius Fractures Alpha-Tocopherol |
Tocopherols Calcium, Dietary Vitamin E Colles' Fracture Menopause Risedronic acid |
Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Calcium Channel Blockers Bone Density Conservation Agents Cardiovascular Agents |
Protective Agents Pharmacologic Actions Membrane Transport Modulators Vitamins Therapeutic Uses Micronutrients |