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Sponsors and Collaborators: |
Sanofi-Aventis Procter and Gamble |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00453492 |
The primary objective is to compare subject satisfaction of once a week dosing of 35 mg Actonel to once daily dosing of 5 mg Actonel in postmenopausal osteoporotic women.
The secondary objectives are to measure compliance (50 % drug taken), and persistence, [and urinary NTx (N-telopeptides) (optional)].
Condition | Intervention | Phase |
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Osteoporosis, Postmenopausal |
Drug: risedronate sodium |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Prospective, Randomized, 2-Way Crossover, Open-Label Study pn Postmenopausal Women With Osteoporosis Examining Subject Satisfaction and Compliance When Risedronate Sodium (Actonel) in Administered 35mg Once a Week or 5mg Once Daily |
Estimated Enrollment: | 246 |
Study Start Date: | January 2004 |
Ages Eligible for Study: | 55 Years to 80 Years |
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.
Study ID Numbers: | HMR4003B_4036 |
Study First Received: | March 28, 2007 |
Last Updated: | March 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00453492 History of Changes |
Health Authority: | Turkey: Ministry of Health |
Calcium, Dietary Etidronic Acid Musculoskeletal Diseases Osteoporosis, Postmenopausal Calcium Channel Blockers Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Cardiovascular Agents Bone Diseases Risedronic acid Menopause |
Etidronic 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 |