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Sponsors and Collaborators: |
Sanofi-Aventis Procter and Gamble |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00549068 |
To compare the subject satisfaction rating in women treated for postmenopausal osteoporosis with Actonel 35mg Once-a-Week for 24 weeks, and receiving feedback information, after 12 weeks of treatment, based on bone resorption marker results using the NTx Point-Of-Care (POC) device, to similar women treated as per regular clinical practice
Condition | Intervention | Phase |
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Osteoporosis, Postmenopausal |
Drug: Risedronate Sodium (Actonel) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Impact of NTx Point of Care (POC) Device on Patient Satisfication With Actonel 35mg Once a Seek Treatment a Multicenter Prospective Open Label Randomized Controlled Community Practice-Based Study |
Enrollment: | 2433 |
Study Start Date: | February 2003 |
Study Completion Date: | November 2004 |
Ages Eligible for Study: | 18 Years and older |
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.
Responsible Party: | sanofi-aventis ( Study Director ) |
Study ID Numbers: | HMR4003B_4031 |
Study First Received: | October 24, 2007 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00549068 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
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 |