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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00616694 |
To evaluate the effect of subject knowledge of their disease status on persistence in subjects receiving Actonel 5 mg daily over a 12-month period for the prevention and treatment of GIO.
Condition | Intervention | Phase |
---|---|---|
Osteoporosis |
Drug: Actonel |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Multicenter Parallel Group Study to Determine if Knowledge of Baseline Vertebral Fracture Prevalence (as Determined by Hologic IVA) and Bone Turnover Marker Determinations Improves Persistence With Actonel 5mg Daily Therapy in Subjects Receiving Chronic Glucocorticoid Therapy |
Enrollment: | 248 |
Study Start Date: | July 2002 |
Study Completion Date: | December 2004 |
Ages Eligible for Study: | 30 Years to 85 Years |
Genders Eligible for Study: | Both |
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_4027 |
Study First Received: | February 5, 2008 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00616694 History of Changes |
Health Authority: | United States: Institutional Review Board |
Hormone Antagonists Fractures, Bone Hormones, Hormone Substitutes, and Hormone Antagonists Spinal Fractures Wounds and Injuries Calcium Channel Blockers Osteoporosis Disorders of Environmental Origin Bone Density Conservation Agents Bone Diseases, Metabolic Cardiovascular Agents |
Hormones Glucocorticoids Bone Diseases Calcium, Dietary Vitamin D Musculoskeletal Diseases Spinal Injuries Vitamins Back Injuries Risedronic acid |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Fractures, Bone Hormones, Hormone Substitutes, and Hormone Antagonists Spinal Fractures Wounds and Injuries Calcium Channel Blockers Osteoporosis Disorders of Environmental Origin Bone Density Conservation Agents Bone Diseases, Metabolic |
Cardiovascular Agents Bone Diseases Glucocorticoids Hormones Pharmacologic Actions Membrane Transport Modulators Musculoskeletal Diseases Spinal Injuries Therapeutic Uses Back Injuries Risedronic acid |