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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00790101 |
This is a multi-center, randomized, double-blind, double-dummy study designed to compare the effects of risedronate, raloxifene, and placebo on BMD, bone turnover markers, and other markers of anabolic activity in postmenopausal women who previously received HRT.
Condition | Intervention | Phase |
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Osteoporosis, Postmenopausal |
Drug: Risedronate Drug: Raloxifene Other: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | An 18-Month, Multicenter, Parallel-Group Study to Determine The Relative Efficacy of Risedronate Versus Raloxifene in Subjects Who Have Discontinued Hormone Replacement Therapy (HRT) for Early Intervention in Osteoporosis |
Enrollment: | 6 |
Study Start Date: | June 2004 |
Study Completion Date: | October 2004 |
Arms | Assigned Interventions |
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1: Experimental
Risedronate 35mg once a week
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Drug: Risedronate |
2: Active Comparator
Raloxifene 60mg daily
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Drug: Raloxifene |
3: Placebo Comparator | Other: Placebo |
Ages Eligible for Study: | up to 65 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
Responsible Party: | Sanofi-Aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | HMR4003B/4033 |
Study First Received: | November 11, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00790101 History of Changes |
Health Authority: | United States: Institutional Review Board |
Estrogen Antagonists Estrogens Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis Calcium Channel Blockers Bone Diseases, Metabolic Bone Density Conservation Agents Cardiovascular Agents |
Selective Estrogen Receptor Modulators Bone Diseases Hormones Estrogen Receptor Modulators Calcium, Dietary Raloxifene Musculoskeletal Diseases Osteoporosis, Postmenopausal Risedronic acid |
Estrogen Antagonists Molecular Mechanisms of Pharmacological Action Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis Calcium Channel Blockers Bone Diseases, Metabolic Bone Density Conservation Agents Cardiovascular Agents |
Selective Estrogen Receptor Modulators Bone Diseases Pharmacologic Actions Membrane Transport Modulators Estrogen Receptor Modulators Raloxifene Musculoskeletal Diseases Therapeutic Uses Osteoporosis, Postmenopausal Risedronic acid |