To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption To confirm general safety of 5 mg daily risedronate as...
Date First Received: July 13, 2006
Last Updated: March 14, 2008
Verified by: Sanofi-Aventis, March 2008
Clinical Trial Phase: Phase 3 | Start Date: December 2002
Overall Status: Completed
Estimated Enrollment: 171
Brief Summary
Official Title: “A Two-Year, Multicenter, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study of Oral Risedronate 5 mg Daily in the Prevention of Osteoporosis in Osteopenic Postmenopausal Women (More Than 5 Years Postmenopausal)”
Condition Keyword(s):
Intervention(s):
To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women
To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption
To confirm general safety of 5 mg daily risedronate as compared to placebo
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Study Primary Completion Date: April 2005
Intervention(s) in this Clinical Trial
- Drug: risedronate
Outcome Measures for this Clinical Trial
Primary Measures
- Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA.
Secondary Measures
- Percent changes in proximal femur BMD from baseline at month 12 and 24 (DXA)
- Percent of responders (subjects with a positive change in lumbar spine BMD from baseline)at Month 12 and 24
- Percent changes in bone turnover markers after 12 and 24 months of treatment
- Physical examination and hematology tests before and after 12 and 24 months of treatment;Serum Chemistry before and after 6, 12 and 24 months of treatment
- Occurrence of adverse events at each visit with special interest for upper gastro-intestinal events
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Ambulatory, healthy postmenopausal women with
- Natural menopause and more than 5 years after their last menstrual period
- or surgical menopause and more than 5 years after surgery
- osteopenia (lumbar spine T score between 1 and 2.5 SD below the mean value in normal young women).
- With at least one risk factor for osteoporosis
Exclusion Criteria:
- Women who have received hormone replacement therapy (with estrogen and/or progestogen and/or androgen) or raloxifene within 3 months before visit 2 or calcitonin or calcitriol within 4 weeks before visit 2
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 45 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Sanofi-Aventis
Overall Clinical Trial Officials and Contacts
Välimäki Matti, MD Principal Investigator Division of Endocrinology, Helsinki University Central Hospital, Helsinki, Finland
Related Publications
Citations Reporting Results
Välimäki MJ, Farrerons-Minguella J, Halse J, Kröger H, Maroni M, Mulder H, Muñoz-Torres M, Sääf M, Snorre Øfjord E. Effects of risedronate 5 mg/d on bone mineral density and bone turnover markers in late-postmenopausal women with osteopenia: a multinational, 24-month, randomized, double-blind, placebo-controlled, parallel-group, phase III trial. Clin Ther. 2007 Sep;29(9):1937-49.
Additional Information
Information obtained from ClinicalTrials.gov on September 04, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00353080
Study ID Number: EFC6064
ClinicalTrials.gov Identifier: NCT00353080
Health Authority: Finland: National Agency for Medicines
Clinical Trials Authorship and Review
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