The purpose of this study is to evaluate the effects of two investigational drugs on osteoporosis in postmenopausal women...
Date First Received: September 21, 2004
Last Updated: March 14, 2008
Verified by: Merck, March 2008
Clinical Trial Phase: Phase 3 | Start Date: March 2003
Overall Status: Completed
Estimated Enrollment: 760
Brief Summary
Official Title: “A 12 Month Extension to: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Alendronate and Risedronate on Bone Mineral Density in Postmenopausal Women With Osteoporosis”
Condition Keyword(s):
The purpose of this study is to evaluate the effects of two investigational drugs on osteoporosis in postmenopausal women.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: MK0217, alendronate sodium/Duration of Intervention: 12 mo
- Drug: Comparator: risedronate / Duration of Intervention: 12 mo
Outcome Measures for this Clinical Trial
Primary Measures
- Mean percent change from baseline in hip trochanter bone mineral density (BMD)
Secondary Measures
- Mean percent change from baseline in PA lumbar spine, total hip, and femoral neck BMD
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Postmenopausal women with osteoporosis
Exclusion Criteria:
- Any known allergy to the study drug
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
Reid DM, Hosking D, Kendler D, Brandi ML, Wark JD, Weryha G, Marques-Neto JF, Gaines KA, Verbruggen N, Melton ME. Alendronic acid produces greater effects than risedronic acid on bone density and turnover in postmenopausal women with osteoporosis : results of FACTS -international. Clin Drug Investig. 2006;26(2):63-74.
Reid DM, Hosking D, Kendler D, Brandi ML, Wark JD, Marques-Neto JF, Weryha G, Verbruggen N, Hustad CM, Mahlis EM, Melton ME. A comparison of the effect of alendronate and risedronate on bone mineral density in postmenopausal women with osteoporosis: 24-month results from FACTS-International. Int J Clin Pract. 2008 Apr;62(4):575-84.
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00092040
Study ID Number: 2004_019
ClinicalTrials.gov Identifier: NCT00092040
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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