A Study to Evaluate Two Investigational Drugs in Postmenopausal Women With Osteoporosis
The purpose of this study is to evaluate the effects of two investigational drugs on osteoporosis in postmenopausal women...
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”
The purpose of this study is to evaluate the effects of two investigational drugs on osteoporosis in postmenopausal women.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 Investigator Information
Lead Investigator: Merck Industry
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 February 12, 2012
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: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00092040
