The purpose of this study is to compare how well alendronate and raloxifene increase the bone density in women who have osteoporosis and have experienced menopause...
Date First Received: October 18, 2006
Last Updated: September 30, 2008
Verified by: Merck, September 2008
Clinical Trial Phase: Phase 3 | Start Date: February 2001
Overall Status: Completed
Estimated Enrollment: 400
Brief Summary
Official Title: “A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Alendronate and Raloxifene on Bone Mineral Density in Postmenopausal Women With Osteoporosis”
Condition Keyword(s):
The purpose of this study is to compare how well alendronate and raloxifene increase the bone density in women who have osteoporosis and have experienced menopause.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Study Primary Completion Date: January 2003
Intervention(s) in this Clinical Trial
- Drug: MK0217, /Duration of Treatment : 12 Months
- Drug: Comparator : raloxifene hydrochloride /Duration of Treatment : 12 Months
Outcome Measures for this Clinical Trial
Primary Measures
- Bone Mineral Density (BMD) in PA lumbar spine at 12 months
Secondary Measures
- Bone Mineral Density (BMD) in hip at 12 months; bone turnover at 6 and 12 months
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patient is postmenopausal (or surgically menopausal) for at least 6 months
- Patient must be diagnosed with osteoporosis
- Patient has spinal anatomy suitable for DEXA of the lumbar spine
Exclusion Criteria:
- Patient is receiving or has received treatment prior to randomization which might influence bone turnover
- Patient has a history of or evidence for metabolic bone disease (other than postmenopausal bone loss)
- Patient is receiving or is expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism
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
Luckey M, Kagan R, Greenspan S, Bone H, Kiel RD, Simon J, Sackarowitz J, Palmisano J, Chen E, Petruschke RA, de Papp AE. Once-weekly alendronate 70 mg and raloxifene 60 mg daily in the treatment of postmenopausal osteoporosis. Menopause. 2004 Jul-Aug;11(4):405-15.
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00389740
Study ID Number: 2006_537
ClinicalTrials.gov Identifier: NCT00389740
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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