A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis, Postmenopausal
Intervention: MK0217, /Duration of Treatment : 12 Months (Drug); Comparator : raloxifene hydrochloride /Duration of Treatment : 12 Months (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Bone Mineral Density (BMD) in PA lumbar spine at 12 months
Secondary outcome: Bone Mineral Density (BMD) in hip at 12 months; bone turnover at 6 and 12 months
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Additional Information
Related publications: 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.
Starting date: February 2001
Last updated: October 8, 2007
|
