Back to resultsA Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)
Primary Purpose
Osteoporosis, Postmenopausal
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0217, /Duration of Treatment : 12 Months
Comparator : raloxifene hydrochloride /Duration of Treatment : 12 Months
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis, Postmenopausal
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Bone Mineral Density (BMD) in PA lumbar spine at 12 months
Secondary Outcome Measures
Bone Mineral Density (BMD) in hip at 12 months; bone turnover at 6 and 12 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00389740
Brief Title
A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 2, 2001 (Actual)
Primary Completion Date
January 16, 2003 (Actual)
Study Completion Date
January 16, 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0217, /Duration of Treatment : 12 Months
Intervention Type
Drug
Intervention Name(s)
Comparator : raloxifene hydrochloride /Duration of Treatment : 12 Months
Primary Outcome Measure Information:
Title
Bone Mineral Density (BMD) in PA lumbar spine at 12 months
Secondary Outcome Measure Information:
Title
Bone Mineral Density (BMD) in hip at 12 months; bone turnover at 6 and 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
15243278
Citation
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. doi: 10.1097/01.gme.0000119981.77837.1f.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)
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