NCT00389740CompletedPhase 3
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 400
- Primary Endpoint
- Bone Mineral Density (BMD) in PA lumbar spine at 12 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Bone Mineral Density (BMD) in PA lumbar spine at 12 months
Secondary Outcomes
- Bone Mineral Density (BMD) in hip at 12 months; bone turnover at 6 and 12 months
Investigators
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