A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)
Phase 3
Completed
- Conditions
- Osteoporosis, Postmenopausal
- Registration Number
- NCT00389740
- Lead Sponsor
- Organon and Co
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 400
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Bone Mineral Density (BMD) in PA lumbar spine at 12 months
- Secondary Outcome Measures
Name Time Method Bone Mineral Density (BMD) in hip at 12 months; bone turnover at 6 and 12 months