Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis
- Registration Number
- NCT00383422
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to compare the effect of arzoxifene to raloxifene on the bone mineral density (bone strength).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 320
Inclusion Criteria
- Must have osteoporosis
- Must be between 50 and 75 years old and be able to walk
- Have at least two of your back bones that can be x-rayed
- Have not had a period in at least two years
- Be willing to have blood tests
Exclusion Criteria
- Have a bone disease other than osteoporosis
- History of estrogen dependent cancer
- History of stroke or certain heart problems
- Possibly have an allergy to raloxifene or arzoxifene
- Have certain abnormal lab values
- History of seizure disorder
- Have unexplained vaginal bleeding or an abnormal pap smear
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Arzoxifene - 2 Raloxifene -
- Primary Outcome Measures
Name Time Method Percent change in Lumbar Spine BMD baseline to 12 months
- Secondary Outcome Measures
Name Time Method Breast Density by mammogram screening and 12 months Secondary BMD measures of total hip and femoral neck at 6 and 12 months Biochemical markers of bone metabolism assessed baseline, 3, 6, and 12 months Assessment of coagulation parameters baseline, 3, 6, and 12 months
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇨🇳Tao-Yuan, Taiwan