Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss
- Registration Number
- NCT00163137
- Lead Sponsor
- Ligand Pharmaceuticals
- Brief Summary
To compare the effects of 2 years of lasofoxifene treatment with 2 years of raloxifene 60 mg/day use and 2 years of placebo use on bone mineral density (BMD) of the lumbar spine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 540
Inclusion Criteria
- Postmenopausal women with low bone density (osteopenia) and screening labs, pelvic ultrasound, mammogram without significant findings
Exclusion Criteria
- Presence of metabolic bone disease, fractures, blood clots, or recent cancer.
- Any use of selective estrogen receptor modulators, investigational drugs, or recent use of osteoporosis treatments, certain hormones, or medication for blood clots or seizures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description raloxifene raloxifene raloxifene 60 mg/day Lasofoxifene 0.25 mg lasofoxifene lasofoxifene 0.25 mg/day Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Spine BMD after 2 years 2 years Lumbar Spine Bome Mineral Density
- Secondary Outcome Measures
Name Time Method Hip BMD and LDL-C after 2 years, vaginal pH and Maturation Index after 1 year Hip BMD= 24 months, LDL-C= 24 months, vaginal pH= 24 months, vaginal epithelial parabasel cells= 12 months Direct low density lipoprotein cholesterol (LDL-C) at 24 months, vaginal pH at 24 months, vaginal epithelial parabasal cells at 12 months, and total hip BMD at 24 months.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Seattle, Washington, United States