Dose Response Study of Lasofoxifene in Postmenopausal Women With Osteoporosis - Japanese Asian Dose Evaluation
- Registration Number
- NCT00143273
- Lead Sponsor
- Ligand Pharmaceuticals
- Brief Summary
To establish the optimal dose of lasofoxifene that is fully effective in increasing the BMD in postmenopausal Asian women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 497
Inclusion Criteria
- postmenopausal Asian women with osteoporosis defined by low BMD
Exclusion Criteria
- Metabolic bone disease, use of other osteoporosis drugs or drugs interering with normal bone metabolism
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lasofoxifene Dose 1 Lasofoxifene 0.05 mg Lasofoxifene Dose 3 Lasofoxifene 0.5 mg Placebo Placebo 0 mg Lasofoxifene Dose 2 Lasofoxifene 0.25 mg
- Primary Outcome Measures
Name Time Method Effects of lasofoxifene compared to placebo on Bone Mineral Density (BMD) changes at the spine and hip after 1 year of treatment 12 months Percent change from baseline in lumbar spine BMD at Month 12
- Secondary Outcome Measures
Name Time Method Hip BMD, bone markers, lipids and new radiographic vertebral fractures at 1 year Month 6 and Month 12 Percent change from baseline in lumbar spine BMD at Month 6, percent change in baseline in hip BMD at Month 6 and Month 12, percent change from baseline in bone metabolism markers at Month 6 and Month 12, percent change from baseline in serum lipids, total cholesterol, high-density lipoprotein cholesterol, triglycerides, lipoprotein (a), apoliporpotein-A1, apolipoprotein-B at Month 6 and Month 12 and incidence of new vertebral fractures at Month 12
Trial Locations
- Locations (1)
Pfizer Investigational Site
Location not specified
Pfizer Investigational Site