Osteoporosis
Conditions
Brief summary
To establish the optimal dose of lasofoxifene that is fully effective in increasing the BMD in postmenopausal Asian women.
Interventions
Sponsors
Ligand Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Japan, South Korea, Taiwan
Outcome results
None listed