Osteoporosis
Conditions
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.
Interventions
Sponsors
Ligand Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
48 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spine BMD after 2 years | 2 years | Lumbar Spine Bome Mineral Density |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed