Osteoporosis
Conditions
Brief summary
The purpose of the study is to determine the safety and effectiveness of 2 doses of the investigational drug, lasofoxifene, compared to placebo (an inactive substance) in reducing new spinal fractures in women with osteoporosis.
Interventions
DRUGlasofoxifene
0.5 mg once per day, orally
OTHERplacebo
placebo
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
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Postmenopausal at least 5 years; Screening bone mineral density more than or equal to 2.5 S.D.s below the mean for young adults at the lumbar spine or femoral neck.
Exclusion criteria
Metabolic bone disease other than osteoporosis; Taking approved medications for osteoporosis; Have had a recent osteoporotic fracture (within 1 year) and/or have a bone mineral density more than 4.5 S.D.s below the mean for young adults at the lumbar spine or femoral neck.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New morphometric vertebral fractures | 3 years |
| New cases of breast cancer | 5 years |
| New non-vertebral fractures | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events | 3 years |
| All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events | 5 years |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Costa Rica, Croatia, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Lithuania, Mexico, Norway, Poland, Romania, Russia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed