Bone Loss
Conditions
Keywords
Osteoporosis, lasofoxifene, bone density, bone markers
Brief summary
The objective of the study is to demonstrate the effects that lasofoxifene has on serum markers of bone metabolism.
Interventions
DRUGLasofoxifene
Oral tablet, 0.25 mg, daily, 2 years
OTHERPlacebo
Matching placebo tablet given once daily for 2 years
Sponsors
Ligand Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women over 50 years who have low bone mineral density.
Exclusion criteria
* Women who are under 50 years of age, are premenopausal, or who currently have osteoporosis are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in bone mineral density of the lumbar spine. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes are the levels of cells and proteins in the blood that provide information about the health of bone, along with change in bone mineral density of the hip and forearm. | 2 years |
Countries
United Kingdom
Outcome results
None listed