Osteoporosis, Postmenopausal
Conditions
Brief summary
The purpose of this study is to compare the effect of arzoxifene to raloxifene on the bone mineral density (bone strength).
Interventions
DRUGArzoxifene
20 mg, oral, tablet, once a day for 52 weeks
DRUGRaloxifene
60 mg, oral, tablet, once a day for 52 weeks
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Must have osteoporosis * Must be between 50 and 75 years old and be able to walk * Have at least two of your back bones that can be x-rayed * Have not had a period in at least two years * Be willing to have blood tests
Exclusion criteria
* Have a bone disease other than osteoporosis * History of estrogen dependent cancer * History of stroke or certain heart problems * Possibly have an allergy to raloxifene or arzoxifene * Have certain abnormal lab values * History of seizure disorder * Have unexplained vaginal bleeding or an abnormal pap smear
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in Lumbar Spine BMD | baseline to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Secondary BMD measures of total hip and femoral neck | at 6 and 12 months |
| Biochemical markers of bone metabolism assessed | baseline, 3, 6, and 12 months |
| Assessment of coagulation parameters | baseline, 3, 6, and 12 months |
| Breast Density by mammogram | screening and 12 months |
Countries
Argentina, Australia, Canada, France, Italy, Spain, Taiwan, United States
Outcome results
None listed