Postmenopausal Bone Loss
Conditions
Brief summary
The purposes of this study are to determine: * The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women. * The effects of arzoxifene on the uterus (womb) in postmenopausal women. * The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density. * The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease risk. * The safety of arzoxifene and any side effects that might be associated with its use.
Interventions
DRUGArzoxifene
DRUGPlacebo
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Female * 45 to 60 years of age, inclusive * At least 2 years since last menstrual cycle * Intact uterus (womb).
Exclusion criteria
* Existing fracture of the spine. * Bone disorders, other than low bone mass * History of cancer in the last 5 years. Also, any history, at any time, of breast cancer or cancer of the lining of the uterus. * Abnormal or unexplained vaginal bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women | — |
| The effects of arzoxifene on the uterus (womb) in post menopausal women | — |
| The safety of arzoxifene and any side effects that might be associated with its use | — |
Secondary
| Measure | Time frame |
|---|---|
| The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density | — |
| The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease | — |
| The effects of arzoxifene on breast density | — |
Countries
United States
Outcome results
None listed