Effects of Arzoxifene on Bone Mass and the Uterus
Completed · Phase 3 · Has a placebo group
Conditions studied: Postmenopausal Bone Loss
In brief
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.
Key facts
- Study ID
- NCT00085956
- Run by
- Eli Lilly and Company
- People needed
- 300
- Starts
- 2004-04-01
- Expected to finish
- 2007-02-01
- Last updated by the study team
- 2007-03-09
Who can join
Age: 45 and older, up to 60. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Female
- 45 to 60 years of age, inclusive
- At least 2 years since last menstrual cycle
- Intact uterus (womb).
You may not qualify if…
- 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.
Where it is running
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — San Diego, California, United States
Full record on ClinicalTrials.gov
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