Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer
- Registration Number
- NCT00088010
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this trial is to study:
* Effects of arzoxifene on bone fractures and bone mass.
* Effects of arzoxifene on getting breast cancer.
* Effects of arzoxifene on certain types of cardiovascular events, such as heart attack and stroke.
* Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health.
* Effects of arzoxifene on the uterus.
* The safety of arzoxifene and any side effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 9369
Inclusion Criteria
- 60-85 years of age
- Female
- At least two years since last menstrual cycle
Exclusion Criteria
- Abnormal or unexplained vaginal bleeding.
- Bone disorders, other than osteoporosis or low bone mass
- History of breast cancer, cancer of the uterus, or any cancer in the last five years (except skin cancer).
- History of cerebral vascular accidents or venous thromboembolic events
- Medications outlined
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo - 1 Arzoxifene -
- Primary Outcome Measures
Name Time Method Effects of arzoxifene on bone fractures and bone mass 5 years Effects of arzoxifene on getting breast cancer 5 years The safety of arzoxifene and any side effects 5 years
- Secondary Outcome Measures
Name Time Method Effects of arzoxifene on certain types of cardiovascular events 5 years Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health 5 years Effects of arzoxifene on the uterus 5 years Effects of arzoxifene on cognition 5 years Effects of arzoxifene on back pain 5 years
Trial Locations
- Locations (1)
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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇺🇸Elk Grove, Illinois, United States