Effects of Arzoxifene on Vertebral Fracture Incidence and on Invasive Breast Cancer Incidence in Postmenopausal Women With Osteoporosis or With Low Bone Density.
Phase 3
60 Years
85 Years
60 Years
85 Years
Not Enrolling
Female
Osteoporosis, Postmenopausal
Female
Osteoporosis, Postmenopausal
Trial Information
Effects of Arzoxifene on Vertebral Fracture Incidence and on Invasive Breast Cancer Incidence in Postmenopausal Women With Osteoporosis or With Low Bone Density.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Effects of arzoxifene on bone fractures and bone mass
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
United States: Food and Drug Administration
Study ID:
8536
NCT ID:
NCT00088010
Start Date:
June 2004
Completion Date:
November 2009
Related Keywords:
- Osteoporosis, Postmenopausal
- Breast Neoplasms
- Osteoporosis
- Osteoporosis, Postmenopausal
Name | Location |
|---|---|
| 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 60007 |
