Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer
NCT00088010 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9369
Last updated 2010-06-02
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.
Conditions
- Osteoporosis, Postmenopausal
Interventions
- DRUG
-
Arzoxifene
20mg, oral, tablet, once a day for 36 months
- DRUG
-
oral, tablet, once a day for 36 months
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
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) · Eli Lilly and Company
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 85 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-06-30
- Primary Completion
- 2009-06-30
- Completion
- 2009-11-30
Countries
- United States
Study Locations
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