Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

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