Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer

Effects of Arzoxifene on Vertebral Fracture Incidence and on Invasive Breast Cancer Incidence in Postmenopausal Women With Osteoporosis or With Low Bone Density.

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.

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