Effects of Arzoxifene on Bone Mass and the Uterus

Lilly

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Bone Loss

Treatments: Drug: Placebo; Drug: Arzoxifene

Study type: Interventional

Funder types: Industry

Identifiers

NCT00085956

8537

H4Z-MC-GJAE

Details and patient eligibility

About

The purposes of this study are to determine:

• The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women.
• The effects of arzoxifene on the uterus (womb) in postmenopausal women.
• The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density.
• The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease risk.
• The safety of arzoxifene and any side effects that might be associated with its use.

Sex: Female

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female
• 45 to 60 years of age, inclusive
• At least 2 years since last menstrual cycle
• Intact uterus (womb).

Exclusion criteria

• Existing fracture of the spine.
• Bone disorders, other than low bone mass
• History of cancer in the last 5 years. Also, any history, at any time, of breast cancer or cancer of the lining of the uterus.
• Abnormal or unexplained vaginal bleeding.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind