Effects of Arzoxifene on Bone Mass and the Uterus

Phase 3

Completed

• Conditions: Postmenopausal Bone Loss

• Registration Number: NCT00085956
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2004-06-18
• Study First Submitted QC: 2004-06-21
• Study First Posted: 2004-06-22
• Study Completion: 2007-02
• Status Verified: 2007-03
• Last Update Submitted: 2007-03-07
• Last Update Posted: 2007-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 post menopausal women
The safety of arzoxifene and any side effects that might be associated with its use

Secondary Outcome Measures

Name	Time	Method
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
The effects of arzoxifene on breast density

Trial Locations

Locations (1)

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 to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇺🇸 San Diego, California, United States