Effects of Arzoxifene on Bone Mass and the Uterus

Postmenopausal Bone Loss Clinical Trial

Official title:

Effects of Arzoxifene on Bone Mineral Density and Endometrial Histology in Postmenopausal Women.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00085956
• Other study ID #: 8537
• Secondary ID: H4Z-MC-GJAE
• Status: Completed
• Phase: Phase 3
• First received: June 18, 2004
• Last updated: March 7, 2007
• Start date: April 2004
• Est. completion date: February 2007

Study information

• Verified date: March 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis, Postmenopausal
• Postmenopausal Bone Loss

Intervention

Drug:
• Arzoxifene

• Placebo

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women
Primary	The effects of arzoxifene on the uterus (womb) in post menopausal women
Primary	The safety of arzoxifene and any side effects that might be associated with its use
Secondary	The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density
Secondary	The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease
Secondary	The effects of arzoxifene on breast density

External Links

•   Lilly Clinical Trial Registry