Effects of Arzoxifene on Bone Mass and the Uterus

March 7, 2007 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion

February 1, 2007

Study Registration Dates

First Submitted

June 18, 2004

First Submitted That Met QC Criteria

June 21, 2004

First Posted (Estimate)

June 22, 2004

Study Record Updates

Last Update Posted (Estimate)

March 9, 2007

Last Update Submitted That Met QC Criteria

March 7, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8537 (CTEP)
  • H4Z-MC-GJAE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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