Completed

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

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What is being tested

Data Collection

Who is being recruted

Bone Diseases+3

+ Bone Diseases, Metabolic

+ Metabolic Diseases

From 45 to 60 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: April 2004
See protocol details

Summary

Principal SponsorEli Lilly and Company
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleEffects of Arzoxifene on Bone Mineral Density and Endometrial Histology in Postmenopausal Women. 
NCT00085956
Principal SponsorEli Lilly and Company
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 45 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesBone Diseases, MetabolicMetabolic DiseasesMusculoskeletal DiseasesOsteoporosisOsteoporosis, Postmenopausal

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

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, United StatesSee the location
CompletedOne Study Center