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Effects of Arzoxifene on Bone Mass and the Uterus

Primary Purpose

Postmenopausal Bone Loss

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Arzoxifene
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postmenopausal Bone Loss

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleAccepts 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.

Sites / Locations

  • 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.

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
June 18, 2004
Last Updated
March 7, 2007
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00085956
Brief Title
Effects of Arzoxifene on Bone Mass and the Uterus
Official Title
Effects of Arzoxifene on Bone Mineral Density and Endometrial Histology in Postmenopausal Women.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Bone Loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Arzoxifene
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women
Title
The effects of arzoxifene on the uterus (womb) in post menopausal women
Title
The safety of arzoxifene and any side effects that might be associated with its use
Secondary Outcome Measure Information:
Title
The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density
Title
The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease
Title
The effects of arzoxifene on breast density

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

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