Effects of Arzoxifene on Bone Mass and the Uterus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Postmenopausal Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Arzoxifene

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes