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Clinical Trials/NCT00085956
NCT00085956
Completed
Phase 3

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

Eli Lilly and Company1 site in 1 country300 target enrollmentStarted: April 2004Last updated:
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ConditionsPostmenopausal Bone Loss
DrugsArzoxifenePlacebo

Overview

Phase
Phase 3
Status
Completed
Enrollment
300
Locations
1
Primary Endpoint
The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double

Eligibility Criteria

Ages
45 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Outcomes

Primary Outcomes

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 Outcomes

  • 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

Investigators

Sponsor Class
Industry

Study Sites (1)

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