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Clinical Trials/NCT00088010
NCT00088010CompletedPhase 3

Effects of Arzoxifene on Vertebral Fracture Incidence and on Invasive Breast Cancer Incidence in Postmenopausal Women With Osteoporosis or With Low Bone Density.

Eli Lilly and Company1 site in 1 country9,369 target enrollmentStarted: June 2004Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
9,369
Locations
1
Primary Endpoint
Effects of arzoxifene on bone fractures and bone mass
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this trial is to study:

  • Effects of arzoxifene on bone fractures and bone mass.
  • Effects of arzoxifene on getting breast cancer.
  • Effects of arzoxifene on certain types of cardiovascular events, such as heart attack and stroke.
  • Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health.
  • Effects of arzoxifene on the uterus.
  • The safety of arzoxifene and any side effects.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to 85 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •60-85 years of age
  • •At least two years since last menstrual cycle

Exclusion Criteria

  • •Abnormal or unexplained vaginal bleeding.
  • •Bone disorders, other than osteoporosis or low bone mass
  • •History of breast cancer, cancer of the uterus, or any cancer in the last five years (except skin cancer).
  • •History of cerebral vascular accidents or venous thromboembolic events
  • •Medications outlined

Arms & Interventions

1

Experimental

Intervention: Arzoxifene (Drug)

2

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Effects of arzoxifene on bone fractures and bone mass

Time Frame: 5 years

Effects of arzoxifene on getting breast cancer

Time Frame: 5 years

The safety of arzoxifene and any side effects

Time Frame: 5 years

Secondary Outcomes

  • Effects of arzoxifene on certain types of cardiovascular events(5 years)
  • Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health(5 years)
  • Effects of arzoxifene on the uterus(5 years)
  • Effects of arzoxifene on cognition(5 years)
  • Effects of arzoxifene on back pain(5 years)

Investigators

Sponsor Class
Industry

Study Sites (1)

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Effects of Arzoxifene on Bone Fractures... | Clinical Trial