Clinical Trials Directory

Trials / Completed

CompletedNCT00088010

Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
9,369 (actual)
Sponsor
Eli Lilly and Company · Industry
Sex
Female
Age
60 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGArzoxifene20mg, oral, tablet, once a day for 36 months
DRUGPlacebooral, tablet, once a day for 36 months

Timeline

Start date
2004-06-01
Primary completion
2009-06-01
Completion
2009-11-01
First posted
2004-07-20
Last updated
2010-06-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00088010. Inclusion in this directory is not an endorsement.