Status:

COMPLETED

Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis

Lead Sponsor:

Eli Lilly and Company

Conditions:

Osteoporosis, Postmenopausal

Eligibility:

FEMALE

50-75 years

Phase:

PHASE3

Brief Summary

The purpose of this study is to compare the effect of arzoxifene to raloxifene on the bone mineral density (bone strength).

Eligibility Criteria

Inclusion

  • Must have osteoporosis
  • Must be between 50 and 75 years old and be able to walk
  • Have at least two of your back bones that can be x-rayed
  • Have not had a period in at least two years
  • Be willing to have blood tests

Exclusion

  • Have a bone disease other than osteoporosis
  • History of estrogen dependent cancer
  • History of stroke or certain heart problems
  • Possibly have an allergy to raloxifene or arzoxifene
  • Have certain abnormal lab values
  • History of seizure disorder
  • Have unexplained vaginal bleeding or an abnormal pap smear

Key Trial Info

Start Date :

October 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2008

Estimated Enrollment :

320 Patients enrolled

Trial Details

Trial ID

NCT00383422

Start Date

October 1 2006

End Date

July 1 2008

Last Update

January 28 2010

Active Locations (21)

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Page 1 of 6 (21 locations)

1

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Gainesville, Georgia, United States, 30501

2

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Urbandale, Iowa, United States, 50322

3

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Billings, Montana, United States, 59101

4

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Cincinnati, Ohio, United States, 45224