Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis

Verified by: Eli Lilly and Company, January 2010
First Received: September 29, 2006 | Last Updated: January 26, 2010 | Phase: Phase 3 | Start Date: October 2006
Overall Status: Completed | Estimated Enrollment: 320
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The purpose of this study is to compare the effect of arzoxifene to raloxifene on the bone mineral density (bone strength)...

Brief Summary

Official Title: “The Comparison of the Efficacy and Safety of Arzoxifene Versus Raloxifene in Postmenopausal Women With Osteoporosis”

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

  • Drug: Arzoxifene
    • 20 mg, oral, tablet, once a day for 52 weeks
  • Drug: Raloxifene
    • 60 mg, oral, tablet, once a day for 52 weeks

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
  • Active Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • Percent change in Lumbar Spine BMD
    • Time Frame: baseline to 12 months
      Safety Issue?: No

Secondary Measures

  • Secondary BMD measures of total hip and femoral neck
    • Time Frame: at 6 and 12 months
      Safety Issue?: No
  • Biochemical markers of bone metabolism assessed
    • Time Frame: baseline, 3, 6, and 12 months
      Safety Issue?: No
  • Assessment of coagulation parameters
    • Time Frame: baseline, 3, 6, and 12 months
      Safety Issue?: No
  • Breast Density by mammogram
    • Time Frame: screening and 12 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • 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 Criteria:

  • 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00383422

Study ID Number: 8580

ClinicalTrials.gov Identifier: NCT00383422

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry

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