Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis

July 19, 2006 updated by: Eli Lilly and Company
The purpose of this study is to compare treatment with both teriparatide and raloxifene with teriparatide alone. The study will evaluate any side effects that may be associated with the two drugs and may help to determine whether teriparatide and raloxifene together can help patients with osteoporosis more than teriparatide alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
      • Oakland, California, United States, 94612
        • "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
    • Illinois
      • Chicago, Illinois, United States, 60622
        • "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
    • Iowa
      • Cedar Rapids, Iowa, United States, 52401
        • "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
      • Hagerstown, Maryland, United States, 21740
        • "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
    • Oregon
      • Portland, Oregon, United States, 97213
        • "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
    • Texas
      • Dallas, Texas, United States, 75231
        • "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  • Must be diagnosed with osteoporosis.
  • Must be female, age 45 through 85.
  • Must be at least 5 years postmenopausal.
  • Must be free of other severe or chronically disabling conditions.
  • Must be able to properly use injection device.

Exclusion Criteria

  • Must not have bone diseases other than osteoporosis.
  • Must not have history of certain cancers.
  • Must not have certain medical diseases (inflammatory bowel disease, malabsorption syndrome, kidney or bladder stones, venous thrombi or emboli, recent vaginal bleeding due to unknown causes).
  • Must not have taken or are currently taking certain types of medicines.
  • Must not have known allergy to the study agent or SERM.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 20, 2002

First Submitted That Met QC Criteria

September 20, 2002

First Posted (Estimate)

September 23, 2002

Study Record Updates

Last Update Posted (Estimate)

July 20, 2006

Last Update Submitted That Met QC Criteria

July 19, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6817
  • B3D-MC-GHCD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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