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Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00046137
Collaborator
(none)
13
Locations

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 85 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 "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". Anaheim California United States 92801
    2 "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
    3 "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". Altamonte Springs Florida United States 32714
    4 "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". Chicago Illinois United States 60622
    5 "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". Cedar Rapids Iowa United States 52401
    6 "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". Baltimore Maryland United States 21204
    7 "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
    8 "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". Voorhees New Jersey United States 08043
    9 "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". Cleveland Ohio United States 44195
    10 "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 City Oklahoma United States 73109
    11 "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". Portland Oregon United States 97213
    12 "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". Duncansville Pennsylvania United States 16635
    13 "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". Dallas Texas United States 75231

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00046137
    Other Study ID Numbers:
    • 6817
    • B3D-MC-GHCD
    First Posted:
    Sep 23, 2002
    Last Update Posted:
    Jul 20, 2006
    Last Verified:
    Jul 1, 2006
    Additional relevant MeSH terms:
    Osteoporosis
    Osteoporosis, Postmenopausal
    Teriparatide
    Raloxifene Hydrochloride

    Study Results

    No Results Posted as of Jul 20, 2006