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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00046137
Other study ID # 6817
Secondary ID B3D-MC-GHCD
Status Completed
Phase Phase 3
First received September 20, 2002
Last updated July 19, 2006

Study information

Verified date July 2006
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 85 Years
Eligibility 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 Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
teriparatide

raloxifene

placebo


Locations

Country Name City State
United States "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 "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 "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 "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 "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 "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 "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 "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 "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 "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 "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 "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 "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

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

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