Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis

NCT ID: NCT00046137

Last Updated: 2006-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoporosis, Postmenopausal

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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teriparatide

Intervention Type DRUG

raloxifene

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

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"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

Site Status

"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

Site Status

"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

Site Status

"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

Site Status

"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

Site Status

"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

Site Status

"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

Site Status

"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 Township, New Jersey, United States

Site Status

"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

Site Status

"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

Site Status

"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

Site Status

"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

Site Status

"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

Site Status

Countries

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United States

Other Identifiers

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B3D-MC-GHCD

Identifier Type: -

Identifier Source: secondary_id

6817

Identifier Type: -

Identifier Source: org_study_id