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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00035971
Other study ID # 5548
Secondary ID H3S-US-GGKO
Status Completed
Phase Phase 4
First received May 7, 2002
Last updated July 18, 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 determine how treatment with raloxifene compares to treatment with alendronate in postmenopausal women with osteoporosis on the chance of experiencing fractures


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria

- 50-80 years of age, inclusive

- 2 years since last menses

- Dx femoral neck osteoporosis

- No vertebral fractures

Exclusion Criteria

- Poor candidate for study drugs

- Hx of diseases affecting bone metabolism

- Hx of breast/estrogen-dependent cancer

- Current use of osteoporosis drug therapy

- Hx/high risk of VTE

Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
raloxifene HCI and alendronate Na


Locations

Country Name City State
Canada 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. Burlington Ontario
Canada 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. Calgary Alberta
Canada 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. Hamilton Ontario
Canada 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. Kitchener Ontario
Canada 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. Moncton New Brunswick
Canada 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. Montreal Quebec
Canada 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. Ottawa Ontario
Canada 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. Sainte Foy Quebec
Canada 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. Saskatoon Saskatchewan
Canada 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. Sudbury Ontario
Canada 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. Trois-Rivieres Quebec
Canada 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. Vancouver British Columbia
Canada 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. Winnipeg Manitoba
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. Albany New York
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. Albuquerque New Mexico
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. Anniston Alabama
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. Austin 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. Bangor Maine
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. Beachwood 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. Beverly Hills 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. Boise Idaho
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. Boston Massachusetts
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. Bronx New York
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. Burlington Vermont
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. Canton 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. Charlotte North Carolina
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. Charlottesville Virginia
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. Cincinnati 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. Decatur Georgia
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. Des Moines 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. Detroit Michigan
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. Evansville Indiana
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. Fayetteville Georgia
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. Frederick 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. Gainesville Georgia
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. Greensboro North Carolina
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. Greenville North Carolina
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. Honolulu Hawaii
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. Idaho Falls Idaho
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. Indianapolis Indiana
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. Johnston Rhode Island
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. Lakewood Colorado
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. Lebanon New Hampshire
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. Lexington Kentucky
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. Loma Linda 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. Madison Wisconsin
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. Maitland 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. Miami 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. Minneapolis Minnesota
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. Morehead City North Carolina
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. Morton Grove 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. New York New York
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. Newport News Virginia
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. Omaha Nebraska
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. Overland Park Kansas
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. Passaic New Jersey
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. Peoria 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. Philadelphia 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. Phoenix Arizona
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. Pittsburgh 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. 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. Providence Rhode Island
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. Richmond Virginia
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. Riverdale Georgia
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. Rochester New York
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. Salt Lake City Utah
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. San Antonio 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. San Francisco 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. Scottsdale Arizona
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. Seattle Washington
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. Spokane Washington
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. Springfield Missouri
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. St. Louis Missouri
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. Tacoma Washington
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. Tampa 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. Temple 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. Trumbull Connecticut
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. Tucson Arizona
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. Tulsa 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. Walnut Creek 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. West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada, 

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