- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00035971
EVA: Srovnání Evista Alendronate
18. července 2006 aktualizováno: Eli Lilly and Company
Účelem této studie je zjistit, jak je léčba raloxifenem srovnatelná s léčbou alendronátem u postmenopauzálních žen s osteoporózou, pokud jde o možnost výskytu zlomenin
Přehled studie
Typ studie
Intervenční
Fáze
- Fáze 4
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Alberta
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Calgary, Alberta, Kanada
- 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.
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British Columbia
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Vancouver, British Columbia, Kanada
- 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.
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Manitoba
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Winnipeg, Manitoba, Kanada
- 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.
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New Brunswick
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Moncton, New Brunswick, Kanada
- 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.
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Ontario
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Burlington, Ontario, Kanada
- 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.
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Hamilton, Ontario, Kanada
- 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.
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Kitchener, Ontario, Kanada
- 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.
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Ottawa, Ontario, Kanada
- 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.
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Sudbury, Ontario, Kanada
- 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.
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Quebec
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Montreal, Quebec, Kanada
- 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.
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Sainte Foy, Quebec, Kanada
- 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.
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Trois-Rivieres, Quebec, Kanada
- 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.
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada
- 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.
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Alabama
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Anniston, Alabama, Spojené státy
- 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.
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Arizona
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Phoenix, Arizona, Spojené státy
- 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.
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Scottsdale, Arizona, Spojené státy
- 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.
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Tucson, Arizona, Spojené státy
- 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.
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California
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Anaheim, California, Spojené státy
- 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.
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Beverly Hills, California, Spojené státy
- 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.
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Loma Linda, California, Spojené státy
- 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.
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Oakland, California, Spojené státy
- 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.
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San Francisco, California, Spojené státy
- 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.
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Walnut Creek, California, Spojené státy
- 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.
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Colorado
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Lakewood, Colorado, Spojené státy
- 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.
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Connecticut
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Trumbull, Connecticut, Spojené státy
- 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.
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Florida
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Maitland, Florida, Spojené státy
- 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.
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Miami, Florida, Spojené státy
- 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.
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Tampa, Florida, Spojené státy
- 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.
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West Palm Beach, Florida, Spojené státy
- 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.
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Georgia
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Decatur, Georgia, Spojené státy
- 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.
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Fayetteville, Georgia, Spojené státy
- 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.
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Gainesville, Georgia, Spojené státy
- 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.
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Riverdale, Georgia, Spojené státy
- 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.
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Hawaii
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Honolulu, Hawaii, Spojené státy
- 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.
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Idaho
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Boise, Idaho, Spojené státy
- 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.
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Idaho Falls, Idaho, Spojené státy
- 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.
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Illinois
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Chicago, Illinois, Spojené státy
- 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.
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Morton Grove, Illinois, Spojené státy
- 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.
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Peoria, Illinois, Spojené státy
- 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.
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Indiana
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Evansville, Indiana, Spojené státy
- 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.
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Indianapolis, Indiana, Spojené státy
- 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.
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Iowa
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Des Moines, Iowa, Spojené státy
- 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.
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Kansas
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Overland Park, Kansas, Spojené státy
- 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.
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Kentucky
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Lexington, Kentucky, Spojené státy
- 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.
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Maine
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Bangor, Maine, Spojené státy
- 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.
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Maryland
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Frederick, Maryland, Spojené státy
- 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.
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Hagerstown, Maryland, Spojené státy
- 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.
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Massachusetts
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Boston, Massachusetts, Spojené státy
- 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.
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Michigan
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Detroit, Michigan, Spojené státy
- 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.
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Minnesota
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Minneapolis, Minnesota, Spojené státy
- 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.
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Missouri
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Springfield, Missouri, Spojené státy
- 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.
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St. Louis, Missouri, Spojené státy
- 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.
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Nebraska
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Omaha, Nebraska, Spojené státy
- 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.
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New Hampshire
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Lebanon, New Hampshire, Spojené státy
- 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.
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New Jersey
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Passaic, New Jersey, Spojené státy
- 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.
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New Mexico
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Albuquerque, New Mexico, Spojené státy
- 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.
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New York
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Albany, New York, Spojené státy
- 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.
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Bronx, New York, Spojené státy
- 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.
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New York, New York, Spojené státy
- 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.
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Rochester, New York, Spojené státy
- 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.
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North Carolina
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Charlotte, North Carolina, Spojené státy
- 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.
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Greensboro, North Carolina, Spojené státy
- 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.
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Greenville, North Carolina, Spojené státy
- 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.
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Morehead City, North Carolina, Spojené státy
- 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.
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Ohio
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Beachwood, Ohio, Spojené státy
- 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.
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Canton, Ohio, Spojené státy
- 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.
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Cincinnati, Ohio, Spojené státy
- 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.
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Oklahoma
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Tulsa, Oklahoma, Spojené státy
- 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.
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Oregon
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Portland, Oregon, Spojené státy
- 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.
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy
- 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.
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Pittsburgh, Pennsylvania, Spojené státy
- 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.
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Rhode Island
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Johnston, Rhode Island, Spojené státy
- 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.
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Providence, Rhode Island, Spojené státy
- 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.
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Texas
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Austin, Texas, Spojené státy
- 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.
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Dallas, Texas, Spojené státy
- 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.
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San Antonio, Texas, Spojené státy
- 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.
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Temple, Texas, Spojené státy
- 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.
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Utah
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Salt Lake City, Utah, Spojené státy
- 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.
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Vermont
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Burlington, Vermont, Spojené státy
- 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.
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Virginia
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Charlottesville, Virginia, Spojené státy
- 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.
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Newport News, Virginia, Spojené státy
- 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.
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Richmond, Virginia, Spojené státy
- 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.
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Washington
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Seattle, Washington, Spojené státy
- 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.
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Spokane, Washington, Spojené státy
- 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.
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Tacoma, Washington, Spojené státy
- 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.
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Wisconsin
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Madison, Wisconsin, Spojené státy
- 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.
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
50 let až 80 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
Kritéria pro zařazení
- 50-80 let včetně
- 2 roky od poslední menstruace
- Dx osteoporóza krčku stehenní kosti
- Žádné zlomeniny obratlů
Kritéria vyloučení
- Špatný kandidát na studijní drogy
- Hx onemocnění ovlivňujících metabolismus kostí
- Hx rakoviny prsu/estrogen-dependentní rakoviny
- Současné využití lékové terapie osteoporózy
- Hx/vysoké riziko VTE
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
6. prosince 2022
Primární dokončení
6. prosince 2022
Dokončení studie
6. prosince 2022
Termíny zápisu do studia
První předloženo
7. května 2002
První předloženo, které splnilo kritéria kontroly kvality
7. května 2002
První zveřejněno (Odhad)
8. května 2002
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
19. července 2006
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. července 2006
Naposledy ověřeno
1. července 2006
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Metabolické choroby
- Nemoci pohybového aparátu
- Nemoci kostí
- Nemoci kostí, Metabolické
- Osteoporóza
- Fyziologické účinky léků
- Hormony, hormonální náhražky a antagonisté hormonů
- Antagonisté hormonů
- Činidla pro zachování hustoty kostí
- Antagonisté estrogenu
- Selektivní modulátory estrogenových receptorů
- Modulátory estrogenových receptorů
- Alendronát
- Raloxifen hydrochlorid
Další identifikační čísla studie
- 5548
- H3S-US-GGKO
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .