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EVA: porównanie alendronianu Evista

18 lipca 2006 zaktualizowane przez: Eli Lilly and Company

Celem tego badania jest określenie, jak leczenie raloksyfenem wypada w porównaniu z leczeniem alendronianem u kobiet po menopauzie z osteoporozą pod kątem ryzyka wystąpienia złamań

Przegląd badań

Status

Zakończony

Warunki

Osteoporoza

Interwencja / Leczenie

Lek: chlorowodorek raloksyfenu i alendronian Na

Typ studiów

Interwencyjne

Faza

Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Kanada
- Alberta
  - 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.
- British Columbia
  - 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.
- Manitoba
  - 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.
- New Brunswick
  - 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.
- Ontario
  - 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.
  - 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.
  - 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.
  - 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.
  - 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.
- Quebec
  - 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.
  - 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.
  - 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.
- Saskatchewan
  - 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.
Stany Zjednoczone
- Alabama
  - Anniston, Alabama, Stany Zjednoczone
    - 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.
- Arizona
  - Phoenix, Arizona, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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.
- California
  - Anaheim, California, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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.
- Colorado
  - Lakewood, Colorado, Stany Zjednoczone
    - 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.
- Connecticut
  - Trumbull, Connecticut, Stany Zjednoczone
    - 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.
- Florida
  - Maitland, Florida, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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.
- Georgia
  - Decatur, Georgia, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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.
- Hawaii
  - Honolulu, Hawaii, Stany Zjednoczone
    - 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
  - Boise, Idaho, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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.
- Illinois
  - Chicago, Illinois, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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.
- Indiana
  - Evansville, Indiana, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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.
- Iowa
  - Des Moines, Iowa, Stany Zjednoczone
    - 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.
- Kansas
  - Overland Park, Kansas, Stany Zjednoczone
    - 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.
- Kentucky
  - Lexington, Kentucky, Stany Zjednoczone
    - 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.
- Maine
  - Bangor, Maine, Stany Zjednoczone
    - 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.
- Maryland
  - Frederick, Maryland, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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.
- Massachusetts
  - Boston, Massachusetts, Stany Zjednoczone
    - 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.
- Michigan
  - Detroit, Michigan, Stany Zjednoczone
    - 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.
- Minnesota
  - Minneapolis, Minnesota, Stany Zjednoczone
    - 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.
- Missouri
  - Springfield, Missouri, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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.
- Nebraska
  - Omaha, Nebraska, Stany Zjednoczone
    - 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 Hampshire
  - Lebanon, New Hampshire, Stany Zjednoczone
    - 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 Jersey
  - Passaic, New Jersey, Stany Zjednoczone
    - 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 Mexico
  - Albuquerque, New Mexico, Stany Zjednoczone
    - 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
  - Albany, New York, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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.
- North Carolina
  - Charlotte, North Carolina, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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.
- Ohio
  - Beachwood, Ohio, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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
  - Tulsa, Oklahoma, Stany Zjednoczone
    - 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.
- Oregon
  - Portland, Oregon, Stany Zjednoczone
    - 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.
- Pennsylvania
  - Philadelphia, Pennsylvania, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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.
- Rhode Island
  - Johnston, Rhode Island, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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.
- Texas
  - Austin, Texas, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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.
- Utah
  - Salt Lake City, Utah, Stany Zjednoczone
    - 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.
- Vermont
  - Burlington, Vermont, Stany Zjednoczone
    - 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.
- Virginia
  - Charlottesville, Virginia, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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.
- Washington
  - Seattle, Washington, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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, Stany Zjednoczone
    - 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.
- Wisconsin
  - Madison, Wisconsin, Stany Zjednoczone
    - 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.

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

50 lat do 80 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

Kryteria przyjęcia

50-80 lat włącznie
2 lata od ostatniej miesiączki
Dx osteoporoza szyjki kości udowej
Brak złamań kręgów

Kryteria wyłączenia

Słaby kandydat na badane leki
Hx chorób wpływających na metabolizm kostny
Hx raka piersi/estrogenozależnego
Aktualne zastosowanie terapii lekowej osteoporozy
Hx/wysokie ryzyko ŻChZZ

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Główny cel: Leczenie

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Eli Lilly and Company

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Recker RR, Kendler D, Recknor CP, Rooney TW, Lewiecki EM, Utian WH, Cauley JA, Lorraine J, Qu Y, Kulkarni PM, Gaich CL, Wong M, Plouffe L Jr, Stock JL. Comparative effects of raloxifene and alendronate on fracture outcomes in postmenopausal women with low bone mass. Bone. 2007 Apr;40(4):843-51. doi: 10.1016/j.bone.2006.11.001. Epub 2006 Dec 19.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

6 grudnia 2022

Zakończenie podstawowe

6 grudnia 2022

Ukończenie studiów

6 grudnia 2022

Daty rejestracji na studia

Pierwszy przesłany

7 maja 2002

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 maja 2002

Pierwszy wysłany (Oszacować)

8 maja 2002

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

19 lipca 2006

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 lipca 2006

Ostatnia weryfikacja

1 lipca 2006

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

5548
H3S-US-GGKO

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .