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Comparación de EVA: Evista alendronato

18 de julio de 2006 actualizado por: Eli Lilly and Company

El propósito de este estudio es determinar cómo se compara el tratamiento con raloxifeno con el tratamiento con alendronato en mujeres posmenopáusicas con osteoporosis en cuanto a la posibilidad de sufrir fracturas.

Descripción general del estudio

Estado

Terminado

Condiciones

Osteoporosis

Intervención / Tratamiento

Droga: raloxifeno HCl y alendronato Na

Tipo de estudio

Intervencionista

Fase

Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Canadá
- Alberta
  - Calgary, Alberta, Canadá
    - For additional information regarding investigative 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, Canadá
    - For additional information regarding investigative 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, Canadá
    - For additional information regarding investigative 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, Canadá
    - For additional information regarding investigative 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, Canadá
    - For additional information regarding investigative 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, Canadá
    - For additional information regarding investigative 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, Canadá
    - For additional information regarding investigative 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, Canadá
    - For additional information regarding investigative 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, Canadá
    - For additional information regarding investigative 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, Canadá
    - For additional information regarding investigative 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, Canadá
    - For additional information regarding investigative 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, Canadá
    - For additional information regarding investigative 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, Canadá
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Estados Unidos
- Alabama
  - Anniston, Alabama, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative 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, Estados Unidos
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

50 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Descripción

Criterios de inclusión

50-80 años de edad, inclusive
2 años desde la última menstruación
Osteoporosis del cuello femoral Dx
Sin fracturas vertebrales

Criterio de exclusión

Mal candidato para los fármacos del estudio
Historial de enfermedades que afectan el metabolismo óseo
Historial de cáncer de mama/dependiente de estrógenos
Uso actual de la terapia con medicamentos para la osteoporosis
Hx/alto riesgo de TEV

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Tratamiento

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Eli Lilly and Company

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

6 de diciembre de 2022

Finalización primaria

6 de diciembre de 2022

Finalización del estudio

6 de diciembre de 2022

Fechas de registro del estudio

Enviado por primera vez

7 de mayo de 2002

Primero enviado que cumplió con los criterios de control de calidad

7 de mayo de 2002

Publicado por primera vez (Estimar)

8 de mayo de 2002

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

19 de julio de 2006

Última actualización enviada que cumplió con los criterios de control de calidad

18 de julio de 2006

Última verificación

1 de julio de 2006

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

5548
H3S-US-GGKO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

producto fabricado y exportado desde los EE. UU.

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .