- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01934387
Geriatric Health Exam Osteoporosis Screening
Increasing Osteoporosis Awareness With Fracture Risk Assessments and Management Among Geriatric Health Examination Recipients at National Taiwan University Hospital
BACKGROUND: The World Health Organization Fracture Risk Assessment Tool (WHO FRAX®) Taiwanese calculator is freely available on line to help osteoporosis management. However, its clinical utility for improving osteoporosis awareness and patient acceptance has not been validated in Taiwanese population.
OBJECTIVES: This 11-month FRAX® based screening and referral program enrolling older adults participating in the geriatric health examinations (GHEs) at the National Taiwan University Hospital (NTUH) aiming at determine the patient acceptance of the tool and the program and to improve patient awareness in osteoporosis. The second aim is to look for the recommendations from the participating physicians to improve the FRAX® -based osteoporosis management model.
METHODS: The NTUH GHE program is a two stage process to serve 3,000 older adults collecting annually from Mar. to Dec. Subjects will be enrolled to the current study at the stage 1 GHE visits after informed consent. Baseline questionnaires including the FRAX® tools will be distributed and expected to be returned at the stage 2 visits. Research assistants will calculate the 10-year predicted fracture risks for the participants during the waiting periods and present the numbers to the GHE physicians. High risks individuals will be referred to general geriatric clinic for further managements. All participants will be provided with osteoporosis and fracture educational material. Patient acceptance and awareness will be assessed. The study is to be started from Feb., to Oct., 2013 to enroll roughly 1,800 older adults assuming refusal rate about 40%.
Qualitative interviews will be used to obtain recommendations from study geriatricians in Jul., 2013 to optimize the FRAX® based screening and management model.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
ANTICIPATED RESULTS:
To estimate the 10 year fracture risks for GHE participants. To understand the acceptance of this FRAX® based model from GHE participants and the impacts on patient osteoporosis awareness.
To calculate the economic benefits of this model on geriatric outpatient service.
To obtain recommendations from study geriatricians to optimize the FRAX® based model for further disseminations.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Taipei, Taiwán, 100
- National Taiwan University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Participation in the NTUH GHE program
- Can complete the study questionnaire
- Willingness to join in the researchers
Exclusion Criteria:
- NA
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentages of elderly transfer to geriatric department
Periodo de tiempo: 11-month
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The study expected to collect 1,800 cases that using the assessment tool (FRAX) for osteoporosis screening.
The primary outcomes were 10-year probability of major osteoporotic fracture and 10-year probability of hip fracture.Investigators want to know what the percentages of elderly in high risk need to be transfer to geriatric department for further treatment.
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11-month
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ding-Cheng Chan, MD, PhD, National Taiwan University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 201205110RIC
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AmgenTerminadoOsteoporosis posmenopáusica (OPM)Japón
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Appalachian State UniversityNorth Carolina Agriculture & Technical State UniversityTerminadoOsteoporosis posmenopáusica | Osteoporosis, OsteopeniaEstados Unidos
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Deltanoid PharmaceuticalsTerminadoOsteoporosis posmenopáusica, sitios múltiples
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Radius Health, Inc.TerminadoOsteoporosis | Osteoporosis relacionada con la edad | Osteoporosis relacionada con la edad | Osteoporosis localizada en la columna vertebral | Osteoporosis senil | Osteoporosis de vértebrasEstados Unidos, Polonia, Italia
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Organon and CoTerminadoOsteoporosis posmenopáusica
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AmgenTerminadoOsteoporosis posmenopáusicaEstados Unidos, Canadá, Dinamarca, Alemania, Bélgica, Colombia, Chequia, Japón, México, Polonia, Suiza, Hungría, España, Australia, Rumania, Reino Unido, India, Argentina, Brasil, República Dominicana, Estonia, Letonia, Lituania, Nueva Zelanda
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Penn State UniversityCalifornia Dried Plum BoardActivo, no reclutando
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Massachusetts General HospitalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)TerminadoOsteoporosis posmenopáusicaEstados Unidos
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Sahlgrenska University Hospital, SwedenBioGaia ABTerminadoOsteoporosis posmenopáusicaSuecia