- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00462683
Bone Loss, Fractures, and Management of Bone Health in People With Stroke in Managed Rehabilitation Settings
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Primary Outcomes: As this study has no control or comparator group, the goal will be to provide descriptive data regarding the prevalence of osteopenia and osteoporosis at each of the anatomic sites evaluated by DEXA in this specialized population (BMD outcome measures). Additionally, the use of bone-specific interventions (vitamins, nutritional supplements, medications), previous diagnostic testing (DEXA) and history of falls and fractures will be assessed to determine the extent to which bone health has been considered and evaluated in this population of individuals at increased risk of fracture.
Secondary Outcomes: Functional status measures will also be obtained to enable correlation with bone data.
This study involves a cross-sectional, descriptive evaluation of a cohort of 225 patients with brain injury who are being managed at the out-patient clinics by physicians from RIC. The goal of the study is to provide representative data of both the general bone health of this population of patients (degree, extent and localization of bone loss) as well as interventions that may have been implemented to manage their bone health (vitamins, nutritional supplements, prescription medications). After obtaining informed consent, those patients who wish to be involved will be asked to complete a medical history questionnaire that focuses on bone health and will then undergo measurement of bone density by DEXA (dual energy X-ray absorptiometry). At the time of the DEXA examination, muscle strength will be evaluated by a trained research coordinator. A dietary history and a blood sample will also be obtained, the latter for storage in order to later measure vitamin D levels and/or other bone markers. All subjects will then be given the opportunity to continue in the longitudinal arm of the study (second phase). Those who do will sign the informed consent and will then be re-evaluated at yearly intervals with the same set of data being obtained.
Descriptive Data to be Obtained:
- Demographics: date of birth, sex, race, ethnicity
Detailed and complete medical history, with particular focus on:
- Information regarding brain injury: time of occurrence, motor/sensory, etc.
- Bone specific information: history of falls, fractures, use of medications, smoking, alcohol, family history of osteoporosis and fractures, previous DEXA, etc.
- Questionnaire of functional status: use of affected arm, ambulation, assistive device, orthotic, frequency of spasms.
- Evaluation of motor status using the Motor Components of the NIH Stroke Scale (items 4 - 7)
- Dietary history
Study procedures:
1. DEXA evaluation. Specific measurements will be made for lumbar spine, hip and distal radius; lateral vertebral assessment will be obtained if possible.
Biological Samples:
1. Two 10ml tubes of blood will be obtained from each participant. Serum will be separated and frozen in two aliquots to be saved for possible measurement of vitamin D levels (25OH vitamin D) and/or bone markers.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Chicago, Illinois, Estados Unidos, 60611
- Rehabilitation Institute of Chicago
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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:
- History of brain injury at some defined time in the past (include stroke, traumatic brain injury, anoxia)
- Age 16 years and older (no upper age limit)
- Male and females
- Able to undergo a DEXA examination (able to lie on the DEXA table for 20-30 minutes)
- Able to provide answers to the questionnaires regarding medical and dietary history and demographics
- Able to provide informed consent
Exclusion Criteria:
- History of spinal cord injury
- History of traumatic brain damage
- Inability to lie down appropriately to obtain DEXA measurements
- Inability to communicate
- Anything condition that in the judgment of the physician would prevent the person from participating
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Thomas J Schnitzer, MD, PhD, Northwestern Univesity & Rehabilitation Institute of Chicago
- Investigador principal: Richard Harvey, MD, PhD, Shirley Ryan AbilityLab
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
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Trauma craneoencefálico
- Trauma, Sistema Nervioso
- Signos y Síntomas Respiratorios
- Carrera
- Lesiones Cerebrales
- Hipoxia
Otros números de identificación del estudio
- NURIC0445100
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