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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00462683
Bone Loss, Fractures, and Management of Bone Health in People With Stroke in Managed Rehabilitation Settings
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NURIC0445100
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