- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01768598
Risk Taking and Fracture Study
An Investigation Into Risk Taking Behaviour, Bone Microstructure and Fracture Between the Sexes: What Underpins Fracture in Boys Compared to Girls During Growth?
Boys suffer a disproportionately large number of fractures compared to girls (55-60%). This study aims to determine why this is the case by identifying risk factors for wrist fractures. The increase in fracture during childhood and adolescence may be associated with 1) risk-taking behaviour in boys, 2) obesity trends in boys during childhood and adolescence, and/or 3) impaired acquisition of bone strength during childhood and adolescence. Importantly from a knowledge translation perspective, modifiable factors such as behaviour, dietary habits or physical activity in boys may predict fracture.
The investigators will measure 400 children (100 girls and 100 boys who have sustained a fracture; 100 same age and sex friends) across 4 years of growth. This study will assess risk behaviours, diet, physical activity, motor proficiency (i.e., balance and coordination), fat and muscle mass and bone strength to determine if there are, 1) differences in whether all or some of these factors predict fractures in boys compared with girls and, 2) whether these factors track forward similarly in boys compared with girls as children advance through the growth spurt.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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British Columbia
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Vancouver, British Columbia, Canadá, V6H 3V4
- British Columbia Children's Hospital
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Vancouver, British Columbia, Canadá, V5Z 1M9
- Centre for Hip Health and Mobility
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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
Fracture patients will be recruited from the orthopaedic clinic at BC Children's Hospital.
Non-fracture subjects will be recruited from the community
Descripción
Inclusion Criteria:
- Boys aged 9-15 and Girls aged 8-13
- Fracture to distal radius after low to moderate energy trauma
- No other health concerns
- Healthy (non fracture) subjects for comparison
Exclusion Criteria:
- Fracture is a result of severe trauma
- Children with ontological medical conditions
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Fracture - Boys
Boys who have sustained a distal radius fracture
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Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
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Fracture - Girls
Girls who have sustained a distal radius fracture
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Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
|
|
Non Fracture - Boys
Boys who have not sustained a distal radius fracture
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Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
|
|
Non Fracture - Girls
Girls who have not sustained a distal radius fracture
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Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Characterization of factors that contribute to fractures in boys and girls
Periodo de tiempo: Baseline (<3 months after injury)
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The factors include:
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Baseline (<3 months after injury)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Tracking of Risk Factors
Periodo de tiempo: 4 years
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The outcomes will be measured across a 3 year interval (4 years in total) to determine whether factors track similarly in boys compared with girls over time and to assess their continued (or not) contribution to fracture.
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4 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Heather McKay, PhD, Centre for Hip Health and Mobility
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
- H10-00044
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