- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- British Columbia Children's Hospital
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Vancouver, British Columbia, Canada, V5Z 1M9
- Centre for Hip Health and Mobility
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Fracture patients will be recruited from the orthopaedic clinic at BC Children's Hospital.
Non-fracture subjects will be recruited from the community
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Fracture - Boys
Boys who have sustained a distal radius fracture
|
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
|
|
Fracture - Girls
Girls who have sustained a distal radius fracture
|
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
|
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
|
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Characterization of factors that contribute to fractures in boys and girls
Tidsramme: Baseline (<3 months after injury)
|
The factors include:
|
Baseline (<3 months after injury)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tracking of Risk Factors
Tidsramme: 4 years
|
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.
|
4 years
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Heather McKay, PhD, Centre for Hip Health and Mobility
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H10-00044
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Kliniske forsøg med Fracture - Boys
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-
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-
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-
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