- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
British Columbia
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Vancouver, British Columbia, Kanada, V6H 3V4
- British Columbia Children's Hospital
-
Vancouver, British Columbia, Kanada, V5Z 1M9
- Centre for Hip Health and Mobility
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Fracture patients will be recruited from the orthopaedic clinic at BC Children's Hospital.
Non-fracture subjects will be recruited from the community
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Characterization of factors that contribute to fractures in boys and girls
Tidsram: Baseline (<3 months after injury)
|
The factors include:
|
Baseline (<3 months after injury)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Tracking of Risk Factors
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Heather McKay, PhD, Centre for Hip Health and Mobility
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H10-00044
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