Clinical trial NCT01768598: Risk Taking and Fracture Study
Official title: An Investigation Into Risk Taking Behaviour, Bone Microstructure and Fracture Between the Sexes: What Underpins Fracture in Boys Compared to Girls During Growth?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fracture
Keywords: Wrist Fracture
Adolescents
Risk Taking Behaviour
Bone Microstructure
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 319
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fracture patients will be recruited from the orthopaedic clinic at BC Children's Hospital.

Non-fracture subjects will be recruited from the community

Brief summary: 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.

Detailed description: The investigators aim to better characterize factors that contribute to fracture in boys and girls and to assess whether such factors track across a four year period. The innovation is to use novel methods and an integrated approach, to measure the influence of risk-taking behaviour, body composition, bone microstructure, motor proficiency, diet and physical activity in one model across growth. This will provide a more comprehensive picture of the key multi-factorial predictors of fracture within- and between-sexes. This essential information will provide the basis for change in public health policy, clinical practice, community programs, and targeted interventions.

Eligibility criteria: 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

Primary outcomes:
measure: Characterization of factors that contribute to fractures in boys and girls
timeFrame: Baseline (<3 months after injury)
Secondary outcomes:
measure: Tracking of Risk Factors
timeFrame: 4 years
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Centre for Hip Health and Mobility
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
Study officials:
affiliation: Centre for Hip Health and Mobility
name: Heather McKay, PhD
role: PRINCIPAL_INVESTIGATOR
References: