Overview

This trial is active, not recruiting.

Condition fracture
Treatments fracture - boys, fracture - girls, non fracture - boys, non fracture - girls
Sponsor Canadian Institutes of Health Research (CIHR)
Start date January 2010
End date September 2016
Trial size 400 participants
Trial identifier NCT01768598, H10-00044

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Boys who have sustained a distal radius fracture
fracture - boys
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
Girls who have sustained a distal radius fracture
fracture - girls
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
Boys who have not sustained a distal radius fracture
non fracture - boys
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
Girls who have not sustained a distal radius fracture
non fracture - girls
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years

Primary Outcomes

Measure
Characterization of factors that contribute to fractures in boys and girls
time frame: Baseline (<3 months after injury)

Secondary Outcomes

Measure
Tracking of Risk Factors
time frame: 4 years

Eligibility Criteria

Male or female participants from 8 years up to 15 years old.

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

Additional Information

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?
Principal investigator Heather McKay, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by University of British Columbia.