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Completed

NCT Number: NCT01768598

Risk Taking and Fracture Study

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.

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Key information

Conditions

Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

British Columbia Children's Hospital, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fracture - Boys

Other

Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years

Fracture - Girls

Other

Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years

Non Fracture - Boys

Other

Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years

Non Fracture - Girls

Other

Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years

Primary outcomes

  1. Characterization of factors that contribute to fractures in boys and girls

    Time frame: Baseline (<3 months after injury)

    The factors include:

    • Risk taking behaviour - protection motivation variables, anticipated regret and excitement and impulsivity dispositions
    • Body composition - total body mass, fat mass, lean mass
    • Bone microstructure - cortical and trabecular bone outcomes
    • Dietary intake - calcium
    • Physical activity

Secondary outcomes

  1. Tracking of Risk Factors

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Other Gov

Registry information

Official study title

An Investigation Into Risk Taking Behaviour, Bone Microstructure and Fracture Between the Sexes: What Underpins Fracture in Boys Compared to Girls During Growth?

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jan 15, 2013
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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