Risk Taking and Fracture Study

May 19, 2017 updated by: Heather McKay, Canadian Institutes of Health Research (CIHR)

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

319

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • British Columbia Children's Hospital
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Centre for Hip Health and Mobility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of factors that contribute to fractures in boys and girls
Time Frame: Baseline (<3 months after injury)

The factors include:

  1. Risk taking behaviour - protection motivation variables, anticipated regret and excitement and impulsivity dispositions
  2. Body composition - total body mass, fat mass, lean mass
  3. Bone microstructure - cortical and trabecular bone outcomes
  4. Dietary intake - calcium
  5. Physical activity
Baseline (<3 months after injury)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Heather McKay, PhD, Centre for Hip Health and Mobility

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2010

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 11, 2013

First Submitted That Met QC Criteria

January 11, 2013

First Posted (Estimate)

January 15, 2013

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 19, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H10-00044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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