Risk Taking and Fracture Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia ( Canadian Institutes of Health Research (CIHR) )
ClinicalTrials.gov Identifier:
NCT01768598
First received: January 11, 2013
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Fracture
Other: Fracture - Boys
Other: Fracture - Girls
Other: Non Fracture - Boys
Other: Non Fracture - Girls

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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?

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Characterization of factors that contribute to fractures in boys and girls [ Time Frame: Baseline (<3 months after injury) ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Tracking of Risk Factors [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 400
Study Start Date: January 2010
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fracture - Boys
Boys who have sustained a distal radius fracture
Other: Fracture - Boys
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
Other: Fracture - Girls
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
Other: Non Fracture - Boys
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
Other: Non Fracture - Girls
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years

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

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768598

Locations
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Centre for Hip Health and Mobility
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Heather McKay, PhD Centre for Hip Health and Mobility
  More Information

No publications provided

Responsible Party: University of British Columbia ( Canadian Institutes of Health Research (CIHR) )
ClinicalTrials.gov Identifier: NCT01768598     History of Changes
Other Study ID Numbers: H10-00044
Study First Received: January 11, 2013
Last Updated: June 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Wrist Fracture
Adolescents
Risk Taking Behaviour
Bone Microstructure

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014