Risk Taking and Fracture Study
An Investigation Into Risk Taking Behaviour, Bone Microstructure and Fracture Between the Sexes: What Underpins Fracture in Boys Compared to Girls During Growth?
1 other identifier
observational
319
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2010
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 11, 2013
CompletedFirst Posted
Study publicly available on registry
January 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedMay 23, 2017
May 1, 2017
5.3 years
January 11, 2013
May 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Characterization of factors that contribute to fractures in boys and girls
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 Outcomes (1)
Tracking of Risk Factors
4 years
Study Arms (4)
Fracture - Boys
Boys who have sustained a distal radius fracture
Fracture - Girls
Girls who have sustained a distal radius fracture
Non Fracture - Boys
Boys who have not sustained a distal radius fracture
Non Fracture - Girls
Girls who have not sustained a distal radius fracture
Interventions
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
Eligibility Criteria
Fracture patients will be recruited from the orthopaedic clinic at BC Children's Hospital. Non-fracture subjects will be recruited from the community
You may qualify if:
- 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
You may not qualify if:
- Fracture is a result of severe trauma
- Children with ontological medical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre for Hip Health and Mobility
Vancouver, British Columbia, V5Z 1M9, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather McKay, PhD
Centre for Hip Health and Mobility
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 11, 2013
First Posted
January 15, 2013
Study Start
June 1, 2010
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
May 23, 2017
Record last verified: 2017-05