Risk Taking and Fracture Study

Sponsor
Canadian Institutes of Health Research (CIHR) (Other)
Overall Status
Completed
CT.gov ID
NCT01768598
Collaborator
(none)
319
2
63
159.5
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fracture - Boys
  • Other: Fracture - Girls
  • Other: Non Fracture - Boys
  • Other: Non Fracture - Girls

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 Design

Study Type:
Observational
Actual Enrollment :
319 participants
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?
Actual Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

  1. Tracking of Risk Factors [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Centre for Hip Health and Mobility Vancouver British Columbia Canada V5Z 1M9
2 British Columbia Children's Hospital Vancouver British Columbia Canada V6H 3V4

Sponsors and Collaborators

  • Canadian Institutes of Health Research (CIHR)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heather McKay, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier:
NCT01768598
Other Study ID Numbers:
  • H10-00044
First Posted:
Jan 15, 2013
Last Update Posted:
May 23, 2017
Last Verified:
May 1, 2017
Keywords provided by Heather McKay, Principal Investigator, University of British Columbia
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 23, 2017