Risk Taking and Fracture Study

NCT ID: NCT01768598

Last Updated: 2017-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

319 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fracture - Boys

Boys who have sustained a distal radius fracture

Fracture - Boys

Intervention Type OTHER

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

Fracture - Girls

Intervention Type OTHER

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

Non Fracture - Boys

Intervention Type OTHER

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

Non Fracture - Girls

Intervention Type OTHER

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

Interventions

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Fracture - Boys

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

Intervention Type OTHER

Fracture - Girls

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

Intervention Type OTHER

Non Fracture - Boys

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

Intervention Type OTHER

Non Fracture - Girls

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role lead

Responsible Party

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Heather McKay

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heather McKay, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Hip Health and Mobility

Locations

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Centre for Hip Health and Mobility

Vancouver, British Columbia, Canada

Site Status

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H10-00044

Identifier Type: -

Identifier Source: org_study_id

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