Risk Taking and Fracture Study

Fracture Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768598
• Other study ID #: H10-00044
• Status: Completed
• Phase: N/A
• First received: January 11, 2013
• Last updated: May 19, 2017
• Start date: June 2010
• Est. completion date: September 2015

Study information

• Verified date: May 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone

Intervention

Other:
• Fracture - Boys
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
• Fracture - Girls
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
• Non Fracture - Boys
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
• Non Fracture - Girls
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
Canada	Centre for Hip Health and Mobility	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of factors that contribute to fractures in boys and girls	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	Baseline (<3 months after injury)
Secondary	Tracking of Risk Factors	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