FractureNCT01768598
Risk Taking and Fracture Study
An observational study of Fracture, run by Canadian Institutes of Health Research (CIHR) at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Fracture
- What is being tested?
- Fracture - Boys, Fracture - Girls and Non Fracture - Boys
- How many people
- 319 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2010to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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
Who cannot join
- Fracture is a result of severe trauma
- Children with ontological medical conditions
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Centre for Hip Health and Mobility
Vancouver, British Columbia, V5Z 1M9
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
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?
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.
Read the 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.
- Conditions
- Fracture
- Being tested
- Fracture - Boys, Fracture - Girls, Non Fracture - Boys, Non Fracture - Girls
- Keywords
- Wrist Fracture, Adolescents, Risk Taking Behaviour, Bone Microstructure
- Medical subject headings
- Fractures, Bone, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fracture - BoysOther
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
Fracture - GirlsOther
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
Non Fracture - BoysOther
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
Non Fracture - GirlsOther
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
| Study group | Role | What they receive |
|---|---|---|
| Fracture - Boys | Boys who have sustained a distal radius fracture Receives: Other: Fracture - Boys | |
| Fracture - Girls | Girls who have sustained a distal radius fracture Receives: Other: Fracture - Girls | |
| Non Fracture - Boys | Boys who have not sustained a distal radius fracture Receives: Other: Non Fracture - Boys | |
| Non Fracture - Girls | Girls who have not sustained a distal radius fracture Receives: Other: Non Fracture - Girls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (<3 months after injury)
Secondary outcomes (1)
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startJun 2010
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Institutes of Health Research (CIHR)
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Heather McKay, University of British Columbia
- Investigators
- Heather McKay, PhD, Principal investigator, Centre for Hip Health and Mobility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768598
- Sponsor's protocol ID
- H10-00044
- Status last verified
- May 2017
- First submitted
- 11 Jan 2013
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT01768598
- Acronym / sponsor ID
- H10-00044
- Conditions
- Fracture
- Keywords
- Wrist Fracture, Adolescents, Risk Taking Behaviour, Bone Microstructure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Canadian Institutes of Health Research (CIHR)Other government
- Study start
- Jun 2010 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fracture - Boys | – | Other: Fracture - BoysBoys who have sustained a distal radius fracture |
| Fracture - Girls | – | Other: Fracture - GirlsGirls who have sustained a distal radius fracture |
| Non Fracture - Boys | – | Other: Non Fracture - BoysBoys who have not sustained a distal radius fracture |
| Non Fracture - Girls | – | Other: Non Fracture - GirlsGirls who have not sustained a distal radius fracture |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Fracture is a result of severe trauma
- Children with ontological medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fracture - BoysAnnual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years | Other | Fracture - Boys |
| Fracture - GirlsAnnual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years | Other | Fracture - Girls |
| Non Fracture - BoysAnnual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years | Other | Non Fracture - Boys |
| Non Fracture - GirlsAnnual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years | Other | Non Fracture - Girls |
Primary outcome
Characterization of factors that contribute to fractures in boys and girls
Time frame: Baseline (<3 months after injury)
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
1 secondary outcome
Tracking of Risk Factors
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather McKay, PhD principal investigator
Centre for Hip Health and Mobility
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture, run by Canadian Institutes of Health Research (CIHR) at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of factors that contribute to fractures in boys and girls (time frame: Baseline (<3 months after injury)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.