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Risk Taking and Fracture Study

2017年5月19日 更新者:Heather McKay、Canadian Institutes of Health Research (CIHR)

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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (实际的)

319

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • British Columbia
      • Vancouver、British Columbia、加拿大、V6H 3V4
        • British Columbia Children's Hospital
      • Vancouver、British Columbia、加拿大、V5Z 1M9
        • Centre for Hip Health and Mobility

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

8年 至 15年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Fracture patients will be recruited from the orthopaedic clinic at BC Children's Hospital.

Non-fracture subjects will be recruited from the community

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Fracture - Boys
Boys who have sustained a distal radius fracture
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
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
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
Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Characterization of factors that contribute to fractures in boys and girls
大体时间: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
Baseline (<3 months after injury)

次要结果测量

结果测量
措施说明
大体时间
Tracking of Risk Factors
大体时间: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.
4 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Heather McKay, PhD、Centre for Hip Health and Mobility

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2010年6月1日

初级完成 (实际的)

2015年9月1日

研究完成 (实际的)

2015年9月1日

研究注册日期

首次提交

2013年1月11日

首先提交符合 QC 标准的

2013年1月11日

首次发布 (估计)

2013年1月15日

研究记录更新

最后更新发布 (实际的)

2017年5月23日

上次提交的符合 QC 标准的更新

2017年5月19日

最后验证

2017年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • H10-00044

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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