- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01768598
Risk Taking and Fracture Study
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.
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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British Columbia
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Vancouver, British Columbia, 캐나다, V6H 3V4
- British Columbia Children's Hospital
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Vancouver, British Columbia, 캐나다, V5Z 1M9
- Centre for Hip Health and Mobility
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Fracture patients will be recruited from the orthopaedic clinic at BC Children's Hospital.
Non-fracture subjects will be recruited from the community
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Fracture - Boys
Boys who have sustained a distal radius fracture
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Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
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Fracture - Girls
Girls who have sustained a distal radius fracture
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Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
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Non Fracture - Boys
Boys who have not sustained a distal radius fracture
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Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
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Non Fracture - Girls
Girls who have not sustained a distal radius fracture
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Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Characterization of factors that contribute to fractures in boys and girls
기간: Baseline (<3 months after injury)
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The factors include:
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Baseline (<3 months after injury)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Tracking of Risk Factors
기간: 4 years
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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.
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4 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Heather McKay, PhD, Centre for Hip Health and Mobility
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- H10-00044
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Fracture - Boys에 대한 임상 시험
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The Miriam HospitalHassenfeld Child Health Innovation Institute완전한