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临床试验/NCT01258036
NCT01258036已完成不适用

Rôle de la Microarchitecture Osseuse Dans le déterminisme héréditaire de la fragilité Osseuse

Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 1,040 人开始时间: 2010年5月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,040
试验地点
1
主要终点
Role of bone microarchitecture in the hereditary determinism of bone fragility

研究概览

简要总结

The aim of this study is to analyze the hereditary determinism of bone microarchitecture measured at the distal radius and distal tibia from a case control-study of mother-daughter pairs.

详细描述

Many factors influence the risk of osteoporosis but one of the most important is a positive family history, emphasizing the importance of genetics in the pathogenesis of osteoporosis. Till now, most genetic studies in osteoporosis have focused on the phenotype of BMD. However, areal BMD (bone quantity per unit bone area measured) does not provide information regarding bone distribution (between cortical and cancellous compartments) or bone microarchitecture (trabecular number, thickness, spacing and distribution) and cortical (thickness, porosity). We are planning to analyze the hereditary determinism of bone microarchitecture assessed non invasively with HR pQCT at the distal radius and the distal tibia in a case-control study with fractured and not fractured mothers and their daughters. Additionally, the role of the bone turnover, hormones involved in regulating bone metabolism , bone geometry measured at the proximal femur and bone strength estimated by finite element analysis (μFE)in the hereditary determinism of bone fragility will be analyzed.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Case mothers: postmenopausal women who have at least one bone fragility fracture confirmed by radiological examination or by a surgical report. Fragility fracture is a fracture that occurs as a result of a fall from standing height or less. Fractures of the skull, fingers and toes will be excluded.
  • Control mothers: menopausal women not having suffered from bone fragility fracture.
  • Daughters: Women aged 20 and older (postmenopausal or not), biological daughters of participating mothers. Several daughters from the same mother may be included.
  • Mothers and some daughters are recruited from the OFELY (Os des FEmmes de LYon) cohort or the FMC (Filière MédicoChirurgicale).

排除标准

  • Adoptive daughters
  • Nonmenopausal mothers

研究组 & 干预措施

Fractured Mothers

Fractured Mothers and their daughters

干预措施: HRpQCT (Radiation)

Fractured Mothers

Fractured Mothers and their daughters

干预措施: Sampling (Biological)

Fractured Mothers

Fractured Mothers and their daughters

干预措施: Bone absorptiometry (Radiation)

Non fractured mothers

Mothers non fractured and their daughters

干预措施: HRpQCT (Radiation)

Non fractured mothers

Mothers non fractured and their daughters

干预措施: Sampling (Biological)

Non fractured mothers

Mothers non fractured and their daughters

干预措施: Bone absorptiometry (Radiation)

结局指标

主要结局

Role of bone microarchitecture in the hereditary determinism of bone fragility

时间窗: 18 months

Comparison of bone microarchitecture parameters from high resolution peripheral quantitative computer tomography (HRpQCT)between daughters according to the fracture status of their mother.

次要结局

  • Role of Bone mineral density in the hereditary determinism of bone fragility(18 months)
  • Role of bone turnover and hormones in the hereditary determinism of bone fragility(24 months)

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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