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临床试验/NCT01192893
NCT01192893已完成不适用

Role of Oxytocin in Post-menopausal Osteoporosis: Evaluation on the Population of the OPUS Cohort

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
1
主要终点
oxytocin serum levels

研究概览

简要总结

Oxytocin is a neurohypophysial hormone involved in several central and peripheral functions including parturition, milk let-down reflex and social behaviour. In vitro and animals studies have shown growing evidence that oxytocin plays a role in bone remodeling and osteoporosis. The investigators have previously show in a small sample of post-menopausal women with severe osteoporosis (n=20) compare to healthy control (n=16) that oxytocin serum level is significantly decreased, independently of leptin and estradiol, that are known to modulate oxytocin secretion. Thus, oxytocin appears as a new interesting factor in the osteoporosis pathophysiology. The aim of the present study is to confirm the relationships between bone status, evaluated by bone mineral density and prevalent fragility fractures, body composition and oxytocin serum levels on a large population. The investigators will also determine if the relationship between bone mineral density and oxytocin is independent of estradiol and leptin in this population and evaluate the relationships between oxytocin serum level and co-morbidities such as cardiovascular diseases, depression and dementia. Theses analysis will be done on the serum already available of 1000 women of the international OPUS cohort. Bone mineral density, body composition analysis by Dual energy X-ray Absorptiometry (DXA), estradiol and clinical data are already available. The investigators will select women, aged from 55 to 79 y at the time of inclusion.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
55 Years 至 79 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • post-menopausal women,
  • able to undergo bone density,
  • without cognitive limitation,
  • Age at the time of inclusion: 55 -79y,
  • Written consent.

排除标准

  • Individuals were excluded because of inability to undergo bone densitometry or perform specified investigations or because of cognitive limitations

结局指标

主要结局

oxytocin serum levels

时间窗: at time = 0

oxytocin serum levels, measured by radio-immuno assay, at the spine and the hip in post-menopausal women

bone mineral density

时间窗: at time = 0

bone mineral density, measured by dual X ray absorptiometry at the spine and the hip in post-menopausal women

次要结局

  • Estradiol serum level(at time = 0)
  • leptin serum level(at time = 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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