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临床试验/NCT07412782
NCT07412782招募中不适用

Observational Study for the Assessment of Bone Mineral Density (BMD) Using REMS Technology

Meyer Children's Hospital IRCCS1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12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
招募中
发起方
入组人数
100
试验地点
1
主要终点
BMD values in primary osteoporosis

研究概览

简要总结

This study evaluates bone mineral density (BMD) in pediatric patients aged 5-18 years with conditions negatively affecting bone health, using REMS (Radiofrequency Echographic Multi Spectrometry), a non-invasive and radiation-free ultrasound technology. Bone health is crucial during childhood, when peak bone mass develops, and reduced BMD is associated with increased fracture risk. DXA is the current reference method but has limitations in children, including radiation exposure and growth-related measurement issues. REMS has been validated in adults and shows promise in pediatrics, despite the lack of reference values. The study is a single-center, national, non-profit interventional study lasting about 12 months. Participants will undergo REMS BMD measurement, clinical history collection, and assessment of anthropometric and pubertal parameters, with prior DXA data collected when available. The primary aim is to describe BMD values measured by REMS in pediatric osteoporosis, with secondary aims including subgroup analyses and comparison with DXA. A sample of 100 patients is planned. Statistical analyses will assess BMD distributions, correlations with clinical variables, and agreement between REMS and DXA using correlation coefficients and Bland-Altman analysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent from adult patients or parents/legal guardians
  • Age between 5 and 18 years
  • Both sexes and all ethnicities
  • Known condition negatively affecting bone health

排除标准

  • - Age below 5 years or over 18 years

研究组 & 干预措施

Diagnostic Test

Experimental

干预措施: REMS (Diagnostic Test)

结局指标

主要结局

BMD values in primary osteoporosis

时间窗: At the enrollement

Mean and median of Bone Mineral Density values obtained in the pediatric population affected by primary osteoporosis

次要结局

  • BMD values in pediatric patients with conditions negatively affecting bone health(At the enrollement)

研究者

发起方
Meyer Children's Hospital IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefano Stagi

MD

Meyer Children's Hospital IRCCS

研究点 (1)

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