Observational Study for the Assessment of Bone Mineral Density (BMD) Using REMS Technology
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
- 否
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
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
Stefano Stagi
MD
Meyer Children's Hospital IRCCS
