Evaluation of Bone Architecture and Bone Strength in Adults With Hypophosphatasia (HPP)
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Differences in Bone Mineral Strength Index (BMSi) between the two groups, assessed by microindentation (OsteoProbe®).
研究概览
简要总结
The study aims to evaluate the bone architecture and bone strength in adults with Hypophosphatasia (HPP).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Differences in Bone Mineral Strength Index (BMSi) between the two groups, assessed by microindentation (OsteoProbe®).
时间窗: 1. October 2019 - 31.July 2020
Differences in BMSi between the HPP- and Control-Group will be evaluated by microindentation (OsteoProbe®). Microindentation is a technology directly measuring bone strength by a minimal invasive technique. By applying a standardized pressure with a probe, which at the same time measures the indentation depth in the tibia bone, a measure of bone strength is obtained and calculated as Bone Mineral Strength Index (BMSi) \[1\].
次要结局
- Evaluation of differences in bone microarchitecture between the HPP- and Control-Group by high resolution peripheral quantitative computed tomography (HRpQCT).(1. October 2019 - 31.July 2020)
- Evaluation of differences in bone homeostasis between the two groups by biochemical analysis of different bone markers (P1NP, CTx, BALP, Trab-5, Sclerostin, Osteocalcin and FGF23)(1. October 2019 - 31.July 2020)
- Correlation between BMSi and fracture prevalence in the HPP-Group and the Control-Group.(1. October 2019 - 31.July 2020)
研究者
Nicola Hepp
Principal Investigator, MD
Hvidovre University Hospital