Dick Andrew, Stoeckel Max, Ruzzenne Massimo, von Sadovszky Tony, Simon Janet E, Clark Leatha A, Warden Stuart J, Manini Todd M, Lyssikatos Charalampos, Hart Tiffani, Clark Brian C
OsteoDx Inc., Athens, OH 45701, United States.
Department of Mechanical Engineering, University of Colorado, Boulder, CO 80309, United States.
JBMR Plus. 2025 Jul 9;9(9):ziaf116. doi: 10.1093/jbmrpl/ziaf116. eCollection 2025 Sep.
Current methods of diagnosing osteoporosis, such as DXA, have limitations in predicting fracture risk. Cortical bone mechanics technology (CBMT) offers a novel approach by using a three-point bend test with multifrequency vibration analysis to directly measure ulnar bending stiffness and calculate flexural rigidity, a mechanical property highly predictive of whole-bone strength under bending conditions. Cortical bone mechanics technology targets the diaphyseal ulna, a site composed primarily of cortical bone, enhancing its specificity for cortical bone quality. In this study of 388 postmenopausal women, we developed and validated a 20-point signal quality indicator (SQI) scoring system to quantify CBMT signal quality and evaluated its relationship to biometric characteristics. The SQI was developed through expert assessment of representative frequency response function (vibration data) trials and refined over 17 iterations. The final system achieved excellent classification performance (AUC = 0.974; sensitivity, specificity, and accuracy all >97%). A total of 22 740 trials were collected across 758 total arm tests, sampling 10 ulnar sites per arm under three vibration amplitudes. Two expert analysts evaluated signal features associated with high signal quality. The resulting SQI is fully automated and provides real-time feedback. All correlations between SQI scores and biometric attributes were weak or very weak (|ρ| < 0.30). The correlations with body weight (ρ = -0.11), BMI (ρ = -0.12), ulnar BMD (ρ = -0.17), CBMT-derived flexural rigidity (ρ = -0.28), and grip strength (ρ = 0.17) were statistically significant ( < .05) but remained small in magnitude. SQI scores were modestly lower in individuals with higher BMI or flexural rigidity (~2 to 3 points), but values remained in the acceptable-to-good range. This study introduces a robust, automated CBMT signal quality metric and demonstrates that its performance remains stable across a broad range of biometric profiles, supporting its application in both clinical and research settings.
当前诊断骨质疏松症的方法,如双能X线吸收法(DXA),在预测骨折风险方面存在局限性。皮质骨力学技术(CBMT)提供了一种新方法,通过三点弯曲试验结合多频振动分析来直接测量尺骨弯曲刚度并计算抗弯刚度,这是一种在弯曲条件下对全骨强度具有高度预测性的力学性能。皮质骨力学技术针对主要由皮质骨组成的尺骨干,提高了其对皮质骨质量的特异性。在这项针对388名绝经后女性的研究中,我们开发并验证了一种20分的信号质量指标(SQI)评分系统,以量化CBMT信号质量,并评估其与生物特征的关系。SQI是通过对代表性频率响应函数(振动数据)试验的专家评估而开发的,并经过17次迭代进行完善。最终系统实现了出色的分类性能(曲线下面积[AUC]=0.974;灵敏度、特异性和准确性均>97%)。在总共758次全臂测试中收集了22740次试验,在三种振动幅度下,每只手臂对10个尺骨部位进行采样。两名专家分析人员评估了与高信号质量相关的信号特征。所得的SQI是完全自动化的,并提供实时反馈。SQI评分与生物特征属性之间的所有相关性均较弱或非常弱(|ρ|<0.30)。与体重(ρ=-0.11)、体重指数(BMI)(ρ=-0.12)、尺骨骨密度(ρ=-0.17)、CBMT得出的抗弯刚度(ρ=-0.28)和握力(ρ=0.17)的相关性具有统计学意义(P<0.05),但幅度仍然较小。BMI较高或抗弯刚度较高的个体的SQI评分略低(约2至3分),但值仍处于可接受至良好范围内。本研究引入了一种强大的、自动化的CBMT信号质量指标,并证明其性能在广泛的生物特征范围内保持稳定,支持其在临床和研究环境中的应用。