A Bone Quality Diagnostic Instrument for the Improved Assessment of Fracture Risk

描述（由申请人提供）：骨质疏松症是影响美国超过4400万人的主要医学问题，其中相当多的人将经历低冲击性骨折。为了有效地评估这一人群的骨折风险，必须能够直接测量反映骨组织整体力学能力的患者骨质量参数。目前没有任何方法或仪器可以安全和实际地执行这项任务。BioDent参考点压痕仪已经成为实验室研究的主题超过六年，最近的研究支持其测量骨质疏松患者关键骨特性的能力。BioDent通过使用微压痕过程量化骨组织微骨折，微骨折和一般骨折发生率之间存在很强的相关性。该建议的中心假设是（HP 1）通过参考点压痕进行的微创微观水平原位骨质量测量是器官水平骨脆性的可靠指标;（HP 2）在胫骨处进行的参考点压痕测量显示出与同一供体内常见骨折部位相似的脆性趋势;（HP3）参考点压痕法能进一步判别骨脆性，其准确度和保真度均高于BMD。拟议的研究将使用BioDent参考点压痕系统、机械测试和DeXA严格测试这些假设，以证明微创压痕可以比DeXA更准确地预测骨脆性。 公共卫生相关性：美国有超过4400万骨质疏松症患者。目前，没有诊断方法可以预测在这些个体中观察到的大量低冲击骨折。拟定研究旨在开发一种可安全、直接测量骨材料抗断裂性的仪器。

DESCRIPTION (provided by applicant): Osteoporosis is a major medical problem affecting over 44 million individuals in the US, and a substantial number of those individuals will experience a low impact fracture. To effectively assess fracture risk in this population, one must be able to directly measure bone quality parameters in a patient that reflects the overall mechanical competence of the bone tissue. No current method or instrument can safely and practically perform that task. The BioDent Reference Point Indenter has been the subject of laboratory research for over six years, and recent studies support its ability to measure critical bone properties in osteoporotic individuals. BioDent quantifies bone tissue microfractures through the use of a microindentation process, and there is a strong relationship between microfracture and general fracture incidence. The central hypotheses of this proposal are (HP 1) minimally invasive micro-level in situ bone quality measurements via Reference Point Indentation are robust indicators of organ-level bone fragility; (HP 2) Reference Point Indentation measurements made at the tibiae exhibit similar trends of fragility as the common fracture sites within the same donor; and (HP 3) Reference Point Indentation measurements can further discriminate bone fragility with higher fidelity and accuracy than BMD. The proposed study will rigorously test these hypothesis using the BioDent Reference Point Indentation system, mechanical testing, and DeXA to demonstrate that minimally invasive indentations can predict bone fragility to a greater degree of accuracy than DeXA. PUBLIC HEALTH RELEVANCE: There are over 44 million osteoporosis patients in the US. Currently, no diagnostic method can predict the high number of low impact fractures observed among those individuals. The proposed study is directed to an instrument that safely and directly measures the resistance of bone material to fracture.