A New Device to measure Whole and Tissue Level Bone Strength.

一种测量整体和组织水平骨强度的新设备。

• 批准号: 10613794
• 负责人: Peter Burks
• 金额: $ 29.96万
• 依托单位: ACTIVE LIFE SCIENTIFIC, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-01-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10613794
• 关键词: Acquired Immunodeficiency Syndrome; Address; Administrative Supplement; Affect; Age; American; Area; Award; Bone Density; Bone Diseases; Bone Tissue; Cadaver; Clinic; Clinical; Clinical Research; Devices; Diagnosis; Diagnostic; Disabled Persons; Disease; Documentation; Dual-Energy X-Ray Absorptiometry; Economic Burden; Europe; Exhibits; Fracture; Future; Glues; Gold; HIV; HIV Seropositivity; Health Care Costs; Hip Fractures; Human; Impairment; Individual; Investments; Laboratory Research; Length; Life Style; Measurement; Measures; Mechanics; Medical Device; Methodology; Methods; Microscopic; Minerals; Monitor; Morbidity - disease rate; Neck; Osteoporosis; Palpation; Parents; Patients; Persons; Phase; Physicians; Population; Postmenopause; Privatization; Process; Radiation; Radiation exposure; Research; Resolution; Risk; Sampling; Site; Small Business Innovation Research Grant; Tactile; Techniques; Testing; Tissues; Touch sensation; Translating; United States Food and Drug Administration; United States National Institutes of Health; Walking; Woman; Wrist; aging population; base; bone; bone fragility; bone health; bone mass; bone quality; bone strength; clinical examination; clinically relevant; co-infection; comorbidity; design; experience; fracture risk; fragility fracture; high risk; improved; indexing; men; new technology; normal aging; novel strategies; phase 2 study; research and development; research clinical testing; resilience; response; sensor; skeletal; spine bone structure; tibia

Project Summary/Abstract Most patients who fracture have non-osteoporotic bone mineral density. Often, the result of a fracture is devastating and results in substantial morbidity and health care costs. One cause of fragility in these patients is poor bone quality that subsequently contributes to higher risk for fracture. Yet few techniques are available to accurately assess bone quality in the clinic. Dual energy x-ray absorptiometry (DXA) is the most used clinical surrogate for fracture risk, but DXA does not account for bone quality and thus overestimates bone health. OsteoProbe® enables the measurement of bone quality in human patients and has been FDA cleared. The OsteoProbe® quantifies bone material quality as a measure termed bone material strength index (BMSi) at the tibia through a rapid microindentation process. A significant and highly predictive relationship has been demonstrated between tibial BMSi and fracture occurrence at multiple skeletal sites. BMSi has also been shown to be strongly predictive of bone strength at the femoral neck. The ongoing SBIR Phase II study is investigating the relationship between OsteoProbe measurements at the tibia and bone strength at these clinically relevant skeletal sites on post-menopausal cadavers. We hypothesize that OsteoProbe® measurements will also prove valuable for HIV patients who are at higher risk of fracture but do not have low BMD. The proposal aims to: (1) Contrast DEXA and BMSi as predictors of true bone strength between HIV+ and HIV- populations across multiple skeletal sites, and (2) Determine the microstructural and tissue-level changes in HIV bone that is detectable by the OsteoProbe, compared with those of the normal aging population. We hypothesize that HIV+ bones will exhibit impairments at lower length scales that differentially affects BMSi than non-HIV bones.

项目概要/摘要 大多数骨折患者具有非骨质疏松性骨密度。通常，一个结果 骨折是毁灭性的，会导致大量的发病率和医疗费用。原因之一是 这些患者的脆弱性是骨质质量差，从而导致更高的风险 断裂。然而，很少有技术可以在临床上准确评估骨质量。双重的 能量 X 射线吸收测定法 (DXA) 是临床上最常用的骨折风险替代方法，但 DXA 没有考虑骨骼质量，因此高估了骨骼健康。 OsteoProbe® 能够 用于测量人类患者的骨质量，并已获得 FDA 批准。 OsteoProbe® 将骨材料质量量化为骨材料强度指数 (BMSi) 的衡量标准 通过快速微压痕过程对胫骨进行切割。显着且高度预测的关系 胫骨 BMSi 与多个骨骼部位骨折发生之间的关系已得到证实。骨髓硅 还被证明可以强烈预测股骨颈的骨强度。正在进行的 SBIR II 期研究正在调查 OsteoProbe 测量值之间的关系 绝经后尸体上这些临床相关骨骼部位的胫骨和骨强度。 我们假设 OsteoProbe® 测量对于以下 HIV 患者也很有价值： 骨折风险较高，但骨密度不低。该提案的目的是：（1）对比DEXA 和 BMSi 作为多个 HIV+ 和 HIV- 人群之间真实骨强度的预测因子 骨骼部位，以及 (2) 确定 HIV 骨骼的微观结构和组织水平变化，即 与正常老龄化人群相比，可通过 OsteoProbe 检测到。我们 假设 HIV+ 骨骼会在较低长度尺度上表现出损伤，这些损伤与 与非 HIV 骨骼相比，对 BMSi 的影响更大。