An Investigation of a New Pulse Echo Ultrasound Scanner, the Bindex®, for the Assessment of Osteoporosis in an English Population

Abstract

With its characteristic decrease in bone mass and deteriorated bone structure, osteoporosis increases fracture risk, resulting in a decreased quality of life, increased morbidity and mortality. To avoid fractures and minimise long-term health consequences, early diagnosis is key in terms of providing timely preventative healthcare treatments and interventions. Dual energy X-ray absorptiometry (DXA) remains the gold standard for assessing bone mineral density (BMD), but its limited accessibility and high cost restrict its use in many settings. Bindex®, a portable and radiation-free device using pulse-echo ultrasound, presents a promising alternative. Comparing its diagnostic performance to DXA may support its utility as a point-of-care tool for early osteoporosis detection and triage. This thesis assesses the diagnostic utility of the Bindex® scanner, as a convenient alternative to DXA. Participants aged 40 and above were recruited, based on diabetes status, fracture history, and general health. Bone health was assessed using the Bindex® and compared with DXA. Bindex® was used to calculate the Density Index (DI) at the tibia and radius, while DXA scans were performed at the lumbar spine, both femurs, right knee and right forearm. Statistical analysis included precision testing, correlation and agreement using Pearson’s correlation and Bland Altman plots, and diagnostic accuracy through ROC curve analysis. Linear regression was applied to assess age related changes, and participant acceptability of both scanning methods was also evaluated. The study demonstrated moderate to strong correlations between Bindex® DI measurements and DXA-derived BMD, particularly at the femoral neck. A key finding was that Bindex® showed good diagnostic performance in identifying individuals at risk of osteoporosis, with sensitivity improving to 100% when a population-specific DI threshold of 1.056 g/cm² was applied. Precision analysis confirmed acceptable inter- and intra-operator reliability. Age was found to have a significant but modest association with both DI and BMD values. Participant feedback indicated a high level of acceptability for Bindex® scanning, supporting its potential as a practical and accessible tool for osteoporosis screening, particularly in primary care settings.