Loss of bone health is a global health problem in aging populations. Every third women and every fifth men is at risk of osteoporosis. Osteoporosis results from misbalance of bone resorption and formation processes. These misbalances affect bone microstructure leading to increased pores and higher porosity and eventually to substantial loss of bone density. Thus, osteoporosis increases the risk of bone fractures, reduces mobility and life quality, and increases mortality.
The current standard of diagnostic, measuring bone mineral density (BMD) by dual-energy X-ray absorptiometry, has severe limitations. 60% of patients that already suffered an fragility fracture actually have a BMD-score above the osteoporotic theshold. It has been estimated that current diagnostic and treatment guidelines prevent at least 80% of individuals with increased fracture risk from receiving therapies to reduce the risk (1,2).
The cortical ultrasound backscatter (CortBS) analysis detects microstructural changes in cortical bone by means of a novel analysis of ultrasound backscatter spectra using conventional 3D ultrasound scanner technology. Potentially, the onset and progression of pathological changes can be detected long before the first osteoporotic fracture occurs and ideally when preventive action can still be taken. Also, changes in cortical bone structure in response to treatment can be monitored with higher sensitivity, higher specificity and earlier than with current methods. Thereby, the method and can potentially deliver feedback on therapeutic efficacy and adherence to treatment. In comparison with the current gold standard, BMD-DXA, the CortBS analysis is a radiation free method that might identify patients at risk despite of a normal BMD.
Co-Development with potential for licensing.
CortBS is adaptable to conventional 3D ultrasound systems that are widely distributed in the health sector. Data was captured using a conventional 3D ultrasound system. Validity of the data analysis has been shown on 20 human cadaver bones ex vivo.
Priority patent application filed in 2017.
The method has been presented in 2017 at the International Bone Densitometry workshop / European Symposium on Ultrasonic Characterization of Bone in Banz, Germany (http://www.ibdw-esucb-2017.de/), and at the International Ultrasonics Symposium in Washington DC, (http://ewh.ieee.org/conf/ius/2017/).
1) Kanis et al., 2014 The osteoporosis treatment gap. J Bone Miner Res., 29:1926-8.
2) Siris et al., 2004. Bone mineral density thresholds for pharmacological intervention to prevent fractures. Arch Intern Med. 164(10):1108-12
3) Global Data. Osteoporosis - Global Drug Forecast and Market Analysis to 2022. GDHC43PIDR / Published January 2013