Prof. Kay Raum, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health; Dr Juan Du, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health; Gianluca Iori, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health
Osteoporosis is one of the most important global health problems of aging populations, which increases the risk of bone fractures, reduces mobility and quality of life, and increases mortality (1). The annual economic burden of incident and prior fragility fractures was estimated at € 37 billion and the costs are expected to increase by 25% in 2025 (2). In 2012, 169 Mio people in the eight major markets (USA, DE, FR, GB, IT, SP, JP, CN) were estimated to suffer from osteoporosis (3). The current standard diagnostic parameter is bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA). 458 Mio people were estimated to have osteopenia, i.e., a reduced bone mineral density above the osteoporotic threshold. However, approximately 40 % of all fragility fractures in females occur in women with osteopenia. Undiagnosed and untreated people with osteopenia, but increased fracture risk is a major global challenge. Current diagnostic and treatment guidelines prevent at least 80% of these individuals from receiving therapies to reduce the risk of future fractures.
Osteoporosis results from misbalance of bone resorption and formation processes. These misbalances affect the microstructure of the cortical bone leading to increased pores and higher porosity and eventually to substantial loss of bone density. The cortical ultrasound backscatter (CortBS) analysis detects these microstructural changes 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 and specificity. Thereby, the method can potentially deliver rapid 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. CortBS is adaptable to conventional 3D ultrasound systems that are widely distributed in the health sector.
Co-Development with potential for licensing.
Data was captured using a conventional 3D ultrasound system. Validity of the CortBS data analysis has been shown on 20 human cadaver bones ex vivo.
Priority 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.
2) Siris et al., 2004. Bone mineral density thresholds for pharmacological intervention to prevent fractures. Arch Intern Med.
3) Global Data. Osteoporosis - Global Drug Forecast and Market Analysis to 2022. GDHC43PIDR / Published January 2013
Distribution of fracture rate (gray) and absolute number (black) of fractures in women with respect to BMD expressed as T-score values (from NORA study (2)). The red box (38.9%) represents the female patient group in the focus of the CortBS method, which are – according to current guidelines – not receiving treatment, unless they have sustained a vertebral fragility fracture or other clinical risk factors.