Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device
brief summary
Osteoporosis is a widespread medical condition among older people. It causes the bones to weaken and become more likely to break. Osteoporosis and bone fracture risk are currently evaluated by looking at clinical risk factors and measuring bone mineral density (BMD). The lower the BMD is, the higher the risk of osteoporotic fractures in the future. However, most bone fractures occur in people who do not have very low BMD values. This means that osteoporosis and fracture risk are often not diagnosed. Many of these non-diagnosed patients would benefit from treatment to reduce the probability of bone fractures. An X-ray device called DXA is the main tool used to diagnose osteoporosis and fracture risk clinically. DXA measures two-dimensional BMD in the hip and spine. The POROUS ultrasound device measures various properties of the outer layer of the bone in the lower leg. It has several advantages over DXA: (1) its image resolution is higher and three-dimensional; (2) it can detect bone changes without radiation; (3) it can detect these bone changes early and how they change over time. For this clinical study, we will recruit men and women over 55 years old. Most will have clinical risk factors, such as background diseases, for developing osteoporosis. The study is anticipated to last 4 years. Our major research questions are: * Can the POROUS ultrasound device predict fracture risk? * How does its performance compare to DXA? * What is the safety of the new device? The participants will: * answer questions about their medical history. * be measured for height and weight, and take a physical test. * be examined for the presence of 'silent' fractures in the spine. * be examined at the beginning and end of the study with the two devices, DXA and POROUS. * be called by telephone every six months and asked if they suffer from new bone fractures, take any medication that might affect their bones, or if their health status has changed. The participants will be monitored for 3 years.
detailed description
Background and purpose:
Currently, osteoporosis and fracture risk are indirectly evaluated via the assessment of risk factors and bone mineral density (BMD) measurement. Although BMD is currently the most important indicator for osteoporosis-associated bone fractures, most of those fractures occur in persons who do not show pathologically reduced BMD value. Therefore, osteoporosis is one of the most frequently underdiagnosed common diseases. Established guidelines for the diagnosis of osteoporosis recommend the assessment of fracture risk factors and the T-Score, which is derived from the measurement of areal bone mineral density (aBMD) by means of DXA at major fracture sites, i.e., spine and proximal femur. DXA is regarded as the "gold standard" well-established methodology to determine aBMD for diagnostic purposes. Epidemiological data emphasize the urgency of developing diagnostic tools that can improve fracture risk prediction so that patients can be treated with the appropriate anti-osteoporotic therapies. Current guidelines for diagnosis and treatment lead to treatment gaps. It is estimated that at least 80% of males and 77% of females who would benefit from osteoporosis treatment are neither diagnosed nor treated in Germany.
Device description:
The POROUS R3C ultrasound device enables a non-invasive, non-ionizing quantitative detection of microstructural bone changes. As opposed to diagnosis based on a combination of clinical risk factors and a relative decrease of BMD, the novel device enables detecting pathological changes of bone microstructure at an earlier timepoint as well as monitoring such changes in a longitudinal manner. In the course of this clinical investigation, data will be collected to establish relevant ultrasound-based physical biomarkers for the prediction of fracture risk.
Study design:
This is a single-cohort, multicenter, prospective, age- and sex-stratified study in participants \> 55 years of age. In this study, Baseline data will be collected to establish a corrected standardized gradient of fracture risk using the POROUS R3C ultrasound device and test its performance in predicting fracture risk. Further, the performance of the POROUS R3C ultrasound device in the analysis of cortical bone properties and discrimination of prevalent fractures will be assessed. Participants will be enrolled into different groups based on their age (consisting of five-year bands), sex (males and females), and risk status for hip and vertebral fractures (i.e., high risk of ≥ 2-fold and low risk of \< 2-fold increased risk compared to the general population of the same age and sex).
official title
A Prospective, Single-cohort, Multicentre Clinical Investigation to Evaluate the Performance of POROUS R3C Ultrasound Device for Fracture Risk Prediction in Middle-aged and Elderly Men and Women