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
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.
• Female or male individuals aged 56 to and including 85 years.
• Written informed consent has been obtained.
⁃ Assessment of risk factors for hip and vertebral fractures:
⁃ To avoid over- and under-recruiting with regard to the required sample size of participants with ≥ 2-fold increased age-and sex-adjusted risk for hip and vertebral fractures and participants with \< 2-fold increased age- and sex-adjusted risk, clinical risk factors necessary for the calculation of the risk for hip and vertebral fractures (based on the risk calculation scheme outlined in the DVO osteoporosis guideline) are assessed at Screening.
⁃ Vertebral fractures:
• Vertebral fracture(s) during the last year
• Vertebral fracture(s) \> 12 months ago
• Number of vertebral fractures
• Maximal severity of vertebral fractures, according to Genant
⁃ Hip fractures and other fractures:
• Hip fracture during the last year
• Hip fracture \> 12 months ago
• Humerus fracture
• Pelvic fracture
• Wrist (radius distal) fracture
⁃ General risk factors:
• Mother or father with hip fracture, if the participant is under 75 years of age
• Significant alcohol consumption (50 g/day or more)
• Smoking (currently \> 10 cigarettes/day)
• Chronic-obstructive pulmonary disease (COPD)
• Body Mass Index (BMI) ≤ 20
⁃ Medication:
• Opioids
• Proton pump inhibitors \> 3 months
• Oral glucocorticoids \> 3 months (prednisone equivalent in mg/d)
⁃ Fall-associated risk factors/geriatrics:
• Number of falls within the last year
• Chronic hyponatremia
• Depression/antidepressants
• Anticonvulsants in epilepsy
• Immobility (being dependent on a walking aid)
• Alzheimer's disease/dementia
• Parkinson's disease
• Multiple sclerosis
• Stroke
• Time up and Go Test \> 12 seconds in participants ≥ 70 years of age
⁃ Endocrinology:
• Diabetes mellitus Type I
• Diabetes mellitus Type II (including time since onset)
• Primary hyperparathyroidism
• Thyroid-stimulating hormone (TSH) suppression (if yes, including TSH level)
⁃ Other diseases/medications:
• Chronic heart failure
• Monoclonal gammopathy of unclear significance (MGUS)
• Chronic kidney disease (CKD) stages 3a, 3b, 4
⁃ Rheumatology:
• Rheumatoid arthritis
• Axial spondyloarthritis