Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device

Prior treatment

• Previous medical procedures involving exposure to a cumulative dose of ionising radiation deemed by the Investigator to exceed usual limits within standard of care.
• Close affiliation with an investigational site, e.g. employed at investigational site, close relative of an investigator, dependent person (e.g. student of the investigational site).
  • Further, individuals who are being or have been treated within the indicated period prior to the beginning of the study with any of the following antiresorptive therapies are excluded from the clinical investigation:
• Hormone replacement therapy (HRT) including combination therapy or oestrogen alone in postmenopausal women within the last 6 months.
• Raloxifene within the last 6 months.
  • Individuals who are being or have ever been treated with any of the following anabolic therapies are excluded from the clinical investigation:

Other illness

• Presence of diseases that rule out valid measurements with the DXA and/or POROUS R3C devices (e.g., fractures or metal implants in the examined bones, paralysis of the lower extremities, severe bone abnormalities).

Other

• Inability to undergo the investigations required by the Clinical Investigation Plan (CIP) or cognitive limitations that preclude understanding of the Participant Information Sheet and the Informed Consent Document.
• Pregnancy and breastfeeding
• Enrolment in any other interventional clinical study (current or during the last three months)
• Individual is in custody by order of an authority or a court of law.
• Bisphosphonates (due to residual effects of bisphosphonates after discontinuation):
  • Intravenous (IV) zoledronate within the last 3 years.
  • Oral alendronate within the last year, if (continuous) treatment duration before was \> 1 year.
  • Oral risedronate within the last year, if (continuous) treatment duration before was \> 1 year.
  • Ibandronate (IV or oral) within the last year, if (continuous) treatment duration before was \> 1 year.
• Denosumab within the last 3 years
• Teriparatide
• Romosozumab
• Abaloparatide.

• 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