Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device
- Conditions
- OsteopeniaHealthyOsteoporosis
- Registration Number
- NCT06567054
- Lead Sponsor
- POROUS GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 1600
Inclusion Criteria:<br><br> - Female or male individuals aged 56 to and including 85 years.<br><br> - Written informed consent has been obtained.<br><br>Assessment of risk factors for hip and vertebral fractures:<br><br>To avoid over- and under-recruiting with regard to the required sample size of<br>participants with = 2-fold increased age-and sex-adjusted risk for hip and vertebral<br>fractures and participants with < 2-fold increased age- and sex-adjusted risk, clinical<br>risk factors necessary for the calculation of the risk for hip and vertebral fractures<br>(based on the risk calculation scheme outlined in the DVO osteoporosis guideline) are<br>assessed at Screening.<br><br>Vertebral fractures:<br><br> - Vertebral fracture(s) during the last year<br><br> - Vertebral fracture(s) > 12 months ago<br><br> - Number of vertebral fractures<br><br> - Maximal severity of vertebral fractures, according to Genant<br><br>Hip fractures and other fractures:<br><br> - Hip fracture during the last year<br><br> - Hip fracture > 12 months ago<br><br> - Humerus fracture<br><br> - Pelvic fracture<br><br> - Wrist (radius distal) fracture<br><br>General risk factors:<br><br> - Mother or father with hip fracture, if the participant is under 75 years of age<br><br> - Significant alcohol consumption (50 g/day or more)<br><br> - Smoking (currently > 10 cigarettes/day)<br><br> - Chronic-obstructive pulmonary disease (COPD)<br><br> - Body Mass Index (BMI) = 20<br><br>Medication:<br><br> - Opioids<br><br> - Proton pump inhibitors > 3 months<br><br> - Oral glucocorticoids > 3 months (prednisone equivalent in mg/d)<br><br>Fall-associated risk factors/geriatrics:<br><br> - Number of falls within the last year<br><br> - Chronic hyponatremia<br><br> - Depression/antidepressants<br><br> - Anticonvulsants in epilepsy<br><br> - Immobility (being dependent on a walking aid)<br><br> - Alzheimer's disease/dementia<br><br> - Parkinson's disease<br><br> - Multiple sclerosis<br><br> - Stroke<br><br> - Time up and Go Test > 12 seconds in participants = 70 years of age<br><br>Endocrinology:<br><br> - Diabetes mellitus Type I<br><br> - Diabetes mellitus Type II (including time since onset)<br><br> - Primary hyperparathyroidism<br><br> - Thyroid-stimulating hormone (TSH) suppression (if yes, including TSH level)<br><br>Other diseases/medications:<br><br> - Chronic heart failure<br><br> - Monoclonal gammopathy of unclear significance (MGUS)<br><br> - Chronic kidney disease (CKD) stages 3a, 3b, 4<br><br>Rheumatology:<br><br> - Rheumatoid arthritis<br><br> - Axial spondyloarthritis<br><br>Exclusion Criteria:<br><br> - Presence of diseases that rule out valid measurements with the DXA and/or POROUS R3C<br> devices (e.g., fractures or metal implants in the examined bones, paralysis of the<br> lower extremities, severe bone abnormalities).<br><br> - Inability to undergo the investigations required by the Clinical Investigation Plan<br> (CIP) or cognitive limitations that preclude understanding of the Participant<br> Information Sheet and the Informed Consent Document.<br><br> - Previous medical procedures involving exposure to a cumulative dose of ionising<br> radiation deemed by the Investigator to exceed usual limits within standard of care.<br><br> - Pregnancy and breastfeeding<br><br> - Enrolment in any other interventional clinical study (current or during the last<br> three months)<br><br> - Individual is in custody by order of an authority or a court of law.<br><br> - Close affiliation with an investigational site, e.g. employed at investigational<br> site, close relative of an investigator, dependent person (e.g. student of the<br> investigational site).<br><br>Further, individuals who are being or have been treated within the indicated period prior<br>to the beginning of the study with any of the following antiresorptive therapies are<br>excluded from the clinical investigation:<br><br> - Bisphosphonates (due to residual effects of bisphosphonates after discontinuation):<br><br> - Intravenous (IV) zoledronate within the last 3 years.<br><br> - Oral alendronate within the last year, if (continuous) treatment duration<br> before was > 1 year.<br><br> - Oral risedronate within the last year, if (continuous) treatment duration<br> before was > 1 year.<br><br> - Ibandronate (IV or oral) within the last year, if (continuous) treatment<br> duration before was > 1 year.<br><br> - Denosumab within the last 3 years<br><br> - Hormone replacement therapy (HRT) including combination therapy or oestrogen alone<br> in postmenopausal women within the last 6 months.<br><br> - Raloxifene within the last 6 months.<br><br>Individuals who are being or have ever been treated with any of the following anabolic<br>therapies are excluded from the clinical investigation:<br><br> - Teriparatide<br><br> - Romosozumab<br><br> - Abaloparatide.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Endpoint, Part 1 - POROUS-Score based on prevalent fractures;Clinical Endpoint, Part 2 - POROUS-Score based on incident fractures
- Secondary Outcome Measures
Name Time Method Safety Endpoint;Performance Endpoint, Part 1 - DXA T-score;Performance Endpoint, Part 1 - discriminative performance based on prevalent fractures;Performance Endpoint, Part 2 - DXA T-score;Performance Endpoint, Part 2 - predictive performance based on incident fractures