Predicting bone fracture risk using a new ultrasound device
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
This study is testing a new ultrasound device to see if it can better predict the risk of bone fractures in people with healthy bones, osteopenia, or osteoporosis compared to traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1600 (estimated) |
| Ages | 56 Years to 85 Years |
| Sex | All |
| Sponsor | POROUS GmbH Industry-sponsored |
| Drugs / interventions | Denosumab, Romosozumab, radiation, prednisone |
| Locations | 6 sites (Vienna and 5 other locations) |
| Trial ID | NCT06567054 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the effectiveness of the POROUS ultrasound device in predicting the risk of bone fractures in individuals with healthy bones, osteopenia, or osteoporosis. Unlike traditional methods that rely on bone mineral density (BMD) measurements, this device offers a non-invasive and three-dimensional assessment of bone microstructure. Participants will undergo measurements with the POROUS device alongside standard DXA assessments to compare results and improve fracture risk prediction. The goal is to identify individuals who may benefit from osteoporosis treatment but are currently undiagnosed.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 56 to 85 years, both male and female, who may have osteopenia or osteoporosis.
Not a fit: Patients who are younger than 56 years or do not have any risk factors for osteoporosis or fractures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate identification of patients at risk for bone fractures, allowing for timely intervention and treatment.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for fracture risk assessment, but the specific use of the POROUS ultrasound device represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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). * 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. * Previous medical procedures involving exposure to a cumulative dose of ionising radiation deemed by the Investigator to exceed usual limits within standard of care. * 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. * 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: * 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 * 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: * Teriparatide * Romosozumab * Abaloparatide.
Where this trial is running
Vienna and 5 other locations
- Division for Endocrinology and Metabolism, Department of Medicine 3, Medical University Vienna — Vienna, Austria (Recruiting)
- Department of Rheumatology, Charité Universitätsmedizin Berlin, Charite Campus Mitte — Berlin, State of Berlin, Germany (Recruiting)
- Centre of Muscle and Bone Research (ZMK), Charité Universitätsmedizin Berlin, Campus Benjamin Franklin — Berlin, State of Berlin, Germany (Recruiting)
- Department for Orthopedy, Trauma and Reconstructive Surgery, Section of Geriatric Traumatology, University Hospital Halle (Saale) — Halle, Germany (Recruiting)
- Department of Endocrinology, Reproductive Medicine and Osteology Clinic for Gynecology and Obstetrics, University Hospital of Giessen and Marburg — Marburg, Germany (Recruiting)
- VieCuri Medisch Centrum, Department of Internal Medicine, Venlo — Venlo, Netherlands (Recruiting)
Study contacts
- Principal investigator: Gabriele G Armbrecht, MD, PhD — Zentrum für Muskel- und Knochenforschung
- Study coordinator: Irina Lorenz-Meyer
- Email: lorenz-meyer@porous.care
- Phone: +49 176 34448596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.