No-Radiation bone scan could spot fracture risk early
NCT ID NCT06567054
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new ultrasound device that measures bone properties in the lower leg to predict fracture risk in adults over 55. It aims to see if it works as well as or better than standard DXA scans, without using radiation. Researchers will follow 1,600 participants for three years, tracking new fractures and comparing results from both devices.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- POROUS R3C ultrasound device
- What this could lead to
- If successful, this device could offer a safer, radiation-free way to predict fracture risk and catch bone weakness earlier than current methods.
- What could go wrong
- This is an early-stage study with no direct treatment benefit. The device's accuracy compared to DXA is still unproven, and results may not apply to all populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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1,600 people
The number who actually took part.
- Started
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Mar 2025
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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56 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre of Muscle and Bone Research (ZMK), Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, State of Berlin, 12207, Germany
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Department for Orthopedy, Trauma and Reconstructive Surgery, Section of Geriatric Traumatology, University Hospital Halle (Saale)
Halle, 06120, Germany
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Department of Endocrinology, Reproductive Medicine and Osteology Clinic for Gynecology and Obstetrics, University Hospital of Giessen and Marburg
Marburg, 35043, Germany
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Department of Rheumatology, Charité Universitätsmedizin Berlin, Charite Campus Mitte
Berlin, State of Berlin, 10117, Germany
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Division for Endocrinology and Metabolism, Department of Medicine 3, Medical University Vienna
Vienna, 1090, Austria
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VieCuri Medisch Centrum, Department of Internal Medicine, Venlo
Venlo, 5912 BI, Netherlands
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