Measuring bone density using the POROUS ultrasound device
A Cross-sectional, Single-cohort, Bi-centre Clinical Investigation to Estimate Surrogate Bone Mineral Density (BMD) in Young and Middle-aged Men and Women Using Quantitative Ultrasound Imaging (POROUS)
NA · POROUS GmbH · NCT07187518
This study tests whether the POROUS R4C ultrasound can measure bone density in adults aged 21–55 with normal bones, osteopenia, or osteoporosis as an alternative to standard DXA scans.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 21 Years to 55 Years |
| Sex | All |
| Sponsor | POROUS GmbH (industry) |
| Drugs / interventions | radiation |
| Locations | 2 sites (Berlin and 1 other locations) |
| Trial ID | NCT07187518 on ClinicalTrials.gov |
What this trial studies
Adults aged 21 to 55 will undergo bone measurements with the POROUS R4C ultrasound at the midshaft tibia and standard DXA scans of the hip and lumbar spine to compare results. The trial enrolls men and women, excluding those with implants, fractures, skin problems at the measurement site, pregnancy, or inability to consent. The POROUS device provides high-resolution, three-dimensional ultrasound images without ionizing radiation and is portable, which could improve point-of-care access. Results will be compared to DXA-derived areal BMD and clinical risk categories to see how well the ultrasound measurements correspond.
Who should consider this trial
Good fit: Men and women aged 21–55 with normal bone density, osteopenia, or osteoporosis who can give informed consent and have no implants, fractures, or open wounds at the lower-leg measurement site are ideal candidates.
Not a fit: People who are pregnant or breastfeeding, unable to consent, in custody, or who have implants, recent fractures, severe bone abnormalities, or skin problems at the measurement site are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the POROUS device could offer a portable, radiation-free way to get detailed bone assessments at the point of care, potentially improving access to bone health testing.
How similar studies have performed: Quantitative ultrasound methods have shown promise for estimating bone quality, but high-resolution 3D ultrasound devices like the POROUS R4C are newer and less widely validated against DXA.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Female or male individuals aged 21 to and including 55 years. * Written informed consent has been obtained. Exclusion criteria: * Presence of diseases that rule out valid measurements with the DXA and POROUS R4C ultrasound devices (e.g., fractures or metal implants in the examined bones, paralysis of the lower extremities, severe bone abnormalities). * Open wounds or skin infections at the measurement site of the POROUS R4C ultrasound device. * 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 * Individual is in custody by order of an authority or a court of law. * Close affiliation with an investigational site, e.g., employment at an investigational site, close relative of an investigator, or dependent person (e.g., student of the investigational site).
Where this trial is running
Berlin and 1 other locations
- Department of Endocrinology and Metabolism, Charité Universitätsmedizin Berlin, Campus Mitte — Berlin, Germany (RECRUITING)
- Centre of Muscle and Bone Research (ZMK), Charité Universitätsmedizin Berlin, Campus Benjamin Franklin — Berlin, Germany (RECRUITING)
Study contacts
- Principal investigator: Gabriele Armbrecht, MD, PhD — Charite University, Berlin, Germany
- 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.
Conditions: Healthy, Osteopenia, Osteoporosis, Bone Tissue, Diagnostic Imaging, Ultrasound, Ultrasonography, Ultrasonic Diagnosis