Status:
RECRUITING
Clinical Study to Estimate Bone Mineral Density With the POROUS Ultrasound Device
Lead Sponsor:
POROUS GmbH
Collaborating Sponsors:
German Federal Ministry of Education and Research
Conditions:
Healthy
Osteopenia
Eligibility:
All Genders
21-55 years
Phase:
NA
Brief Summary
Osteoporosis is a widespread medical condition among older people. It causes the bones to weaken and become more likely to break. Osteoporosis and bone fracture risk are currently evaluated by looking...
Detailed Description
Medical background and current standard of care: Osteoporosis is defined as a systemic skeletal disease characterized by low mineral bone mass and microarchitectural deterioration of bone tissue (Con...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
November 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 13 2026
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT07187518
Start Date
November 14 2025
End Date
November 13 2026
Last Update
November 20 2025
Active Locations (2)
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1
Department of Endocrinology and Metabolism, Charité Universitätsmedizin Berlin, Campus Mitte
Berlin, Germany, 10117
2
Centre of Muscle and Bone Research (ZMK), Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany, 12203