Actively Recruiting
Clinical Study to Estimate Bone Mineral Density With the POROUS Ultrasound Device
Led by POROUS GmbH · Updated on 2025-11-20
350
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
POROUS GmbH
Lead Sponsor
G
German Federal Ministry of Education and Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 at clinical risk factors and measuring bone mineral density (BMD). The lower the BMD is, the higher the risk of osteoporotic fractures in the future. An X-ray device called DXA is the main tool used to diagnose osteoporosis and fracture risk clinically. DXA measures two-dimensional BMD in the hip and spine. However, DXA devices are often not readily available at the point of care. The POROUS ultrasound device offers a different approach by measuring various properties of the outer layer of the bone in the lower leg. It has several advantages over DXA: (1) higher and three-dimensional image resolution; (2) the ability to measure bone properties without radiation; (3) portability, it is a mobile medical device; 4) lower operational costs. For this clinical study, we will recruit men and women between the ages of 21 and 55. Most of these study participants will not have evident clinical risks for osteoporosis. The goal for including this age group is to estimate the range of BMD values for younger people before BMD declines with age. In a separate clinical study, we are recruiting older participants. The study is anticipated to last one year. Our major research questions are: * Can the POROUS ultrasound device estimate BMD? * How does its performance compare to DXA? * What is the safety of the new device? The participants will: * answer questions about their medical history. * be measured for height and weight. * be examined with the two devices, DXA and POROUS.
CONDITIONS
Official Title
Clinical Study to Estimate Bone Mineral Density With the POROUS Ultrasound Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male individuals aged 21 to and including 55 years.
- Written informed consent has been obtained.
You will not qualify if you...
- Diseases preventing valid DXA and POROUS measurements, such as fractures, metal implants in examined bones, paralysis of lower limbs, or severe bone abnormalities.
- Open wounds or skin infections at the ultrasound measurement site.
- Inability to participate in required investigations or cognitive limitations affecting understanding of consent.
- Pregnancy or breastfeeding.
- Being in custody by court order.
- Close relationship with investigational site staff, such as employment or being a close relative or dependent.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Department of Endocrinology and Metabolism, Charité Universitätsmedizin Berlin, Campus Mitte
Berlin, Germany, 10117
Actively Recruiting
2
Centre of Muscle and Bone Research (ZMK), Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany, 12203
Actively Recruiting
Research Team
I
Irina Lorenz-Meyer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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