Actively Recruiting

Phase Not Applicable
Age: 21Years - 55Years
All Genders
Healthy Volunteers
NCT07187518

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

Age: 21Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female or male individuals aged 21 to and including 55 years.
  • Written informed consent has been obtained.
Not Eligible

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

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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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