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)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 55
Healthy Volunteers: t
View:

• Female or male individuals aged 21 to and including 55 years.

• Written informed consent has been obtained.

Locations
Other Locations
Germany
Centre of Muscle and Bone Research (ZMK), Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
RECRUITING
Berlin
Department of Endocrinology and Metabolism, Charité Universitätsmedizin Berlin, Campus Mitte
RECRUITING
Berlin
Contact Information
Primary
Irina Lorenz-Meyer
lorenz-meyer@porous.care
+49 176 34448596
Time Frame
Start Date: 2025-11-14
Estimated Completion Date: 2026-11-13
Participants
Target number of participants: 350
Treatments
Experimental: BMD estimation in young and middle-aged men and women
All participants are examined with the investigational device (POROUS R4C ultrasound device) and a comparator device (DXA).
Related Therapeutic Areas
Sponsors
Leads: POROUS GmbH
Collaborators: German Federal Ministry of Education and Research

This content was sourced from clinicaltrials.gov