Actively Recruiting
Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device
Led by POROUS GmbH · Updated on 2025-06-03
1600
Participants Needed
6
Research Sites
230 weeks
Total Duration
On this page
Sponsors
P
POROUS GmbH
Lead Sponsor
E
European Commission
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. However, most bone fractures occur in people who do not have very low BMD values. This means that osteoporosis and fracture risk are often not diagnosed. Many of these non-diagnosed patients would benefit from treatment to reduce the probability of bone fractures. 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. The POROUS ultrasound device measures various properties of the outer layer of the bone in the lower leg. It has several advantages over DXA: (1) its image resolution is higher and three-dimensional; (2) it can detect bone changes without radiation; (3) it can detect these bone changes early and how they change over time. For this clinical study, we will recruit men and women over 55 years old. Most will have clinical risk factors, such as background diseases, for developing osteoporosis. The study is anticipated to last 4 years. Our major research questions are: * Can the POROUS ultrasound device predict fracture risk? * 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, and take a physical test. * be examined for the presence of 'silent' fractures in the spine. * be examined at the beginning and end of the study with the two devices, DXA and POROUS. * be called by telephone every six months and asked if they suffer from new bone fractures, take any medication that might affect their bones, or if their health status has changed. The participants will be monitored for 3 years.
CONDITIONS
Official Title
Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male individuals aged 56 to and including 85 years.
- Written informed consent has been obtained.
- Assessment of clinical risk factors for hip and vertebral fractures based on DVO osteoporosis guidelines.
- Participants with either a \u2265 2-fold or \u003c 2-fold increased age- and sex-adjusted risk for hip and vertebral fractures.
- Ability to be enrolled into age, sex, and risk-based groups as defined by the study.
You will not qualify if you...
- Presence of diseases or conditions that prevent valid DXA or POROUS R3C measurements (e.g., fractures or metal implants in examined bones, paralysis of lower limbs, severe bone abnormalities).
- Inability to undergo required investigations or cognitive limitations preventing understanding of study information and consent.
- Previous medical procedures causing excessive exposure to ionising radiation beyond standard care limits.
- Pregnancy or breastfeeding.
- Participation in other interventional clinical studies currently or within the last three months.
- Being in custody by court order.
- Close affiliation with investigational site staff or relatives.
- Recent or ongoing treatment with bisphosphonates (IV zoledronate within 3 years, oral alendronate, risedronate, or ibandronate within last year if prior treatment exceeded 1 year).
- Treatment with denosumab within last 3 years.
- Hormone replacement therapy or raloxifene within last 6 months.
- Previous or current treatment with anabolic therapies: teriparatide, romosozumab, or abaloparatide.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Division for Endocrinology and Metabolism, Department of Medicine 3, Medical University Vienna
Vienna, Austria, 1090
Actively Recruiting
2
Department of Rheumatology, Charité Universitätsmedizin Berlin, Charite Campus Mitte
Berlin, State of Berlin, Germany, 10117
Actively Recruiting
3
Centre of Muscle and Bone Research (ZMK), Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, State of Berlin, Germany, 12207
Actively Recruiting
4
Department for Orthopedy, Trauma and Reconstructive Surgery, Section of Geriatric Traumatology, University Hospital Halle (Saale)
Halle, Germany, 06120
Actively Recruiting
5
Department of Endocrinology, Reproductive Medicine and Osteology Clinic for Gynecology and Obstetrics, University Hospital of Giessen and Marburg
Marburg, Germany, 35043
Actively Recruiting
6
VieCuri Medisch Centrum, Department of Internal Medicine, Venlo
Venlo, Netherlands, 5912 BI
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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