Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device
This study is testing a new ultrasound device called POROUS. It aims to see if POROUS can more accurately predict the risk of bone fractures (breaks) in people over 55 years old, especially those with weak bones. Currently, doctors use a special X-ray called DXA to check bone density, but many breaks still happen in people who don’t seem to have very weak bones. POROUS offers a more detailed, 3D view of bones without using radiation, and might spot changes earlier. Researchers want to compare POROUS with DXA to find out if it can give doctors a better tool to identify people at risk, so they can get treatment sooner and prevent painful fractures.
At a glance
What is this study about?
Imagine your bones are like a house – sometimes, over time, the structure can get a bit weaker, making it more likely for things to break. This is a bit like a condition called osteoporosis, which makes bones fragile and prone to breaking, even from minor bumps. It's quite common in older people.
Currently, doctors often use a special X-ray scan called DXA to measure how strong your bones are. However, it's been found that many people who suffer bone breaks don't always show up as having very weak bones on these scans. This means that many people who could benefit from treatments to protect their bones might not even know they're at risk.
This study is looking at a new device called POROUS, which uses sound waves (ultrasound) instead of X-rays, to get a very detailed picture of your leg bones. It aims to see if POROUS can spot early changes in bone strength and predict fracture risk better than the existing DXA scan. If successful, this new tool could help doctors find more people at risk of fractures much sooner, allowing them to start treatments that could prevent a lot of pain and suffering.
Key takeaways
- This study tests a new ultrasound device (POROUS) for predicting bone breaks.
- It aims to find a better way to identify people at risk of osteoporosis fractures.
- Participants will have scans and regular phone calls for 3 years.
- POROUS uses sound waves, meaning no radiation exposure.
- This research could help improve future bone health diagnosis and treatment.
Who may be eligible?
This study is looking for men and women between the ages of 56 and 85 years old. To join, you'll need to give your informed consent, which means you understand what the study involves and agree to take part.
Researchers will also look at your general health and medical history, including any past bone breaks, certain health conditions like diabetes, or if you take particular medicines. This is because they want to include a mix of people with different risk levels for bone weakening, to get a clear picture of how the new device works for everyone.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 56 and 85 years old?
- Are you happy to provide informed consent?
- Do you have any past bone breaks (like hip, spine, arm, or wrist)?
- Are you able to attend appointments for scans?
- Are you available for phone calls every six months for 3 years?
What does participation involve?
If you decide to take part, you'll first answer some questions about your health and medical history. Your height and weight will be measured, and you'll do a simple physical test. You'll also be checked for any ‘silent’ fractures in your spine, which are breaks that you might not even know you had.
At the beginning and end of the study, which will last about 4 years, you will have scans with both the new POROUS ultrasound device and the standard DXA X-ray device. For 3 years after your initial checks, you'll receive a phone call every six months. During these calls, the researchers will ask if you've had any new bone breaks, if you've started any new medications that might affect your bones, or if your general health has changed.
Potential risks and benefits
Locations (6)
- Division for Endocrinology and Metabolism, Department of Medicine 3, Medical University ViennaVerified postcodeVienna, Austria
- Department of Rheumatology, Charité Universitätsmedizin Berlin, Charite Campus MitteVerified postcodeBerlin, Germany
- Centre of Muscle and Bone Research (ZMK), Charité Universitätsmedizin Berlin, Campus Benjamin FranklinVerified postcodeBerlin, Germany
- Department for Orthopedy, Trauma and Reconstructive Surgery, Section of Geriatric Traumatology, University Hospital Halle (Saale)Verified postcodeHalle, Germany
- Department of Endocrinology, Reproductive Medicine and Osteology Clinic for Gynecology and Obstetrics, University Hospital of Giessen and MarburgVerified postcodeMarburg, Germany
- VieCuri Medisch Centrum, Department of Internal Medicine, VenloVerified postcodeVenlo, Netherlands
Common questions
What is osteoporosis?
Osteoporosis is a condition that makes your bones weaker and more likely to break, even from small bumps or falls. It's common as we get older.
What is the POROUS device?
POROUS is a new ultrasound device that uses sound waves to get a detailed 3D picture of your bones, especially in your lower leg, to see how strong they are.
Will I receive any treatment during the study?
This study is focused on testing a device to predict risk. It does not provide medical treatment, but your GP will still monitor your bone health.
Is the POROUS scan safe?
Yes, the POROUS device uses ultrasound, which is a very safe method that doesn't involve any radiation.
How long does the study last for each participant?
The study involves initial check-ups and follow-up phone calls over a total of 3 years of monitoring, after the initial assessments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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