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.
Who can participate
Age range
56 Years – 85 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female or male individuals aged 56 to and including 85 years.
* Written informed consent has been obtained.
Assessment of risk factors for hip and vertebral fractures:
To avoid over- and under-recruiting with regard to the required sample size of participants with ≥ 2-fold increased age-and sex-adjusted risk for hip and vertebral fractures and participants with \< 2-fold increased age- and sex-adjusted risk, clinical risk factors necessary for the calculation of the risk for hip and vertebral fractures (based on the risk calculation scheme outlined in the DVO osteoporosis guideline) are assessed at Screening.
Vertebral fractures:
* Vertebral fracture(s) during the last year
* Vertebral fracture(s) \> 12 months ago
* Number of vertebral fractures
* Maximal severity of vertebral fractures, according to Genant
Hip fractures and other fractures:
* Hip fracture during the last year
* Hip fracture \> 12 months ago
* Humerus fracture
* Pelvic fracture
* Wrist (radius distal) fracture
General risk factors:
* Mother or father with hip fracture, if the participant is under 75 years of age
* Significant alcohol consumption (50 g/day or more)
* Smoking (currently \> 10 cigarettes/day)
* Chronic-obstructive pulmonary disease (COPD)
* Body Mass Index (BMI) ≤ 20
Medication:
* Opioids
* Proton pump inhibitors \> 3 months
* Oral glucocorticoids \> 3 months (prednisone equivalent in mg/d)
Fall-associated risk factors/geriatrics:
* Number of falls within the l…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Endpoint, Part 1 - POROUS-Score based on prevalent fractures
Timeframe: 12 months
2
Clinical Endpoint, Part 2 - POROUS-Score based on incident fractures