Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device

Condition(s) studied

Investigational drug(s) / intervention(s)

Measurements with the POROUS R3C ultrasound device at the midshaft tibia: The POROUS R3C ultrasound device measures the cortical bone of the midshaft tibia. Ultrasound gel is first applied onto the skin surface, covering the region of interest, followed by placing the ultrasound transducer with a medical ultrasound gel pad placed in front of it. At the marked position on the leg, four technical measurement readings are performed: 2x CortBS and 2x Multifocus, with repositioning the probe between individual measurements, the chronological order of which is not crucial. Scanning time for each measurement takes 1-2 minutes. Out of the four measurements, the two optimal measurements (one for CortBS and one for Multifocus) are selected by the device, based on pre-defined quality criteria.

DXA measurement of the hip and lumbar spine: The following DXA measurements are to be performed: * Spine L1-4 * Hip left * Hip right (alternatively, if a valid measurement of the left hip is not possible) Scanning takes approximately 15 minutes. A maximum number of one repeat measurement is planned (e.g., hip or spine). Note: The DXA scan of the hip is performed on the same side of the body as the POROUS R3C ultrasound scan.

DXA-based Vertebral Fracture Assessment (VFA): DXA-based Vertebral Fracture Assessment (VFA) of thoracic and lumbar spine from T4 to L5.

Projectional radiography of thoracic spine (alternative to DXA-based VFA, if VFA is not available): Projectional radiography of thoracic spine T4-T12 and lumbar spine L1-L5.

Study 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. 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.

Eligibility

Primary outcome measure(s)

• Clinical Endpoint, Part 1 - POROUS-Score based on prevalent fractures — 12 months
  Prevalent fractures are the focus of the analysis in Part 1, i.e., fractures that occurred prior to the Baseline visit. This is reflected in establishing corrected standardized odds ratio (sOR) for the POROUS R3C ultrasound device-derived POROUS-Score. Statistically significant discriminative power of the sOR will be achieved if the lower limit of the 90% confidence interval of the sOR is greater than 1. The POROUS-Score will be evaluated to demonstrate the discriminative performance of the POROUS R3C ultrasound device for prevalent fractures. Outcome measure: POROUS-Score (units on scale)
• Clinical Endpoint, Part 2 - POROUS-Score based on incident fractures — 24 or 36 months
  Incident fractures are the focus of the analysis in Part 2, i.e., fractures that occur after the Baseline visit until the EoS. This is reflected in establishing corrected standardized relative risk (sRR) for the POROUS R3C ultrasound device-derived POROUS-Score. Statistically significant prediction power of the sRR will be achieved if the lower limit of the 90% confidence interval of the sRR is greater than 1. The POROUS-Score will be evaluated to demonstrate the predictive performance of the POROUS R3C ultrasound device for incident fractures. Fractures, which are associated with cortical bone and/or increasing age, will be considered for collecting information on both prevalent and incident fractures. Any incident fractures caused by high-energy external forces will be excluded (censored) from the analysis. Outcome measure: POROUS-Score (units on scale)

Trial sites (6)

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