RECRUITINGINTERVENTIONAL

Clinical Study to Estimate Bone Mineral Density With the POROUS Ultrasound Device

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)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Female or male individuals aged 21 to and including 55 years. - Written willing to sign a consent form has been obtained. Who Should NOT Join This Trial: - Presence of diseases that rule out valid measurements with the DXA and POROUS R4C ultrasound devices (e.g., fractures or metal implants in the examined bones, paralysis of the lower extremities, severe bone abnormalities). - Open wounds or skin infections at the measurement site of the POROUS R4C ultrasound device. - Inability to undergo the investigations required by the Clinical Investigation Plan (CIP) or cognitive limitations that preclude understanding of the Participant Information Sheet and the willing to sign a consent form Document. - Pregnancy and breastfeeding - Individual is in custody by order of an authority or a court of law. - Close affiliation with an investigational site, e.g., employment at an investigational site, close relative of an investigator, or dependent person (e.g., student of the investigational site). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion criteria: * Female or male individuals aged 21 to and including 55 years. * Written informed consent has been obtained. Exclusion criteria: * Presence of diseases that rule out valid measurements with the DXA and POROUS R4C ultrasound devices (e.g., fractures or metal implants in the examined bones, paralysis of the lower extremities, severe bone abnormalities). * Open wounds or skin infections at the measurement site of the POROUS R4C ultrasound device. * Inability to undergo the investigations required by the Clinical Investigation Plan (CIP) or cognitive limitations that preclude understanding of the Participant Information Sheet and the Informed Consent Document. * Pregnancy and breastfeeding * Individual is in custody by order of an authority or a court of law. * Close affiliation with an investigational site, e.g., employment at an investigational site, close relative of an investigator, or dependent person (e.g., student of the investigational site).

Treatments Being Tested

DEVICE

Measurements with the POROUS R4C ultrasound device at the midshaft tibia

The POROUS R4C 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.

DEVICE

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 R4C ultrasound scan.

Locations (2)

Department of Endocrinology and Metabolism, Charité Universitätsmedizin Berlin, Campus Mitte

Berlin, Germany

Centre of Muscle and Bone Research (ZMK), Charité Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, Germany