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RECRUITINGINTERVENTIONAL

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

A Prospective, Single-cohort, Multicentre Clinical Investigation to Evaluate the Performance of POROUS R3C Ultrasound Device for Fracture Risk Prediction in Middle-aged and Elderly Men and Women

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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. 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 May Be Eligible (Plain English)

Who May Qualify: - Female or male individuals aged 56 to and including 85 years. - Written willing to sign a consent form 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 last year - Chronic hyponatremia - Depression/antidepressants - Anticonvulsants in epilepsy - Immobility (being dependent on a walking aid) - Alzheimer's disease/dementia - Parkinson's disease - Multiple sclerosis - Stroke - Time up and Go Test \> 12 seconds in participants ≥ 70 years of age Endocrinology: - Diabetes mellitus Type I - Diabetes mellitus Type II (including time since onset) - Primary hyperparathyroidism ...See full criteria on ClinicalTrials.gov 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 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 last year * Chronic hyponatremia * Depression/antidepressants * Anticonvulsants in epilepsy * Immobility (being dependent on a walking aid) * Alzheimer's disease/dementia * Parkinson's disease * Multiple sclerosis * Stroke * Time up and Go Test \> 12 seconds in participants ≥ 70 years of age Endocrinology: * Diabetes mellitus Type I * Diabetes mellitus Type II (including time since onset) * Primary hyperparathyroidism * Thyroid-stimulating hormone (TSH) suppression (if yes, including TSH level) Other diseases/medications: * Chronic heart failure * Monoclonal gammopathy of unclear significance (MGUS) * Chronic kidney disease (CKD) stages 3a, 3b, 4 Rheumatology: * Rheumatoid arthritis * Axial spondyloarthritis Exclusion Criteria: * Presence of diseases that rule out valid measurements with the DXA and/or POROUS R3C devices (e.g., fractures or metal implants in the examined bones, paralysis of the lower extremities, severe bone abnormalities). * 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. * Previous medical procedures involving exposure to a cumulative dose of ionising radiation deemed by the Investigator to exceed usual limits within standard of care. * Pregnancy and breastfeeding * Enrolment in any other interventional clinical study (current or during the last three months) * Individual is in custody by order of an authority or a court of law. * Close affiliation with an investigational site, e.g. employed at investigational site, close relative of an investigator, dependent person (e.g. student of the investigational site). Further, individuals who are being or have been treated within the indicated period prior to the beginning of the study with any of the following antiresorptive therapies are excluded from the clinical investigation: * Bisphosphonates (due to residual effects of bisphosphonates after discontinuation): * Intravenous (IV) zoledronate within the last 3 years. * Oral alendronate within the last year, if (continuous) treatment duration before was \> 1 year. * Oral risedronate within the last year, if (continuous) treatment duration before was \> 1 year. * Ibandronate (IV or oral) within the last year, if (continuous) treatment duration before was \> 1 year. * Denosumab within the last 3 years * Hormone replacement therapy (HRT) including combination therapy or oestrogen alone in postmenopausal women within the last 6 months. * Raloxifene within the last 6 months. Individuals who are being or have ever been treated with any of the following anabolic therapies are excluded from the clinical investigation: * Teriparatide * Romosozumab * Abaloparatide.

Treatments Being Tested

DEVICE

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.

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 R3C ultrasound scan.

DEVICE

DXA-based Vertebral Fracture Assessment (VFA)

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

DEVICE

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.

Locations (6)

Division for Endocrinology and Metabolism, Department of Medicine 3, Medical University Vienna
Vienna, Austria
Department of Rheumatology, Charité Universitätsmedizin Berlin, Charite Campus Mitte
Berlin, State of Berlin, Germany
Centre of Muscle and Bone Research (ZMK), Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, State of Berlin, Germany
Department for Orthopedy, Trauma and Reconstructive Surgery, Section of Geriatric Traumatology, University Hospital Halle (Saale)
Halle, Germany
Department of Endocrinology, Reproductive Medicine and Osteology Clinic for Gynecology and Obstetrics, University Hospital of Giessen and Marburg
Marburg, Germany
VieCuri Medisch Centrum, Department of Internal Medicine, Venlo
Venlo, Netherlands