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Peripheral Mononuclear Cells to Screen, Monitor and Stratify the Population at Risk of Osteoporosis and Fractures

Recruitingn/aAges 40 Years - anyAllIstituto Ortopedico Rizzoli
NCT06551155 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Osteoporosis (OP) is one of most common age-associated and chronic metabolic bone diseases, featured by a decrease of bone mineral density (BMD) that increases the risk of bone fractures.OP guidelines agree that Dual-X-ray Absorptiometry (DXA) is the gold standard for BMD assessment, but for the different OP stages screening and diagnosis, BMD by itself is not an accurate predictor. Thus, OP is often misdiagnosed. Aim of the this study is to improve a tool for OP diagnosis based on the ability of circulating peripheral blood mononuclear cells (PBMCs) to maintain or not their in vitro viability (IRCCS Istituto Ortopedico Rizzoli European patent n.3008470 March 21, 2018) for the measurement of the different OP severity levels, also considering specific gender related differences.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Healthy patients (at risk and undergoing periodic follow-up and/or attending outpatient visits for preventive screening) * Osteopenic patients with an available DXA * Osteoporotic patients (fractured and non-fractured) with an available DXA or, for fractured patients, a DXA prescribed as part of clinical practice * Aged ≥ 40 years of both sexes * Body Mass Index (BMI) between 18.5 and 29.9 Exclusion Criteria: * Hematopoietic system disorders (hemolytic, aplastic, and neoplastic anemias) * Coagulation disorders (hereditary or secondary to other disorders) * Infections (including HIV-HBV-HCV positivity) * Neoplastic diseases (primary and/or secondary tumors) * Pregnancy or breastfeeding * Alcohol consumption (\>20 g of alcohol per day currently or in the past) * Smoking (\>10 cigarettes per day, currently or in the past) * Diabetes * Treatment with therapeutic agents that may interfere with hematopoiesis (corticosteroids, immunosuppressive agents, cytotoxic drugs)
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What it tests

  • Vitality and biological activity of peripheral blood mononuclear cells (PBMCs)
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Where

2 sites
Istituto Ortopedico Rizzoli
Bologna, Italy
Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
Catania, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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