RECRUITINGOBSERVATIONAL

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

Identification, Monitoring, and Classification of Patients at Risk of Osteoporosis and Fractures Using a Method Based on the Use of Mononuclear Cells From Peripheral Blood

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

DIAGNOSTIC_TEST

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

Diagnostic test based on the vitality and biological activity of peripheral blood mononuclear cells (PBMCs) tested analyzing approximately 2-5 mL of blood from healthy patients and from osteopenic and osteoporotic (both fractured and non-fractured) patients of both genders

Locations (2)

Istituto Ortopedico Rizzoli

Bologna, Italy

Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco

Catania, Italy