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Peripheral Mononuclear Cells to Screen, Monitor and Stratify the Population at Risk of Osteoporosis and Fractures
Sponsor: Istituto Ortopedico Rizzoli
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2024-08-05
Completion Date
2026-08-05
Last Updated
2025-08-14
Healthy Volunteers
No
Interventions
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