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RECRUITING
NCT06551155

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

Sponsor: Istituto Ortopedico Rizzoli

View on ClinicalTrials.gov

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

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