Blood cell test to screen for osteoporosis and fracture risk
Tests whether blood immune cells can flag osteoporosis risk in adults aged 40 and older.
Plain-language title generated from the registry record
Registry title: Peripheral Mononuclear Cells to Screen, Monitor and Stratify the Population at Risk of Osteoporosis and Fractures
Key facts
- Where
- Bologna and Catania, ItalySee the 2 sites
Where in Italy
- Istituto Ortopedico RizzoliBologna, ItalyTaking people
- Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"Catania, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Istituto Ortopedico Rizzoli
- Trial code
- NCT06551155
- Record updated
- 28 May 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Treatment with therapeutic agents that may interfere with hematopoiesis (corticosteroids, immunosuppressive agents, cytotoxic drugs); 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); Diabetes; 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).