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

Recruiting now

Conditions studied: Osteoporosis, Osteopenia, Osteoporosis Fracture

In brief

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.

Key facts

Study ID

NCT06551155

Run by

Istituto Ortopedico Rizzoli

People needed

120

Starts

2024-08-05

Expected to finish

2027-02-20

Last updated by the study team

2026-05-28

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Istituto Ortopedico Rizzoli — Bologna, Italy (enrolling)
• Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco — Catania, Italy (enrolling)

Full record on ClinicalTrials.gov

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