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

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Osteopenia; Osteoporosis; Osteoporosis Fracture

Treatments: Diagnostic Test: Vitality and biological activity of peripheral blood mononuclear cells (PBMCs)

Study type: Observational

Funder types: Other

Identifiers

NCT06551155

DISCERN (Other Identifier)

Details and patient eligibility

About

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.

Full description

Inadequate assessment, diagnosis, and stratification of patients with bone mass loss can lead to an increased risk of osteoporotic fractures. Therefore, alternative and advanced methods to support screening and diagnosis of osteoporosis (OP) are becoming increasingly essential, particularly considering specific gender differences. In this context, evaluating new methods and innovative techniques is a global challenge. To address this challenge, in 2018, the IRCCS Istituto Ortopedico Rizzoli (IOR) filed a European patent (European Patent No. 3008470, March 21, 2018; Inventors: Fini M, Giardino R, Salamanna F) related to an in vitro method for correlating the vitality of peripheral blood mononuclear cells (PBMCs) with bone metabolism alterations and OP through simple optical microscope observation. Additionally, specific gender-related differences have been observed in the number, size, differentiation time, and gene and protein expression profiles of PBMCs from osteoporotic patients of different sexes. In this context, the purpose of this study is to fully expand and develop the patent filed by IRCCS IOR in 2018 in order to: a) improve the understanding of the mechanisms of action and observed behavior in PBMCs on which the IOR patent is based; b) correlate the in vitro behavior of PBMCs with different levels of bone metabolism alteration (from osteopenia to fragility fractures); c) evaluate the correlation between the Dual-X-ray Absorptiometry (DXA) T-score and other blood factors related to OP (parameters related to platelets, pro- and anti-inflammatory cytokines, lymphocyte subpopulations) with the in vitro behavior of PBMCs in the presence of different levels of bone metabolism alteration, considering specific gender differences.

Enrollment: 120 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

120 participants in 4 patient groups

Healthy patients

Description:

Patients with available DXA results, at risk and in periodic follow-up and/or attending outpatient visits for preventive screening

Treatment:

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

Osteopenic patients

Description:

Patients with available DXA results, enrolled during outpatient visits and/or emergency room and/or hospital admissions

Treatment:

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

Non-fractured osteoporotic patients

Description:

Patients with available DXA results, enrolled during outpatient visits and/or emergency room and/or hospital admissions

Treatment:

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

Fractured osteoporotic patients

Description:

Patients with available DXA results or prescribed as per clinical practice, enrolled during hospital admissions

Treatment:

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