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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06551155
Acronym
DISCERN
Enrollment
120
Registered
2024-08-13
Start date
2024-08-05
Completion date
2027-02-20
Last updated
2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia, Osteoporosis, Osteoporosis Fracture

Keywords

peripheral blood mononuclear cells, screening, diagnosis

Brief 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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTVitality 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

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER
Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
CollaboratorUNKNOWN

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity and specificityJanuary 2026The primary outcome is to determine the sensitivity and specificity of the in vitro behavior (vitality, number, size, and differentiation) of PBMCs (peripheral blood mononuclear cells) in relation to different levels of bone metabolism alteration (ranging from osteopenia to fragility fractures).

Secondary

MeasureTime frameDescription
CorrelationJanuary 2026The secondary outcomes include the evaluation and correlation of BMD via DXA T-score, vitality, number, size, and differentiation of PBMCs, T lymphocyte subpopulations, pro- and anti-inflammatory factors, platelet-related parameters, and the expression of biochemical markers of bone turnover in blood and serum samples from healthy individuals, as well as from osteopenic and osteoporotic patients (both fractured and non-fractured).

Countries

Italy

Contacts

CONTACTAlberto Corrado Di Martino
albertocorrado.dimartino@ior.it0516366

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026