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

NCT06551155 | Recruiting

• 1 other identifier: DISCERN
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoporosis; Osteopenia; Osteoporosis Fracture

Keywords

peripheral blood mononuclear cells; screening; diagnosis

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity

  The 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).

  January 2026

Secondary Outcomes (1)

• Correlation

  January 2026

Study Arms (4)

Healthy patients

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

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

Osteopenic patients

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

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

Non-fractured osteoporotic patients

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

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

Fractured osteoporotic patients

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

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

Interventions

Vitality and biological activity of peripheral blood mononuclear cells (PBMCs) DIAGNOSTIC_TEST

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

Fractured osteoporotic patients; Healthy patients; Non-fractured osteoporotic patients; Osteopenic patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy patients (at risk and undergoing periodic follow-up and/or attending outpatient visits for preventive screening), osteopenic patients, and those with osteoporosis (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, with a Body Mass Index (BMI) between 18.5 and 29.9.

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)

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco: collaborator

Study Sites (2)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco

Catania, 95123, Italy

RECRUITING

Related Publications (5)

• Salamanna F, Maglio M, Giavaresi G, Pagani S, Giardino R, Fini M. In vitro method for the screening and monitoring of estrogen-deficiency osteoporosis by targeting peripheral circulating monocytes. Age (Dordr). 2015 Aug;37(4):9819. doi: 10.1007/s11357-015-9819-4. Epub 2015 Aug 7.

  PMID: 26250906 RESULT

• Salamanna F, Maglio M, Borsari V, Giavaresi G, Aldini NN, Fini M. Peripheral Blood Mononuclear Cells Spontaneous Osteoclastogenesis: Mechanisms Driving the Process and Clinical Relevance in Skeletal Disease. J Cell Physiol. 2016 Mar;231(3):521-30. doi: 10.1002/jcp.25134. Epub 2015 Sep 9.

  PMID: 26284737 RESULT

• Salamanna F, Giardino R, Fini M. Spontaneous osteoclastogenesis: Hypothesis for gender-unrelated osteoporosis screening and diagnosis. Med Hypotheses. 2017 Nov;109:70-72. doi: 10.1016/j.mehy.2017.09.028. Epub 2017 Sep 28.

  PMID: 29150298 RESULT

• Salamanna F, Maglio M, Sartori M, Tschon M, Fini M. Platelet Features and Derivatives in Osteoporosis: A Rational and Systematic Review on the Best Evidence. Int J Mol Sci. 2020 Mar 4;21(5):1762. doi: 10.3390/ijms21051762.

  PMID: 32143494 RESULT

• Salamanna F, Brogini S, Di Martino A, Baldini N, Gaudio A, Castellino P, Contartese D, Di Censo C, Giavaresi G, Faldini C, Fini M. Sustainable innovation with a method based on peripheral mononuclear cells to screen, monitor and stratify the population at risk of osteoporosis and fractures - a multicenter cross-sectional trial protocol. Front Endocrinol (Lausanne). 2025 Oct 2;16:1647800. doi: 10.3389/fendo.2025.1647800. eCollection 2025.

  PMID: 41113706 DERIVED

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Osteoporotic Fractures; Disease

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fractures, Bone; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alberto Corrado Di Martino

CONTACT

0516366; albertocorrado.dimartino@ior.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: August 5, 2024
• Primary Completion: January 5, 2026
• Study Completion (Estimated): August 5, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

IT (2)