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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Vitality 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

Первичные конечные точки

• Sensitivity and specificity [Срок оценки: January 2026]

Вторичные конечные точки (1)

• Correlation [Срок оценки: January 2026]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Италия · 2 центра

• Istituto Ortopedico Rizzoli — Bologna
• Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco — Catania

Публикации

• 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
• 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
• 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
• 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
• 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: 10.3 PMID 41113706

Идентификаторы

NCT: NCT06551155 · DISCERN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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