STUDY PROTOCOL article
Front. Endocrinol.
Sec. Bone Research
Volume 16 - 2025 | doi: 10.3389/fendo.2025.1647800
This article is part of the Research TopicMetabolic and Biomechanical Factors in Bone Fragility: New Frontiers in Understanding and Managing OsteoporosisView all 5 articles
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
Provisionally accepted
Francesca Salamanna1
Silvia Brogini1*
Alberto Di Martino2
Nicola Baldini2
Agostino Gaudio3
Pietro Castellino3
Deyanira Contartese1Chiara Di Censo4
Gianluca Giavaresi1
Cesare Faldini2
Milena Fini2- 1Unit of Surgical Sciences and Technologies, Rizzoli Orthopedic Institute (IRCCS), Bologna, Italy
- 2IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
- 3Universita degli Studi di Catania, Catania, Italy
- 4Universita degli Studi di Bologna, Bologna, Italy
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ABSTRACT Introduction: Osteoporosis (OP) is a growing global public health challenge, often underdiagnosed and underestimated due to limitations in current diagnostic tools such as DXA-based bone mineral density (BMD) assessment and FRAX score. These methods do not fully capture fracture risk nor account for gender-specific and metabolic differences. A novel patented diagnostic method, based on the in vitro behavior of peripheral mononuclear cells (PBMCs) may offer a more accessible, dynamic, and biologically representative approach to OP diagnosis and stratification. Methods and Analysis: This multicenter, double-blind, cross-sectional clinical trial protocol aims to evaluate the diagnostic potential of the PBMC-based test using blood samples (2–5 mL) from 120 participants stratified by BMD (healthy, osteopenic, osteoporotic fractured and non-fractured). PBMCs are isolated and cultured in vitro to assess viability, number, size, and spontaneous osteoclast differentiation over time. Additionally, blood samples are analyzed for T lymphocyte subpopulations, pro-and anti-inflammatory cytokines, platelet-related parameters, and markers of bone turnover. All outcomes are analyzed considering gender differences. Correlation and accuracy analyses will determine the relationship between cellular and biochemical markers and OP status. Ethics and dissemination: The study protocol has been approved by Emilia Romagna's Ethics Committee (CE-AVEC), Bologna, Italy. Written informed consent is obtained from all participants. Findings of this study will be disseminated through peer-reviewed publications and conference presentations. Protocol version June 2024. Trial registration number NCT06551155
Keywords: Osteoporosis, Peripheral mononuclear cells, in vitro diagnostic method, Multicenter clinical trial, study protocol
Received: 16 Jun 2025; Accepted: 22 Sep 2025.
Copyright: © 2025 Salamanna, Brogini, Di Martino, Baldini, Gaudio, Castellino, Contartese, Di Censo, Giavaresi, Faldini and Fini. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Silvia Brogini, silvia.brogini@ior.it
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.