{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T01:30:10Z","timestamp":1760146210775,"version":"build-2065373602"},"reference-count":29,"publisher":"MDPI AG","issue":"19","license":[{"start":{"date-parts":[[2024,10,2]],"date-time":"2024-10-02T00:00:00Z","timestamp":1727827200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background\/Objectives: Chronic kidney disease and mineral bone disorders (CKD-MBD) are frequently associated with an increased risk of both vascular calcifications (VCs) and bone fractures (BFs). The complex pathogenesis of VCs and BFs involves various factors such as calcium overload, phosphate imbalance, and secondary hyperparathyroidism. Key players, such as the vitamin K-dependent proteins (VKDPs) matrix Gla protein (MGP) and bone Gla protein (BGP), have pivotal roles both for VCs and BFs. The VIKI study highlighted that hemodialysis patients treated with calcimimetics had higher levels of total BGP and MGP compared to those untreated, suggesting a potential protective effect of these drugs on BFs and VCs beyond the beneficial effect of reducing PTH levels. Methods: ETERNITY-ITA is a multi-center, comparative effectiveness, observational, longitudinal study that will enroll 160 hemodialysis patients (80 patients treated with Etelcalcetide and 80 age- and sex-matched patients treated with calcitriol or vitamin D analogs). Nephrologists will tailor the target dose of Etelcalcetide on an individual level to achieve the KDIGO PTH target. In the Etelcalcetide-treated group, the addition of calcitriol will be allowed when required by clinical practice (for correction of hypocalcemia). Conclusions: This study will evaluate the real-world effect of Etelcalcetide on VKDP levels, such as BGP and MGP, at 3, 9, and 18 months from baseline. The resulting preservation of vascular and bone health will be assessed for the first time by examining aortic and iliac artery calcifications and vertebral fractures, respectively.<\/jats:p>","DOI":"10.3390\/jcm13195888","type":"journal-article","created":{"date-parts":[[2024,10,2]],"date-time":"2024-10-02T06:27:31Z","timestamp":1727850451000},"page":"5888","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Rationale and Protocol of the ETERNITY-ITA Study: Use of Etelcalcetide for Preserving Vitamin K-Dependent Protein Activity\u2014An Italian Study"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9478-4851","authenticated-orcid":false,"given":"Maria","family":"Fusaro","sequence":"first","affiliation":[{"name":"National Research Council (CNR), Institute of Clinical Physiology (IFC), 56124 Pisa, Italy"},{"name":"Department of Medicine, University of Padova, 35128 Padova, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"Aghi","sequence":"additional","affiliation":[{"name":"Independent Researcher, 35128 Padua, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carmela","family":"Marino","sequence":"additional","affiliation":[{"name":"Research Unit of Clinical Epidemiology of Reggio Calabria, Institute of Clinical Physiology (IFC), National Research Council (CNR), 89124 Reggio Calabria, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesca","family":"Mallamaci","sequence":"additional","affiliation":[{"name":"Research Unit of Clinical Epidemiology of Reggio Calabria, Institute of Clinical Physiology (IFC), National Research Council (CNR), 89124 Reggio Calabria, Italy"},{"name":"Nephrology, Dialysis and Transplantation Unit, Grande Ospedale Metropolitano, Bianchi-Melacrino-Morelli (BMM), 89124 Reggio Calabria, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0270-1711","authenticated-orcid":false,"given":"Mario","family":"Plebani","sequence":"additional","affiliation":[{"name":"QI.LAB.MED, Spin-Off of the University of Padova, 35011 Campodarsego, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martina","family":"Zaninotto","sequence":"additional","affiliation":[{"name":"QI.LAB.MED, Spin-Off of the University of Padova, 35011 Campodarsego, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7121-5899","authenticated-orcid":false,"given":"Maria","family":"Grano","sequence":"additional","affiliation":[{"name":"Department of Precision and Regenerative Medicine and Ionian Area, University of Bari, Piazza Giulio Cesare 11, 70124 Bari, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Silvia","family":"Colucci","sequence":"additional","affiliation":[{"name":"Department of Translational Biomedicine and Neuroscience, University of Bari, 70124 Bari, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2011-2160","authenticated-orcid":false,"given":"Maurizio","family":"Gallieni","sequence":"additional","affiliation":[{"name":"Department of Biomedical and Clinical Sciences \u2018Luigi Sacco\u2019, Universita\u0300 di Milano, 20157 Milano, Italy"},{"name":"Post-Graduate School of Specialization in Nephrology, University of Milano, 20157 Milano, Italy"},{"name":"Division of Nephrology and Dialysis, Azienda Socio-Sanitaria Territoriale (ASST) Fatebenefratelli-Sacco, Fatebenefratelli Hospital, 20157 Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas L.","family":"Nickolas","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Nephrology, Columbia University, New York, NY 10032, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0796-9749","authenticated-orcid":false,"given":"Sandro","family":"Giannini","sequence":"additional","affiliation":[{"name":"Department of Medicine, Clinica Medica 1, University of Padova, 35128 Padova, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefania","family":"Sella","sequence":"additional","affiliation":[{"name":"Department of Medicine, Clinica Medica 1, University of Padova, 35128 Padova, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6744-383X","authenticated-orcid":false,"given":"Paolo","family":"Simioni","sequence":"additional","affiliation":[{"name":"Department of Medicine, Clinica Medica 1, University of Padova, 35128 Padova, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alberto","family":"Bazzocchi","sequence":"additional","affiliation":[{"name":"Diagnostic and Interventional Radiology, IRCCS Istituto Ortopedico Rizzoli, 40136 Bologna, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giuseppe","family":"Guglielmi","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, Foggia University School of Medicine, 71122 Foggia, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8342-7434","authenticated-orcid":false,"given":"Fulvia","family":"Taddei","sequence":"additional","affiliation":[{"name":"Bioengineering and Computing Laboratory, IRCCS Istituto Ortopedico Rizzoli, 40136 Bologna, 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