{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T10:58:51Z","timestamp":1740135531363,"version":"3.37.3"},"reference-count":31,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,3,3]],"date-time":"2022-03-03T00:00:00Z","timestamp":1646265600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,3,3]],"date-time":"2022-03-03T00:00:00Z","timestamp":1646265600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Endocr Disord"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>In adult population, Growth Hormone Deficiency (GHD) is a complex clinical condition with heterogeneity of causes and duration. Growth Hormone (GH) replacement therapy has beneficial effects entailing a chronic and expensive use. Therefore, entity, appropriateness and standardization of GHD treatment need to be accurately analysed.<\/jats:p>\n                <jats:p>In Italy, the epidemiological surveillance on somatropin therapy is entrusted to the National Register of Growth Hormone Therapy (Registro Nazionale degli Assuntori dell\u2019Ormone della Crescita-RNAOC) by the Italian Regulation, in accordance of which the RNAOC-database is collecting the notifications of somatropin prescriptions.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Aim of this study is to analyse data on somatropin-treated adult population communicated to the RNAOC by the specialist centres of 15 Italian regions and 2 autonomous provinces.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>From 2011 to 2019, the somatropin-treated adults were 970 with 4061 examinations (1.21\u2009\u00b1\u20090.33 visits\/year).<\/jats:p>\n                <jats:p>The diagnoses were: hypopituitarism (n\u2009=\u2009579); hypophysectomy (n\u2009=\u2009383); and congenital GHD (n\u2009=\u20093). Five subjects were addressed with diagnoses not included in the regulation.<\/jats:p>\n                <jats:p>The starting posology of somatropin was 0.320 (\u00b1\u20090.212) mg\/day, 0.292 (\u00b1\u20090.167) mg\/day in male and 0.360 (\u00b1\u20090.258) in female patients, with 7 administrations\/week in 70.31% of the prescriptions. The differences in posology by gender persisted at 10th year of the follow-up. Starting dosage was higher in patients diagnosed with adult GHD before the age of 30 (0.420\u2009\u00b1\u20090.225\u00a0mg\/day), with a progressive decrease of the dosage during the follow-up.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>This is the first report on adult GH treatment, describing numbers, diagnoses, and pharmaceutical prescriptions associated to somatropin therapy in a large cohort of Italian GHD-adults.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12902-022-00960-5","type":"journal-article","created":{"date-parts":[[2022,3,3]],"date-time":"2022-03-03T13:05:54Z","timestamp":1646312754000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Somatropin therapy in italian adults with growth hormone deficiency"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1877-4376","authenticated-orcid":false,"given":"Flavia","family":"Pricci","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniela","family":"Rotondi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2944-5444","authenticated-orcid":false,"given":"Marika","family":"Villa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arianna","family":"Valerio","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elvira","family":"Agazio","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paolo","family":"Roazzi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,3,3]]},"reference":[{"key":"960_CR1","unstructured":"Klose UFeldt-Rasmussen,M, Adult Growth Hormone Deficiency Clinical Management. Feingold KR, Anawalt B, Boyce A et al, editors. Endotext [Internet]. South Dartmouth (MA). MDText.com, Inc.; 2000-."},{"issue":"2","key":"960_CR2","doi-asserted-by":"publisher","first-page":"382","DOI":"10.1210\/jcem.83.2.4594","volume":"83","author":"PV Carroll","year":"1998","unstructured":"Carroll PV, Christ ER, Bengtsson BA, Carlsson L, Christiansen JS, Clemmons D, Hintz R, Ho K, Laron Z, Sizonenko P, S\u00f6nksen PH, Tanaka T, Thorne M. Growth hormone deficiency in adulthood and the effects of growth hormone replacement: a review. Growth Hormone Research Society Scientific Committee. J Clin Endocrinol Metab. 1998;83(2):382\u201395.","journal-title":"J Clin Endocrinol Metab"},{"issue":"11","key":"960_CR3","doi-asserted-by":"publisher","first-page":"4219","DOI":"10.1210\/jc.2013-2415","volume":"98","author":"EM Erfurth","year":"2013","unstructured":"Erfurth EM. Update in mortality in GH-treated patients. J Clin Endocrinol Metab. 2013;98(11):4219\u201326.","journal-title":"J Clin Endocrinol Metab"},{"issue":"2","key":"960_CR4","doi-asserted-by":"publisher","first-page":"405","DOI":"10.1016\/j.ecl.2016.01.005","volume":"45","author":"R Lanes","year":"2016","unstructured":"Lanes R. Cardiovascular Risk in Growth Hormone Deficiency: Beneficial Effects of Growth Hormone Replacement Therapy. Endocrinol Metab Clin North Am. 2016;45(2):405\u201318.","journal-title":"Endocrinol Metab Clin North Am"},{"key":"960_CR5","unstructured":"Italia. Determinazione dell\u2019Agenzia Italiana del Farmaco 29 ottobre 2004. Note AIFA 2004. Revisione delle Note CUF. Gazzetta Ufficiale n. 259 del 04 novembre 2004, Suppl. Ordinario n. 162."},{"key":"960_CR6","unstructured":"Italia. Note AIFA 2006\u20132007 per l\u2019uso appropriato dei farmaci. Gazzetta Ufficiale - Supplemento Ordinario n. 7 del 10 gennaio 2007."},{"key":"960_CR7","unstructured":"Italia. Determinazione dell\u2019Agenzia del Farmaco 22 settembre 2009. Modifica alla Nota AIFA 39. Gazzetta Ufficiale - Serie Generale n. 238 del 13 ottobre 2009."},{"key":"960_CR8","unstructured":"Italia. Determinazione dell\u2019Agenzia Italiana del Farmaco 19 giugno 2014. Modifica alla Nota AIFA 39. Gazzetta Ufficiale - Serie Generale n. 154 del 5 luglio 2014."},{"key":"960_CR9","unstructured":"Italia. Decreto del Presidente del Consiglio dei Ministri del 3 marzo 2017. \u201cIdentificazione dei sistemi di sorveglianza e dei registri di mortalit\u00e0, di tumori e di altre patologie\u201d. Gazzetta Ufficiale - Serie Generale n. 109 del 12 maggio 2017."},{"issue":"7","key":"960_CR10","doi-asserted-by":"publisher","first-page":"769","DOI":"10.1007\/s40618-018-0980-3","volume":"42","author":"F Pricci","year":"2019","unstructured":"Pricci F, Villa M, Maccari F, Agazio E, Rotondi D, Panei P, Roazzi P. The Italian Registry of GH Treatment: electronic Clinical Report Form (e-CRF) and web-based platform for the national database of GH prescriptions. J Endocrinol Invest. 2019;42(7):769\u201377.","journal-title":"J Endocrinol Invest"},{"key":"960_CR11","doi-asserted-by":"publisher","unstructured":"Marcian\u00f2 I, Ingrasciotta Y, Giorgianni F, Ientile V, Chinellato A, Tari DU, Gini R, Cannav\u00f2 S, Pastorello M, Scondotto S, Cananzi P, Traversa G, Trotta F, Belleudi V, Addis A, Trifir\u00f2 G. Pattern of Use of Biosimilar and Originator Somatropin in Italy: A Population-Based Multiple Databases Study During the Years 2009\u20132014. Front Endocrinol (Lausanne). 2018;9:95. doi: https:\/\/doi.org\/10.3389\/fendo.2018.00095. eCollection 2018.","DOI":"10.3389\/fendo.2018.00095"},{"key":"960_CR12","doi-asserted-by":"publisher","first-page":"392","DOI":"10.1210\/jc.2008-0713","volume":"94","author":"SM Webb","year":"2009","unstructured":"Webb SM, Strasburger CJ, Mo D, Hartman ML, Melmed S, Jung H, Blum WF, Attanasio AF. Changing patterns of the adult growth hormone deficiency diagnosis documented in a decade-long global surveillance database. J Clin Endocrinol Metab. 2009;94:392\u20139. (doi:https:\/\/doi.org\/10.1210\/jc.2008-0713).","journal-title":"J Clin Endocrinol Metab"},{"key":"960_CR13","doi-asserted-by":"publisher","first-page":"703","DOI":"10.1046\/j.1365-2265.1999.00695.x)","volume":"50","author":"R Abs","year":"1999","unstructured":"Abs R, Bengtsson BA, Hernberg-Stahl E, Monson JP, Tauber JP, Wilton P, Wuster C. GH replacement in 1034 growth hormone deficient hypopituitary adults: demographic and clinical characteristics, dosing and safety. Clin Endocrinol. 1999;50:703\u201313. (doi:https:\/\/doi.org\/10.1046\/j.1365-2265.1999.00695.x).","journal-title":"Clin Endocrinol"},{"key":"960_CR14","doi-asserted-by":"publisher","first-page":"90","DOI":"10.1002\/pds.1510","volume":"17","author":"LP Gutierrez","year":"2008","unstructured":"Gutierrez LP, Koltowska-Haggstrom M, Jonsson PJ, Mattsson AF, Svensson D, Westberg B, Luger A. Registries as a tool in evidencebased medicine: example of KIMS (Pfizer International Metabolic Database). Pharmacoepidemiol Drug Saf. 2008;17:90\u2013102. (doi:https:\/\/doi.org\/10.1002\/pds.1510).","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"960_CR15","doi-asserted-by":"publisher","first-page":"1600","DOI":"10.1210\/jc.87.4.1600)","volume":"87","author":"AF Attanasio","year":"2002","unstructured":"Attanasio AF, Bates PC, Ho KK, Webb SM, Ross RJ, Strasburger CJ, Bouillon R, Crowe B, Selander K, Valle D, Lamberts SW. Humna growth hormone replacement in adult hypopituitary patients: long-term effects on body composition and lipid status \u2013 3-year results from the HypoCCS Database. J Clin Endocrinol Metab 2002 87 1600\u20136. (doi:10. 1210\/jc.87.4.1600).","journal-title":"J Clin Endocrinol Metab"},{"key":"960_CR16","doi-asserted-by":"publisher","first-page":"61","DOI":"10.1530\/eje.1.02191","volume":"155","author":"K Stochholm","year":"2006","unstructured":"Stochholm K, Gravholt CH, Laursen T, J\u00f8rgensen JO, Laurberg P, Andersen M, Kristensen L, Feldt-Rasmussen U, Christiansen JS, Frydenberg M, Green A. Incidence of GH deficiency \u2013 a nationwide study. Eur J Endocrinol. 2006;155:61\u201371.","journal-title":"Eur J Endocrinol"},{"issue":"4","key":"960_CR17","doi-asserted-by":"publisher","first-page":"491","DOI":"10.1530\/EJE-10-0914","volume":"164","author":"IC van Nieuwpoort","year":"2011","unstructured":"van Nieuwpoort IC, van Bunderen CC, Arwert LI, Franken AA, Koppeschaar HP, van der Lelij AJ, Twisk JW, Boers M, Drent ML. Dutch National Registry of GH Treatment in Adults: patient characteristics and diagnostic test procedures. Eur J Endocrinol. 2011;164(4):491\u20137.","journal-title":"Eur J Endocrinol"},{"key":"960_CR18","doi-asserted-by":"crossref","unstructured":"Schneider HJ, Aimaretti G, Kreitschmann-Andermahr I, Stalla GK, Ghigo E. Hypopituitarism. Lancet. 2007;369(9571):1461\u20131470.","DOI":"10.1016\/S0140-6736(07)60673-4"},{"key":"960_CR19","doi-asserted-by":"publisher","first-page":"335","DOI":"10.1038\/nrendo.2013.77","volume":"9","author":"AY Kargi","year":"2013","unstructured":"Kargi AY, Merriam GR. Diagnosis and treatment of growth hormone deficiency in adults. Nat Rev Endocrinol. 2013;9:335\u201345.","journal-title":"Nat Rev Endocrinol"},{"key":"960_CR20","doi-asserted-by":"publisher","unstructured":"Cook DM, Yuen KC, Biller BM, Kemp SF, Vance ML. American Association of Clinical American Association of Clinical Endocrinologists medical guidelines for clinical practice for growth hormone use in growth hormone-deficient adults and transition patients \u2013 2009 update.Endocr Pract. 2009;15Suppl 2:1\u201329. doi: https:\/\/doi.org\/10.4158\/EP.15.S2.1.","DOI":"10.4158\/EP.15.S2.1"},{"key":"960_CR21","doi-asserted-by":"publisher","unstructured":"Martel-Duguech LM, Jorgensen JOL, Korbonits M, et al. ESE audit on management of Adult Growth Hormone Deficiency in clinical practice. Eur J Endocrinol. 2020: EJE-20-1180.R1. doi: https:\/\/doi.org\/10.1530\/EJE-20-1180. Online ahead of print.","DOI":"10.1530\/EJE-20-1180"},{"issue":"6","key":"960_CR22","doi-asserted-by":"publisher","first-page":"735","DOI":"10.1046\/j.1365-2265.2001.01406.x","volume":"55","author":"M Regal","year":"2001","unstructured":"Regal M, P\u00e1ramo C, Sierra SM, Garcia-Mayor RV. Prevalence and incidence of hypopituitarism in an adult Caucasian population in northwestern Spain. Clin Endocrinol (Oxf). 2001;55(6):735\u201340.","journal-title":"Clin Endocrinol (Oxf)"},{"key":"960_CR23","doi-asserted-by":"publisher","first-page":"595","DOI":"10.1530\/eje.0.1410595","volume":"141","author":"G Sassolas","year":"1999","unstructured":"Sassolas G, et al. GH deficiency in adults: an epidemiological approach. Eur J Endocrinol. 1999;141:595\u2013600.","journal-title":"Eur J Endocrinol"},{"key":"960_CR24","doi-asserted-by":"publisher","unstructured":"Tanriverdi F, Kelestimur F. Classical and non-classical causes of GH deficiency in adults Best Pract Res Clin Endocrinol Metab. 2017;31(1):3\u201311. doi: https:\/\/doi.org\/10.1016\/j.beem.2017.02.001. Epub 2017 Feb 23.PMID: 28477730.","DOI":"10.1016\/j.beem.2017.02.001"},{"issue":"1","key":"960_CR25","doi-asserted-by":"publisher","first-page":"S25","DOI":"10.1530\/EJE-09-0273","volume":"161","author":"G Brabant","year":"2009","unstructured":"Brabant G, Poll EM, Jonsson P, et al. Etiology, baseline characteristics, and biochemical diagnosis of GH deficiency in the adult: are there regional variations? Eur J Endocrinol. 2009;161 Suppl 1:S25\u201331.","journal-title":"Eur J Endocrinol"},{"issue":"6","key":"960_CR26","doi-asserted-by":"publisher","first-page":"1587","DOI":"10.1210\/jc.2011-0179","volume":"96","author":"ME Molitch","year":"2011","unstructured":"Molitch ME, Clemmons DR, Malozowski S, Merriam GR, Vance ML. Endocrine Society. Evaluation and treatment of adult growth hormone deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011;96(6):1587\u2013609.","journal-title":"J Clin Endocrinol Metab"},{"issue":"11","key":"960_CR27","doi-asserted-by":"publisher","first-page":"1191","DOI":"10.4158\/GL-2019-0405","volume":"25","author":"KCJ Yuen","year":"2019","unstructured":"Yuen KCJ, Biller BMK, Radovick S, Carmichael JD, Jasim S, Pantalone KM, Hoffman AR. American Association of Clinical Endocrinologists and American College of Endocrinology guidelines for management of growth hormone deficiency in adults and patients transitioning from paediatric to adult care. Endocr Pract. 2019;25(11):1191\u2013232.","journal-title":"Endocr Pract"},{"key":"960_CR28","doi-asserted-by":"crossref","unstructured":"Ken KY, Ho. 2007 GH Deficiency Consensus Workshop Participants. Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II: a statement of the GH Research Society in association with the European Society for Pediatric Endocrinology, Lawson Wilkins Society, European Society of Endocrinology, Japan Endocrine Society, and Endocrine Society of Australia. Eur J Endocrinol 2007;157(6):695\u2013700.","DOI":"10.1530\/EJE-07-0631"},{"key":"960_CR29","doi-asserted-by":"publisher","unstructured":"Gasco V, Prodam F, Grottoli S, Marzullo P, Longobardi S, Ghigo E, Aimaretti G. GH therapy in adult GH deficiency: a review of treatment schedules and the evidence for low starting doses Eur J Endocrinol 2013;168(3):R55-66. doi: https:\/\/doi.org\/10.1530\/EJE-12-0563. Print 2013 Mar.","DOI":"10.1530\/EJE-12-0563"},{"key":"960_CR30","doi-asserted-by":"crossref","unstructured":"Boguszewski CL. Update on GH therapy in adults F1000Res. 2017;6:2017.","DOI":"10.12688\/f1000research.12057.1"},{"key":"960_CR31","unstructured":"Italian Medicines Agency. National Report on Medicines Use in Italy. Available from: https:\/\/www.aifa.gov.it\/en\/rapporti-osmed."}],"container-title":["BMC Endocrine Disorders"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12902-022-00960-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12902-022-00960-5\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12902-022-00960-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,3,3]],"date-time":"2022-03-03T13:07:42Z","timestamp":1646312862000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcendocrdisord.biomedcentral.com\/articles\/10.1186\/s12902-022-00960-5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,3,3]]},"references-count":31,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2022,12]]}},"alternative-id":["960"],"URL":"https:\/\/doi.org\/10.1186\/s12902-022-00960-5","relation":{},"ISSN":["1472-6823"],"issn-type":[{"type":"electronic","value":"1472-6823"}],"subject":[],"published":{"date-parts":[[2022,3,3]]},"assertion":[{"value":"20 May 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 February 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 March 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.The data collection procedures from clinical units to the RNAOC are in agreement with the Italian legislation for the personal data protection (Legislative Decree 196\/2003) and have been updated according to the current European regulation (General Data Protection Regulation, GDPR 2016\/679).This observational study is included in the Register of Data Treatments of the National Institute of Health (Istituto Superiore di Sanit\u00e0).Informed consent is not required because processing personal data is essential in order to carry out surveillance activities and drug reimbursement. Anyway, to ensure compliance with the GDPR, an information notice for patients is available in the RNAOC-web platform, with the description of personal data treatment in terms of objective, methods, and ownership. For the retrospective study, formal consent is not required.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethic approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no conflict of interest.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"52"}}