{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T18:30:23Z","timestamp":1775068223826,"version":"3.50.1"},"reference-count":17,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2016,6,3]],"date-time":"2016-06-03T00:00:00Z","timestamp":1464912000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2016,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>Denosumab\u2010associated hypocalcaemia (DAH) has been reported in patients with osteoporosis or metastatic bone disease and is associated with stages 4 and 5 chronic kidney disease (CKD, estimated glomerular filtration rate &lt;30\u2009mL\/min\/1.73m<jats:sup>2<\/jats:sup>). Other risk factors for hypocalcaemia have not been fully elucidated.<\/jats:p><jats:p>We aimed to investigate the incidence of hypocalcaemia amongst patients receiving denosumab and to identify clinical features associated with this adverse event.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Retrospective cohort study between June 2013 and June 2014 of patients administered denosumab (60\/120\u2009mg) at a tertiary hospital in Melbourne, Australia, to identify the incidence of an albumin\u2010adjusted serum calcium concentration &lt;2.10\u2009mmol\/L or ionized calcium &lt;1.13\u2009mmol\/L within 6\u2009months of treatment. Univariable and multivariable logistic regression analyses were performed to identify clinical features associated with DAH.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>One hundred and fifty\u2010five patients were administered denosumab (100 osteoporosis, 55 bone metastases). Twenty\u2010two patients (14% [95%CI 9.1\u201320.7]) developed hypocalcaemia: 55% were men, and 55% had osteoporosis. Eighty\u2010six per cent had a 25\u2010hydroxyvitamin D concentration &gt;50\u2009nmol\/L, and 91% were on calcium\/colecalciferol supplementation. Stages 4 and 5 CKD (adjusted odd ratio [aOR] 4.71, 95%CI 1.61\u201313.79, <jats:italic>p<\/jats:italic>\u2009=\u20090.005) and male sex (aOR 4.30, 95%CI 1.69\u201310.96, <jats:italic>p<\/jats:italic>\u2009=\u20090.002) were associated with DAH. No patients were documented as having hypocalcaemic symptoms. One patient received intravenous calcium gluconate treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The incidence of denosumab\u2010associated hypocalcaemia was 14% (95%CI 9.1\u201320.7) within 6\u2009months of treatment despite widespread use of appropriate calcium\/colecalciferol supplementation. Stages 4 and 5 CKD and male sex were associated with subsequent hypocalcaemia. Copyright \u00a9 2016 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.4045","type":"journal-article","created":{"date-parts":[[2016,6,3]],"date-time":"2016-06-03T05:42:53Z","timestamp":1464932573000},"page":"1274-1278","source":"Crossref","is-referenced-by-count":78,"title":["Denosumab\u2010associated hypocalcaemia: incidence, severity and patient characteristics in a tertiary hospital setting"],"prefix":"10.1002","volume":"25","author":[{"given":"Andrew Liem Hieu","family":"Huynh","sequence":"first","affiliation":[{"name":"Department of General Medicine Austin Health  Heidelberg Victoria Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Scott Thomas","family":"Baker","sequence":"additional","affiliation":[{"name":"Department of General Medicine Austin Health  Heidelberg Victoria Australia"},{"name":"Department of Endocrinology Austin Health  Heidelberg Victoria Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew James","family":"Stewardson","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases Austin Health  Heidelberg Victoria Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Douglas Forsyth","family":"Johnson","sequence":"additional","affiliation":[{"name":"Department of General Medicine Austin Health  Heidelberg Victoria Australia"},{"name":"Department of Infectious Diseases Austin Health  Heidelberg Victoria Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,6,3]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1359\/JBMR.040305"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0809493"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)62344-6"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2010.31.3304"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2010.29.7101"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2015.05.016"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/jbmr.1613"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1248\/bpb.b13-00496"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1159\/000380960"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2012.06.019"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/imj.12283"},{"key":"e_1_2_9_13_1","first-page":"213","article-title":"Harmonising adult and paediatric reference intervals in australia and New Zealand: an evidence\u2010based approach for establishing a first panel of chemistry analytes","volume":"35","author":"Tate JR","year":"2014","journal-title":"Clin Biochem Rev"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.5694\/mja11.10301"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/jbmr.403"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1177\/1060028014539919"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/cen.12188"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39582.589433.BE"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.4045","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.4045","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,4]],"date-time":"2023-10-04T00:14:40Z","timestamp":1696378480000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.4045"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,6,3]]},"references-count":17,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2016,11]]}},"alternative-id":["10.1002\/pds.4045"],"URL":"https:\/\/doi.org\/10.1002\/pds.4045","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,6,3]]}}}