{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T23:48:39Z","timestamp":1777420119587,"version":"3.51.4"},"reference-count":38,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2023,5,2]],"date-time":"2023-05-02T00:00:00Z","timestamp":1682985600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To review published clinical trial data related to efficacy and safety of administering denosumab at extended dosing intervals for prevention of skeletal-related events (SREs) in cancer patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Sources:<\/jats:title>\n                    <jats:p>A literature search of PubMed was performed (January 2006 to February 2023) using the following search terms: denosumab, bone metastasis, bone lesions, and lytic lesions. Abstracts from conferences, article bibliographies, and product monographs were also reviewed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Selection and Data Extraction:<\/jats:title>\n                    <jats:p>Relevant English-language studies were considered.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Synthesis:<\/jats:title>\n                    <jats:p>Early phase II denosumab trials included treatment arms that utilized extended-interval denosumab, and various retrospective reviews, meta-analyses, and prospective trials have included extended-interval regimens. Most recently, the ongoing randomized REDUSE trial is comparing the efficacy and safety of extended-interval denosumab to standard dosing. At this time, the best available data are restricted to small, randomized trials not designed to compare efficacy and safety of extended-interval denosumab to conventional dosing and did not use consistent endpoints. Furthermore, primary endpoints of available trials largely consisted of surrogate markers of efficacy that may not be reflective of clinical outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Relevance to Patient Care and Clinical Practice:<\/jats:title>\n                    <jats:p>Historically, denosumab has been dosed at 4-week intervals for prevention of SREs. If efficacy is maintained, extending the dosing interval could potentially reduce toxicity, drug cost, and clinic visits compared to every 4-week dosing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>At this time, data demonstrating efficacy and safety of extended-interval denosumab remain limited, and the results of the REDUSE trial are eagerly anticipated to help answer remaining questions.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280231168456","type":"journal-article","created":{"date-parts":[[2023,5,3]],"date-time":"2023-05-03T01:03:11Z","timestamp":1683075791000},"page":"174-184","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["Prevention of Skeletal-Related Events With Extended-Interval Denosumab: A Review of the Literature"],"prefix":"10.1177","volume":"58","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6006-3738","authenticated-orcid":false,"given":"Sidney Veach","family":"Keisner","sequence":"first","affiliation":[{"name":"Department of Pharmacy Practice, College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock, AR, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2023,5,2]]},"reference":[{"key":"bibr1-10600280231168456","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-013-1932-2"},{"key":"bibr2-10600280231168456","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199602223340802"},{"key":"bibr3-10600280231168456","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199612123352401"},{"key":"bibr4-10600280231168456","unstructured":"Novartis. Aredia (pamidronate disodium) injection, for intravenous infusion: US prescribing information; 2012. Accessed April 20, 2022 https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2012\/020036s041lbl.pdf."},{"key":"bibr5-10600280231168456","unstructured":"Novartis. Zometa (zoledronic acid) for injection, for intravenous infusion: US prescribing information; 2018. Accessed April 20, 2022. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/021223s041lbl.pdf."},{"key":"bibr6-10600280231168456","unstructured":"Amgen Inc. Xgeva (Denosumab) injection, for subcutaneous use: US prescribing information; 2021. Accessed April 1, 2022. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/125320s207lbl.pdf."},{"key":"bibr7-10600280231168456","doi-asserted-by":"publisher","DOI":"10.3390\/cells10081978"},{"key":"bibr8-10600280231168456","unstructured":"Amgen Inc. Prolia (Denosumab) injection, for subcutaneous use: US prescribing information; 2021. 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