{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T13:40:52Z","timestamp":1740145252307,"version":"3.37.3"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,11,26]],"date-time":"2024-11-26T00:00:00Z","timestamp":1732579200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,11,26]],"date-time":"2024-11-26T00:00:00Z","timestamp":1732579200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"dongkook pharmaceutical Co., Ltd."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Arch Osteoporos"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>\n                           <jats:italic>Summary<\/jats:italic>\n                        <\/jats:title>\n                <jats:p>This study compared liquid and tablet forms of alendronate for osteoporosis treatment. After 12\u00a0months, both forms increased bone density to a similar degree with no significant differences in side effects. New low-volume liquid alendronate is as effective as tablets, offering an alternative treatment option for postmenopausal women with osteoporosis.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Purpose\/Introduction<\/jats:title>\n                <jats:p>Alendronate, despite its significant efficacy, poses challenges due to complex administration protocols and patient compliance issues, underscoring the need for various formulations. This study compared the efficacy and safety of once-weekly low-volume liquid alendronate sodium trihydrate (ALN-S), an oral solution, to once-weekly alendronate sodium (ALN-T), an oral tablet, in Korean postmenopausal women with osteoporosis.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>In a 12-month, multi-center, prospective, randomized, open-labeled, parallel trial conducted at two hospitals in Korea, 170 patients were randomized to alendronate solution (ALN-S) (<jats:italic>N<\/jats:italic>\u2009=\u200985) or alendronate tablet (ALN-T) (<jats:italic>N<\/jats:italic>\u2009=\u200985) groups. The bone mineral density (BMD) of the lumbar spine (LS), femoral neck (FN), and total hip (TH) was measured at baseline and after 12\u00a0months. Bone turnover markers (BTMs) were assessed at baseline, 6, and 12\u00a0months. The primary outcome was the percentage change in BMD of the LS, evaluated for non-inferiority.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>After 12\u00a0months, both ALN-S and ALN-T groups exhibited a significant increase in LS, FN, and TH BMD, with no significant intergroup differences (ALN-S: LS 5.0\u2009\u00b1\u20090.6%, FN 1.8\u2009\u00b1\u20090.6%, TH 2.2\u2009\u00b1\u20090.5%; ALN-T: LS 5.2\u2009\u00b1\u20090.6%, FN 1.6\u2009\u00b1\u20090.6%, TH 1.8\u2009\u00b1\u20090.5%). ALN-S was found to be non-inferior to ALN-T for BMD change at LS (treatment difference:\u2009\u2212\u20090.22%, 95% CI:\u2009\u2212\u20091.84 to 1.40%), excluding the predefined non-inferiority margin of\u2009\u2212\u20092.29%. Changes in BTMs did not differ significantly between groups. The frequency of adverse events was similar between groups.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Liquid alendronate was non-inferior to tablet alendronate in increasing BMD in Korean postmenopausal women with osteoporosis, presenting a viable alternative when the tablet form is limited in various clinical scenarios.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Clinical trial registration<\/jats:title>\n                <jats:p>The trial was registered with ClinicalTrials.gov (NCT05387200).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s11657-024-01480-6","type":"journal-article","created":{"date-parts":[[2024,11,26]],"date-time":"2024-11-26T09:09:09Z","timestamp":1732612149000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and safety of weekly liquid alendronate in Korean postmenopausal women with osteoporosis: a 12-month, multi-center, randomized trial"],"prefix":"10.1007","volume":"19","author":[{"given":"Seungjin","family":"Baek","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seong Hee","family":"Ahn","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Namki","family":"Hong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Da Hea","family":"Seo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seongbin","family":"Hong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4227-5638","authenticated-orcid":false,"given":"Yumie","family":"Rhee","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,11,26]]},"reference":[{"issue":"9773","key":"1480_CR1","doi-asserted-by":"publisher","first-page":"1276","DOI":"10.1016\/S0140-6736(10)62349-5","volume":"377","author":"TD Rachner","year":"2011","unstructured":"Rachner TD, Khosla S, Hofbauer LC (2011) Osteoporosis: now and the future. 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The Yonsei University College of Medicine Ethics Committee and the Institutional Review Board and Ethics Committee of Inha University Hospital approved the study protocol (IRB No. 2021\u201301-018).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Y.R. has received speaker honoraria from Amgen. Y.R. has been an investigator for Amgen, KyowaKirin, Hanmi, Dongkook, DONGAST, and Daewoong. All others declare that they have no conflict of interest.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}}],"article-number":"119"}}