{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,19]],"date-time":"2025-11-19T11:33:16Z","timestamp":1763551996817},"reference-count":27,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2019,3,28]],"date-time":"2019-03-28T00:00:00Z","timestamp":1553731200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010740","name":"Asahi Kasei Pharma Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100010740","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Once\u2010weekly injection of 56.5\u2010\u03bcg teriparatide formulation is a potent therapeutic agent for osteoporosis treatment. However, this treatment has an issue of difficulty in continuing the treatment by its adverse side effects including nausea, vomiting, and headaches. To reduce these adverse side effects, we conducted a randomized, single\u2010blind, placebo\u2010controlled study to examine the pharmacokinetics, changes in bone turnover markers, and safety profiles of twice\u2010weekly 28.2\u2010\u03bcg teriparatide injections. Different dosing intervals of the twice\u2010weekly 28.2\u2010\u03bcg injections were also studied. A total of 100 healthy Japanese postmenopausal women were enrolled in this multiple\u2010dosing study. The systemic exposure of teriparatide acetate in the twice\u2010weekly 28.2\u2010\u03bcg injection was half that of the once\u2010weekly 56.5\u2010\u03bcg injection. Changes in bone turnover markers in the twice\u2010weekly 28.2\u2010\u03bcg injection were comparable to those in the once\u2010weekly 56.5\u2010\u03bcg injection. Incidences of adverse events including nausea, vomiting, and headaches were lower in the twice\u2010weekly 28.2\u2010\u03bcg injections than those in the once\u2010weekly 56.5\u2010\u03bcg injection. Findings were similar in the twice\u2010weekly 28.2\u2010\u03bcg injections regardless of the dosing interval. Thus, the new dosing regimen using twice\u2010weekly 28.2\u2010\u03bcg injections maintained comparable efficacy to the once\u2010weekly 56.5\u2010\u03bcg injections; however, it improved the safety profile and contributed to better continuity of care with teriparatide.<\/jats:p>","DOI":"10.1002\/cpdd.687","type":"journal-article","created":{"date-parts":[[2019,3,28]],"date-time":"2019-03-28T18:49:23Z","timestamp":1553798963000},"page":"87-96","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Safety Profiles, Pharmacokinetics, and Changes in Bone Turnover Markers After Twice\u2010Weekly Subcutaneous Administration of Teriparatide in Healthy Japanese Postmenopausal Women: A Single\u2010Blind Randomized Study"],"prefix":"10.1002","volume":"9","author":[{"given":"Yuji","family":"Kumagai","sequence":"first","affiliation":[{"name":"Kitasato University East Hospital  Kanagawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Atsushi","family":"Ose","sequence":"additional","affiliation":[{"name":"Development Planning Clinical Development Center Asahi Kasei Pharma Corporation  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kosuke","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Development Planning Clinical Development Center Asahi Kasei Pharma Corporation  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshitsugu","family":"Sugimoto","sequence":"additional","affiliation":[{"name":"Internal Medicine 1 Shimane University Faculty of Medicine  Shimane Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,3,28]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2011-3479"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.5414\/CP202001"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.949"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00198-013-2516-1"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11657-018-0466-0"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-017-0568-x"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s001980050151"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200105103441904"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00774-008-0871-3"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/boneres.2017.2"},{"issue":"3","key":"e_1_2_9_12_1","first-page":"1491","article-title":"PINP as serum marker of metastatic spread to the bone in breast cancer patients","volume":"25","author":"L\u00fcftner D","year":"2005","journal-title":"Anticancer Res"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.77.4.2234"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/jbmr.5650071119"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/47.8.1410"},{"key":"e_1_2_9_16_1","unstructured":"Assessment of fracture risk and its application to screening for postmenopausal osteoporosis. 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