{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T10:34:10Z","timestamp":1790678050035,"version":"4.1.0"},"reference-count":52,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,12,12]],"date-time":"2018-12-12T00:00:00Z","timestamp":1544572800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Teijin Pharma Ltd."}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Health Science Reports"],"published-print":{"date-parts":[[2019,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and aims<\/jats:title><jats:p>Clinical data regarding alendronate jelly are limited. We compared the efficacy and safety of once\u2010weekly alendronate oral jelly with once\u2010weekly alendronate tablet formulations in the context of primary osteoporosis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this 6\u2010month, open\u2010label, prospective, observational study, Japanese patients aged \u226560\u00a0years with primary osteoporosis were included from 14 primary care centres in Japan. The effects of once\u2010weekly alendronate oral jelly and tablet formulations on bone mineral density (BMD), bone turnover markers, and quality of life related to gastrointestinal symptoms were assessed at baseline and 6\u00a0months. Treatment was allocated by patient preference. This potentially confounding factor was adjusted for statistically.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 170 patients were enrolled (jelly, n\u00a0=\u00a097; tablet, n\u00a0=\u00a073). Mean percent changes in radius, lumbar spine, femoral neck, and hip BMD were similar in both treatment groups at 6\u00a0months. Both formulations decreased tartrate\u2010resistant acid phosphatase 5b (TRACP\u20105b) and procollagen 1 N\u2010terminal peptide (P1NP) between baseline and 6\u00a0months (by about 50% and 60%, respectively); no significant differences in mean changes were noted in these markers between groups. At 6\u00a0months, no significant differences were noted in visual analogue scale or EuroQOL five\u2010dimension questionnaire scores between groups. The jelly group had significantly lower scores than the tablet group in the Izumo scale domains of heartburn (\u22120.81, <jats:italic>P<\/jats:italic>\u00a0=\u00a00.0040), epigastralgia (\u22120.94, <jats:italic>P<\/jats:italic>\u00a0=\u00a00.0003), and epigastric fullness (\u22120.49, <jats:italic>P<\/jats:italic>\u00a0=\u00a00.044). During treatment, more patients discontinued for upper gastrointestinal symptoms in the tablet group (n\u00a0=\u00a04) than the jelly group (n\u00a0=\u00a01).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Once\u2010weekly alendronate oral jelly 35\u00a0mg may be a suitable alternative therapeutic agent for primary osteoporosis in Japan.<\/jats:p><\/jats:sec>","DOI":"10.1002\/hsr2.107","type":"journal-article","created":{"date-parts":[[2018,12,12]],"date-time":"2018-12-12T13:26:16Z","timestamp":1544621176000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Treatment with once\u2010weekly alendronate oral jelly compared with once\u2010weekly alendronate oral tablet for Japanese patients with primary osteoporosis: An open\u2010label, prospective, observational study"],"prefix":"10.1002","volume":"2","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5323-0350","authenticated-orcid":false,"given":"Nobukazu","family":"Okimoto","sequence":"first","affiliation":[{"name":"Okimoto Clinic  Kure Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukari","family":"Uemura","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Clinical Research Support Center University of Tokyo Hospital  Bunkyo\u2010ku Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toru","family":"Yoshioka","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery Shimura Hospital  Hiroshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinobu","family":"Arita","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery Obase Hospital  Miyako\u2010gun Fukuoka 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