{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T03:15:13Z","timestamp":1793502913652,"version":"4.5.0"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2021,5,17]],"date-time":"2021-05-17T00:00:00Z","timestamp":1621209600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["asbmr.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["JBMR Plus"],"published-print":{"date-parts":[[2021,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Upper gastrointestinal (GI) side effects are a main reason for discontinuing bisphosphonate treatment, an important therapeutic option for osteoporosis patients. Consequently, the development of novel formulations with improved tolerability is warranted. In this multicenter prospective, observational, postauthorization safety study conducted in Italy and Spain, postmenopausal women (PMW) with osteoporosis (na\u00efve to bisphosphonates) were treated weekly with a buffered soluble alendronate 70\u2009mg effervescent (ALN\u2010EFF) tablet (Binosto\u00ae) and followed for 12\u2009\u00b1\u20093 months. Information was collected on adverse events (AEs), medication errors, persistence, and compliance using the Morisky\u2010Green questionnaire. Patients (\n                    <jats:italic>N<\/jats:italic>\n                    \u00a0=\u00a01028) aged 67\u2009\u00b1\u20099\u2009years (mean\u2009\u00b1\u2009SD) received ALN\u2010EFF weekly. The cumulative incidence of upper GI AEs (oesophageal toxicity, gastritis, gastric ulcers, and duodenitis) related to ALN\u2010EFF (primary endpoint) was 9.6% (95% confidence interval [CI] 7.9\u201311.6%), the vast majority being of mild intensity. The most frequently occurring upper GI AEs related to ALN\u2010EFF were dyspepsia (2.7%), gastroesophageal reflux disease (2.4%), and nausea (2.2%). None of the relevant upper GI AEs listed in the primary endpoint and no serious AEs were reported. At least one medication error occurred in 29.9% (95% CI 27.1\u201332.8%) of patients. However, the majority of medication errors were associated with administration instructions applicable to any oral bisphosphonate and only seven medication errors were associated with the ALN\u2010EFF formulation. ALN\u2010EFF was discontinued in 209 of 1028 (20.3%) patients. The most frequent reasons for discontinuation were AEs related to ALN\u2010EFF (46.9%) and patients' decision (42.6%). Compliance with ALN\u2010EFF was high, reflected by a mean Morisky\u2010Green score of 92.8\u2009\u00b1\u200918.6. PMW with osteoporosis treated with ALN\u2010EFF in a real\u2010world setting experienced few upper GI AEs. In addition, they had a low discontinuation and high compliance compared with other formulations, suggesting that ALN\u2010EFF may increase patient satisfaction and therefore long\u2010term adherence and efficacy. \u00a9 2021 The Authors.\n                    <jats:italic>JBMR Plus<\/jats:italic>\n                    published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.\n                  <\/jats:p>","DOI":"10.1002\/jbm4.10510","type":"journal-article","created":{"date-parts":[[2021,5,5]],"date-time":"2021-05-05T23:55:51Z","timestamp":1620258951000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["A Prospective Open\u2010Label Observational Study of a Buffered Soluble 70\u2009mg Alendronate Effervescent Tablet on Upper Gastrointestinal Safety and Medication Errors: The\n                    <scp>GastroPASS<\/scp>\n                    Study"],"prefix":"10.1093","volume":"5","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6525-0439","authenticated-orcid":false,"given":"Salvatore","family":"Minisola","sequence":"first","affiliation":[{"name":"Department of Clinical, Internal, Anaesthesiology, and Cardiovascular Sciences Sapienza University of Rome  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio P","family":"Vargas","sequence":"additional","affiliation":[{"name":"SEPAR, S.L. (Private Clinic), Calle Linaje  Malaga Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulia","family":"Letizia Mauro","sequence":"additional","affiliation":[{"name":"Department of Surgical, Oncologic, and Stomatologic Disciplines University of Palermo  Palermo Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando","family":"Bonet Madurga","sequence":"additional","affiliation":[{"name":"MDS 360 (Private Clinic), Chamart\u00edn  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8915-0755","authenticated-orcid":false,"given":"Giovanni","family":"Adami","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Department of Medicine University and Azienda Ospedaliera Universitaria Integrata of Verona  Verona Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5318-7575","authenticated-orcid":false,"given":"Dennis M","family":"Black","sequence":"additional","affiliation":[{"name":"University of California  San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nawab","family":"Qizilbash","sequence":"additional","affiliation":[{"name":"Epidemiology and Risk Management, Oxon Epidemiology  Madrid Spain"},{"name":"Faculty of Epidemiology and Population Health London School of Hygiene and Tropical Medicine  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1633-6396","authenticated-orcid":false,"given":"Josep","family":"Blanch\u2010Rubi\u00f3","sequence":"additional","affiliation":[{"name":"Rheumatology Service Hospital del Mar, Passeig Mar\u00edtim and IMIM (Hospital del Mar Medical Research Institute), Parc de Recerca Biom\u00e8dica de Barcelona  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,5,17]]},"reference":[{"key":"e_1_2_10_2_1","volume-title":"WHO scientific group on the assessment of osteoporosis at primary health care level","author":"Kanis JA","year":"2007"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrdp.2016.69"},{"key":"e_1_2_10_4_1","first-page":"21","article-title":"Osteoporotic fractures: mortality and quality of life","volume":"49","author":"Caliri A","year":"2007","journal-title":"Panminerva Med."},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00198-006-0172-4"},{"key":"e_1_2_10_6_1","unstructured":"National Institute for Health and Care Excellence. 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