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In this randomized, open\u2010label study, 118 adults with \u03b2\u2010thalassaemia and bone mineral density (\n                    <jats:styled-content style=\"fixed-case\">BMD<\/jats:styled-content>\n                    )\n                    <jats:italic>Z<\/jats:italic>\n                    scores \u2264\u22122\u00b70 were randomized 1:1\u2013500\u00a0mg calcium with 400 international unis (iu) vitamin\n                    <jats:styled-content style=\"fixed-case\">D<\/jats:styled-content>\n                    daily or 500\u00a0mg calcium with 400\u00a0iu vitamin\n                    <jats:styled-content style=\"fixed-case\">D<\/jats:styled-content>\n                    daily plus neridronate 100\u00a0mg intravenously every 90\u00a0d. Significant increases in\n                    <jats:styled-content style=\"fixed-case\">BMD<\/jats:styled-content>\n                    at the lumbar spine and total hip were noted in the neridronate group at 6 and 12\u00a0months from baseline (\n                    <jats:italic>P<\/jats:italic>\n                    \u00a0&lt;\u00a00\u00b7001), and values were significantly higher than the control group at both time intervals. Neridronate also significantly decreased serum bone alkaline phosphatase and\n                    <jats:styled-content style=\"fixed-case\">C<\/jats:styled-content>\n                    \u2010telopeptide of collagen type 1 levels from as early as 3\u00a0months (\n                    <jats:italic>P<\/jats:italic>\n                    \u00a0=\u00a00\u00b704 and\n                    <jats:italic>P<\/jats:italic>\n                    \u00a0&lt;\u00a00\u00b7001, respectively), reaching significantly lower values at 12\u00a0months compared with the control group (\n                    <jats:italic>P<\/jats:italic>\n                    \u00a0&lt;\u00a00\u00b705). Reductions in back pain and analgesic use were also evident, starting 3\u00a0months from commencing treatment. Treatment was well tolerated by all patients. In this largest randomized trial in thalassaemia\u2010induced osteoporosis to date, neridronate was safe and effective in reducing bone resorption and increasing\n                    <jats:styled-content style=\"fixed-case\">BMD<\/jats:styled-content>\n                    . The associated reduction in back pain and improved quality of life will encourage adherence to therapy. (\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"Clinicaltrials.gov\">Clinicaltrials.gov<\/jats:ext-link>\n                    identifier NCT01140321.)\n                  <\/jats:p>","DOI":"10.1111\/j.1365-2141.2012.09152.x","type":"journal-article","created":{"date-parts":[[2012,5,10]],"date-time":"2012-05-10T06:23:33Z","timestamp":1336631013000},"page":"274-282","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":37,"title":["Neridronate improves bone mineral density and reduces back pain in \u03b2\u2010thalassaemia patients with osteoporosis: results from a phase 2, randomized, parallel\u2010arm, open\u2010label study"],"prefix":"10.1111","volume":"158","author":[{"given":"Gian Luca","family":"Forni","sequence":"first","affiliation":[{"name":"Centro della Microcitemia e delle Anemia Congenite \u2013 Ematologia Ospedale Galliera  Genoa Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silverio","family":"Perrotta","sequence":"additional","affiliation":[{"name":"Department of Paediatrics and Orthopaedics Second University of Naples Naples Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Giusti","sequence":"additional","affiliation":[{"name":"Department of Gerontology and Muscloskeletal Sciences Ospedale Galliera Genoa Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Quarta","sequence":"additional","affiliation":[{"name":"Division of Haematology Presidio Ospedaliero A. 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