{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,17]],"date-time":"2026-05-17T04:19:47Z","timestamp":1778991587494,"version":"3.51.4"},"reference-count":25,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2013,7,15]],"date-time":"2013-07-15T00:00:00Z","timestamp":1373846400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/3.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2013,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>To describe the rationale and methods for a prospective, open\u2010cohort study assessing the long\u2010term safety of Prolia<jats:sup>\u00ae<\/jats:sup> for treatment of postmenopausal osteoporosis (PMO) in postmarketing settings.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Data will be derived from United States Medicare, United Healthcare, and Nordic (Denmark, Sweden, Norway) national registries. Observation will begin on the date of first Prolia<jats:sup>\u00ae<\/jats:sup> regulatory approval (May 26, 2010) and continue for 10 years. Women with PMO will be identified by postmenopausal age, osteoporosis diagnosis, osteoporotic fracture, or osteoporosis treatment. Exposure to Prolia<jats:sup>\u00ae<\/jats:sup> and bisphosphonates will be updated during follow\u2010up; exposure cohorts will be defined based on patient\u2010years during which patients are on\u2010 or post\u2010treatment. Nine adverse events (AEs) will be assessed based on diagnosis codes: osteonecrosis of the jaw (ONJ), atypical femoral fracture (AFF), fracture healing complications, hypocalcemia, infection, dermatologic AEs, acute pancreatitis, hypersensitivity, and new primary malignancy. Medical review will confirm selected potential cases of ONJ and AFF. Incidence rates (IRs) of AEs will be described overall and for exposure cohorts; multivariate Cox proportional hazard regression models will compare IRs of AEs across exposure cohorts. Utilization patterns of Prolia<jats:sup>\u00ae<\/jats:sup> for approved, and unapproved indications will be described.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This study is based on comprehensive preliminary research and considers methodological challenges specific to the study population. The integrated data systems used in this regulatory committed program can serve as a powerful data resource to assess diverse and rare AEs over time. \u00a9 2013 Amgen Inc. Pharmacoepidemiology and Drug Safety published by John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.3477","type":"journal-article","created":{"date-parts":[[2013,7,16]],"date-time":"2013-07-16T04:54:49Z","timestamp":1373950489000},"page":"1107-1114","source":"Crossref","is-referenced-by-count":23,"title":["Design and methods of a postmarketing pharmacoepidemiology study assessing long\u2010term safety of Prolia<sup>\u00ae<\/sup> (denosumab) for the treatment of postmenopausal osteoporosis"],"prefix":"10.1002","volume":"22","author":[{"given":"Fei","family":"Xue","sequence":"first","affiliation":[{"name":"Center for Observational Research  Amgen Inc., Thousand Oaks CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haijun","family":"Ma","sequence":"additional","affiliation":[{"name":"Global Safety Biostatistics  Amgen Inc., Thousand Oaks CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catherine","family":"Stehman\u2010Breen","sequence":"additional","affiliation":[{"name":"Global Development  Amgen Inc., Thousand Oaks CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christine","family":"Haller","sequence":"additional","affiliation":[{"name":"Global Safety Amgen Inc.  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