{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T14:35:10Z","timestamp":1791815710133,"version":"4.3.4"},"reference-count":36,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2020,6,14]],"date-time":"2020-06-14T00:00:00Z","timestamp":1592092800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>In contrast to randomized clinical trials, comparative safety and effectiveness assessments of osteoporosis medications in clinical practice may be subject to confounding by indication. We used negative control outcomes to detect residual confounding when comparing osteoporosis medications.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Using MarketScan Commercial and Supplemental claims, we identified women aged \u226555\u2009years who initiated an oral bisphosphonate (BP) (risedronate, alendronate, or ibandronate), denosumab (an injected biologic), or intravenous zoledronic acid (ZA) from October 1, 2010 to September 30, 2015. Women with Paget's disease or cancer were excluded. We compared individual oral BPs to each other, denosumab to ZA, denosumab to oral BPs, and ZA to oral BPs, with respect to 11 negative control outcomes identified by subject matter experts. We estimated the 12\u2010month cumulative risk difference (RD) using inverse probability of treatment and censoring weights.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 148\u2009587 women, most initiated alendronate (57%), followed by ibandronate (12%), ZA (11%), risedronate (10%), and denosumab (10%). Compared with denosumab, patients initiating ZA had similar risks of all negative control outcomes. Compared with oral BPs, patients initiating denosumab had a higher risk of a wellness visit (RD = 1.2%, 95% CI: 0.4, 1.9) and a lower risk of receiving herpes zoster vaccine (RD = \u22120.6%, 95% CI: \u22121.1, \u22120.2). Comparing ZA with oral BP initiators resulted in two outcomes with positive associations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Caution is warranted when comparing injectable vs oral osteoporosis medications, given the potential for unmeasured confounding. Evaluating negative control outcomes could be a standard validity check prior to conducting comparative studies.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5037","type":"journal-article","created":{"date-parts":[[2020,6,15]],"date-time":"2020-06-15T01:44:41Z","timestamp":1592185481000},"page":"854-863","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Using negative control outcomes to assess the comparability of treatment groups among women with osteoporosis in the United States"],"prefix":"10.1002","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0312-635X","authenticated-orcid":false,"given":"Leah J.","family":"McGrath","sequence":"first","affiliation":[{"name":"NoviSci, Inc.  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Durham North Carolina USA"},{"name":"Department of Population Health Sciences Duke University  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,6,14]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.med.0000436194.10599.94"},{"issue":"6","key":"e_1_2_9_3_1","first-page":"S164","article-title":"Osteoporosis and the burden of osteoporosis\u2010related fractures","volume":"17","author":"Dempster DW","year":"2011","journal-title":"Am J Manag Care"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/jgs.15585"},{"key":"e_1_2_9_5_1","unstructured":"Fosamax (alendronate sodium) Prescribing Information.https:\/\/www.merck.com\/product\/usa\/pi_circulars\/f\/fosamax\/fosamax_pi.pdfAccessed May 1 2019."},{"key":"e_1_2_9_6_1","unstructured":"Boniva (ibandronate sodium) Tablets Prescribing 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