Effects of Zoledronate on Cancer, Cardiac Events, and Mortality in Osteopenic Older Women.

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dc.contributor.author Reid, Ian en
dc.contributor.author Horne, Anne en
dc.contributor.author Mihov, Borislav en
dc.contributor.author Stewart, Angela en
dc.contributor.author Garratt, Elizabeth en
dc.contributor.author Bastin, Sonja en
dc.contributor.author Gamble, Gregory en
dc.date.accessioned 2019-11-25T19:30:57Z en
dc.date.issued 2020-01 en
dc.identifier.citation Journal of bone and mineral research: the official journal of the American Society for Bone and Mineral Research 11 Oct 2019 en
dc.identifier.issn 0884-0431 en
dc.identifier.uri http://hdl.handle.net/2292/49168 en
dc.description.abstract We recently showed that zoledronate prevented fractures in older women with osteopenia (hip T-scores between -1.0 and -2.5). In addition to fewer fractures, this study also suggested that women randomized to zoledronate had fewer vascular events, a lower incidence of cancer, and a trend to lower mortality. The present analysis provides a more detailed presentation of the adverse event data from that study, a 6-year, double-blind trial of 2000 women aged >65 years recruited using electoral rolls. They were randomly assigned to receive four infusions of either zoledronate 5 mg or normal saline at 18-month intervals. Supplements of vitamin D, but not calcium, were provided. There were 1017 serious adverse events in 443 participants in the placebo group, and 820 events in 400 participants in those randomized to zoledronate (relative risk = 0.90; 95% CI, 0.81 to 1.00). These events included fractures resulting in hospital admission. Myocardial infarction occurred in 39 women (43 events) in the placebo group and in 24 women (25 events) in the zoledronate group (hazard ratio 0.60 [95% CI, 0.36 to 1.00]; rate ratio 0.58 [95% CI, 0.35 to 0.94]). For a prespecified composite cardiovascular endpoint (sudden death, myocardial infarction, coronary artery revascularization, or stroke) 69 women had 98 events in the placebo group, and 53 women had 71 events in the zoledronate group (hazard ratio 0.76 [95% CI, 0.53 to 1.08]; rate ratio 0.72 [95% CI, 0.53 to 0.98]). Total cancers were significantly reduced with zoledronate (hazard ratio 0.67 [95% CI, 0.51 to 0.89]; rate ratio 0.68 [95% CI, 0.52 to 0.89]), and this was significant for both breast cancers and for non-breast cancers. Eleven women had recurrent or second breast cancers during the study, all in the placebo group. The hazard ratio for death was 0.65 (95% CI, 0.40 to 1.06; p = 0.08), and 0.51 (95% CI, 0.30 to 0.87) in those without incident fragility fracture. These apparent beneficial effects justify further appropriately powered trials of zoledronate with these nonskeletal conditions as primary endpoints. © 2019 American Society for Bone and Mineral Research. en
dc.format.medium Print-Electronic en
dc.language eng en
dc.relation.ispartofseries Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research en
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. en
dc.rights.uri https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm en
dc.title Effects of Zoledronate on Cancer, Cardiac Events, and Mortality in Osteopenic Older Women. en
dc.type Journal Article en
dc.identifier.doi 10.1002/jbmr.3860 en
pubs.issue 1 en
pubs.begin-page 20 en
pubs.volume 35 en
dc.rights.holder Copyright: 2019 American Society for Bone and Mineral Research en
pubs.end-page 27 en
pubs.publication-status Published en
dc.rights.accessrights http://purl.org/eprint/accessRights/RestrictedAccess en
pubs.subtype Research Support, Non-U.S. Gov't en
pubs.subtype Journal Article en
pubs.elements-id 784197 en
pubs.org-id Medical and Health Sciences en
pubs.org-id School of Medicine en
pubs.org-id Medicine Department en
pubs.org-id Science en
pubs.org-id Science Research en
pubs.org-id Maurice Wilkins Centre (2010-2014) en
dc.identifier.eissn 1523-4681 en
pubs.record-created-at-source-date 2019-10-12 en
pubs.dimensions-id 31603996 en

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