Ten Years of Very Infrequent Zoledronate Therapy in Older Women: An Open-Label Extension of a Randomized Trial.

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dc.contributor.author Grey, Andrew en
dc.contributor.author Horne, Anne en
dc.contributor.author Gamble, Gregory en
dc.contributor.author Mihov, Borislav en
dc.contributor.author Reid, Ian en
dc.contributor.author Bolland, Mark en
dc.date.accessioned 2020-05-06T03:42:28Z en
dc.date.issued 2020-04 en
dc.identifier.issn 0021-972X en
dc.identifier.uri http://hdl.handle.net/2292/50533 en
dc.description.abstract CONTEXT:Intravenous zoledronate prevents bone loss and reduces fracture risk in older adults but the optimal dosing strategy required to achieve each outcome is not known. OBJECTIVE:To assess the effect of very infrequent zoledronate therapy on bone mineral density (BMD) and markers of bone turnover. DESIGN AND PARTICIPANTS:An average of 5.5 years after randomization to either a single dose of 5 mg of zoledronateor placebo, 33 of the original cohort of 50 older women with osteopenia entered a 5-year open-label extension study. SETTING:Academic research center. INTERVENTION:A 5-mg dose of intravenous zoledronate was administered to all participants. MAIN OUTCOME MEASURES:BMD and bone turnover were measured annually, generating data over almost 11 years in women who received 5 mg of zoledronate at 0 and 5.5 years (ZZ, n = 16), or placebo at baseline and 5 mg of zoledronate at 5.5 years (PZ, n = 17). RESULTS:After redosing, BMD in ZZ remained stable, while BMD in PZ increased. At 11 years, changes from baseline BMD in ZZ and PZ were 3.8% (95% confidence interval (CI) 1.1,6.5) and 2.9% (0.3,5.5) at the lumbar spine (P = .61), 0.9% (-1.7,3.5) and -2.8% (-5.3,-0.3) at the total hip (P = .006), and 0.4% (-0.8,1.6) and -0.4% (-1.3,0.5) at the total body (P = .14). Bone turnover markers were similar in the PZ and ZZ groups throughout the 5 years after redosing. CONCLUSIONS:These results suggest that zoledronate 5 mg administered at a 5.5-year interval prevents bone loss over almost 11 years. Clinical trials to investigate whether very infrequent treatment with zoledronate reduces fracture risk are justified. en
dc.format.medium Print en
dc.language eng en
dc.relation.ispartofseries The Journal of clinical endocrinology and metabolism 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 Ten Years of Very Infrequent Zoledronate Therapy in Older Women: An Open-Label Extension of a Randomized Trial. en
dc.type Journal Article en
dc.identifier.doi 10.1210/clinem/dgaa062 en
pubs.issue 4 en
pubs.volume 105 en
dc.rights.holder Copyright: The author en
pubs.publication-status Published en
dc.rights.accessrights http://purl.org/eprint/accessRights/RestrictedAccess en
pubs.subtype Journal Article en
pubs.elements-id 797007 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 1945-7197 en
pubs.record-created-at-source-date 2020-02-05 en
pubs.dimensions-id 32016386 en

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