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dc.contributor.authorBell, Katy J.L.
dc.contributor.authorHayen, Andrew
dc.contributor.authorIrwig, Les
dc.contributor.authorGlasziou, Paul
dc.contributor.authorEastell, Richard
dc.contributor.authorHarrison, Stephanie L
dc.contributor.authorBlack, Dennis M
dc.contributor.authorBauer, Douglas C
dc.date.accessioned2021-03-03T03:25:48Z
dc.date.available2021-03-03T03:25:48Z
dc.date.issued2016en_AU
dc.identifier.urihttps://hdl.handle.net/2123/24596
dc.description.abstractWe aimed to compare the clinical validity and the detectability of response of short‐term changes in bone mineral density (BMD; hip and spine) and bone turnover markers (serum PINP and CTX) through secondary analysis of trial data. We analyzed data on 7765 women with osteoporosis randomized to 5‐mg once‐yearly infusions of zoledronic acid or placebo in the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly Pivotal Fracture Trial (HORIZON‐PFT; trial ran from 2002 to 2006) and the first extension trial (trial ran from 2006 to 2009). We assessed the clinical validity and detectability of response for 1‐year measurements of the following monitoring tests: total hip and lumbar spine BMD, serum N‐terminal propeptide of type I collagen (sPINP), and serum C‐telopeptide of type I collagen (sCTX; 6‐month measurement used). Clinical validity was assessed by examining prediction of clinical fracture in Cox models; detectability of response to treatment was assessed by the ratio of signal to noise, estimated from the distributions of change in zoledronic acid and placebo groups. Baseline measurements were available for 7683 women with hip BMD, 558 with spine BMD, 1246 with sPINP, and 517 women with sCTX. Hip BMD and sPINP ranked highly for prediction of clinical fracture, whereas sPINP and sCTX ranked highly for detectability of response to treatment. Serum PINP had the highest overall ranking. In conclusion, serum PINP is potentially useful in monitoring response to zoledronic acid. Further research is needed to evaluate the effects of monitoring PINP on treatment decisions and other clinically relevant outcomes.en_AU
dc.language.isoenen_AU
dc.publisherWileyen_AU
dc.relation.ispartofJournal of Bone and Mineral Researchen_AU
dc.rightsCopyright All Rights Reserveden_AU
dc.subjectosteoporosisen_AU
dc.subjectantiresorptivesen_AU
dc.subjectbiochemical markersen_AU
dc.subjectfracture preventionen_AU
dc.titlePotential usefulness of BMD and bone turnover monitoring of zoledronic acid therapy among women with osteoporosis: secondary analysis of randomized controlled trial dataen_AU
dc.typeArticleen_AU
dc.subject.asrc1115 Pharmacology and Pharmaceutical Sciencesen_AU
dc.subject.asrc1117 Public Health and Health Servicesen_AU
dc.identifier.doi10.1002/jbmr.2847
dc.relation.nhmrc1013390
dc.relation.nhmrc527500
dc.relation.nhmrc633003
dc.relation.otherNovartis Pharma, Basel, Switzerland
usyd.facultySeS faculties schools::Faculty of Medicine and Health::Sydney School of Public Healthen_AU
usyd.citation.volume31en_AU
usyd.citation.issue9en_AU
usyd.citation.spage1767en_AU
usyd.citation.epage1773en_AU
workflow.metadata.onlyYesen_AU


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