title: Potential Usefulness of BMD and Bone Turnover Monitoring of Zoledronic Acid Therapy Among Women With Osteoporosis: Secondary Analysis of Randomized Controlled Trial Data.
abstract: We 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. © 2016 American Society for Bone and Mineral Research.
authors.affiliation: The Screening and Diagnostic Test Evaluation Program (STEP), Sydney School of Public Health, The University of Sydney, Sydney, Australia.|Faculty of Health Sciences and Medicine, Bond University, Robina, Australia.
authors.forename: Katy Jl
authors.initials: KJ
authors.lastname: Bell
authors.affiliation: School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Hayen
authors.affiliation: Faculty of Health Sciences and Medicine, Bond University, Robina, Australia.
authors.forename: Paul
authors.initials: P
authors.lastname: Glasziou
authors.affiliation: The Screening and Diagnostic Test Evaluation Program (STEP), Sydney School of Public Health, The University of Sydney, Sydney, Australia.
authors.forename: Les
authors.initials: L
authors.lastname: Irwig
authors.affiliation: Department of Oncology and Metabolism, The University of Sheffield, Sheffield, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Eastell
authors.affiliation: UCSF School of Medicine, UCSF, San Francisco, CA, USA.
authors.forename: Stephanie L
authors.initials: SL
authors.lastname: Harrison
authors.affiliation: UCSF School of Medicine, UCSF, San Francisco, CA, USA.
authors.forename: Dennis M
authors.initials: DM
authors.lastname: Black
authors.affiliation: UCSF School of Medicine, UCSF, San Francisco, CA, USA.
authors.forename: Douglas C
authors.initials: DC
authors.lastname: Bauer
mesh_terms: D015415:Biomarkers / Q000378:metabolism; D015519:Bone Density / Q000187:drug effects*; D016723:Bone Remodeling / Q000187:drug effects*; D004164:Diphosphonates / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007093:Imidazoles / Q000494:pharmacology / Q000627:therapeutic use*; D010024:Osteoporosis / Q000188:drug therapy* / Q000503:physiopathology*; D010919:Placebos; D015203:Reproducibility of Results; D012307:Risk Factors; D000077211:Zoledronic Acid
chemical_list: D015415:Biomarkers; D004164:Diphosphonates; D007093:Imidazoles; D010919:Placebos; D000077211:Zoledronic Acid
keywords: ANTIRESORPTIVES; BIOCHEMICAL MARKERS OF BONE TURNOVER; DXA; FRACTURE PREVENTION; OSTEOPOROSIS