Potential usefulness of BMD and bone turnover monitoring of zoledronic acid therapy among women with osteoporosis: Secondary analysis of randomized controlled trial data

Katy J L Bell, Andrew Hayen, Paul Glasziou, Les Irwig, Richard Eastell, Stephanie L. Harrison, Dennis M. Black, Douglas C. Bauer

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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.

Original languageEnglish
Pages (from-to)1767-1773
Number of pages7
JournalJournal of Bone and Mineral Research
Volume31
Issue number9
DOIs
Publication statusPublished - 1 Sep 2016

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zoledronic acid
Bone Remodeling
Osteoporosis
Randomized Controlled Trials
Hip
Spine
Serum
Placebos
Pelvic Bones
Signal-To-Noise Ratio
Therapeutics
Collagen Type I
Proportional Hazards Models
Bone Density
Biomarkers
Incidence
Health
Research

Cite this

Bell, Katy J L ; Hayen, Andrew ; Glasziou, Paul ; Irwig, Les ; Eastell, Richard ; Harrison, Stephanie L. ; Black, Dennis M. ; Bauer, Douglas C. / Potential usefulness of BMD and bone turnover monitoring of zoledronic acid therapy among women with osteoporosis: Secondary analysis of randomized controlled trial data. In: Journal of Bone and Mineral Research. 2016 ; Vol. 31, No. 9. pp. 1767-1773.
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Potential usefulness of BMD and bone turnover monitoring of zoledronic acid therapy among women with osteoporosis: Secondary analysis of randomized controlled trial data. / Bell, Katy J L; Hayen, Andrew; Glasziou, Paul; Irwig, Les; Eastell, Richard; Harrison, Stephanie L.; Black, Dennis M.; Bauer, Douglas C.

In: Journal of Bone and Mineral Research, Vol. 31, No. 9, 01.09.2016, p. 1767-1773.

Research output: Contribution to journalArticleResearchpeer-review

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AU - Bell, Katy J L

AU - Hayen, Andrew

AU - Glasziou, Paul

AU - Irwig, Les

AU - Eastell, Richard

AU - Harrison, Stephanie L.

AU - Black, Dennis M.

AU - Bauer, Douglas C.

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N2 - 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.

AB - 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.

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SN - 0884-0431

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