Clinical chemistry and laboratory medicine · 2026
Personalized reference intervals based on biological variation for serum bone turnover markers in healthy older adults.
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Qin Ye, Zhao Lei, Mu Runqing, Wang Hongyi, Yang Dan, Su Zihan, Wang Xu, Liu Yusi, Zhao Min
Аннотация
OBJECTIVES: The clinical utility of serum bone turnover markers (BTMs) in managing osteoporosis in the elderly is constrained by the absence of personalized reference intervals (prRI) based on biological variation (BV).
METHODS: This longitudinal study tracked monthly serum levels of β-CTX (C-terminal cross-linking telopeptide of type I collagen), procollagen type I N-propeptide (PINP), osteocalcin (OC), parathyroid hormone (PTH), and 25-hydroxyvitamin D (25(OH)D) over six months in 40 healthy elderly participants aged 60-75 years (16 males and 24 females). The study calculated estimates of within-subject BV (CVI), between-subject BV (CVG), within-person BV (CVP), analytical variation (CVA), and reference change values (RCVs).These parameters were subsequently used to establish the personalized reference interval (prRI).
RESULTS: Considerable variability in CVI, CVP, and CVG was observed for BTMs in older adults. Gender differences in baseline concentrations were observed for PINP, OC, and 25(OH)D (p<0.05), but no significant differences were found in BV parameters. Among the markers, OC exhibited the lowest CVI (7.9 %), while β-CTX had the highest (14.8 %). Other markers had CVI values ranging from 11.0 to 14.2 %. RCVs ranged from -19.8 to -33.7 % and 24.6 to 50.8 %. For all five BTMs, the CVI-based prRI ranges were narrower than the popRI, whereas the CVP-based prRIs showed wide inter-individual variation, reflecting substantial heterogeneity in prRIs among older adults.
CONCLUSIONS: This study establishes BV-based prRI for BTMs in older adults, which offers a more clinically relevant interpretation of individual-level data than popRI and facilitates more accurate clinical decision-making.
METHODS: This longitudinal study tracked monthly serum levels of β-CTX (C-terminal cross-linking telopeptide of type I collagen), procollagen type I N-propeptide (PINP), osteocalcin (OC), parathyroid hormone (PTH), and 25-hydroxyvitamin D (25(OH)D) over six months in 40 healthy elderly participants aged 60-75 years (16 males and 24 females). The study calculated estimates of within-subject BV (CVI), between-subject BV (CVG), within-person BV (CVP), analytical variation (CVA), and reference change values (RCVs).These parameters were subsequently used to establish the personalized reference interval (prRI).
RESULTS: Considerable variability in CVI, CVP, and CVG was observed for BTMs in older adults. Gender differences in baseline concentrations were observed for PINP, OC, and 25(OH)D (p<0.05), but no significant differences were found in BV parameters. Among the markers, OC exhibited the lowest CVI (7.9 %), while β-CTX had the highest (14.8 %). Other markers had CVI values ranging from 11.0 to 14.2 %. RCVs ranged from -19.8 to -33.7 % and 24.6 to 50.8 %. For all five BTMs, the CVI-based prRI ranges were narrower than the popRI, whereas the CVP-based prRIs showed wide inter-individual variation, reflecting substantial heterogeneity in prRIs among older adults.
CONCLUSIONS: This study establishes BV-based prRI for BTMs in older adults, which offers a more clinically relevant interpretation of individual-level data than popRI and facilitates more accurate clinical decision-making.