Journal of clinical densitometry : the official journal of the International Society for Clinical Densitometry · 2026
Combined baseline P1NP and TRAcP5b classification predicts differential bone mineral density response to romosozumab: A retrospective cohort study of 287 postmenopausal women.
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Nakano Ryo, Ichisawa Ayumi, Saruta Kenya, Kogawa Masakazu, Fukuda Akira
Аннотация
UNLABELLED: Introduction Individual bone turnover markers predict bone mineral density response to romosozumab; however, their combined assessment has not been evaluated. We investigated whether a simple classification based on baseline procollagen type I N-terminal propeptide and tartrate-resistant acid phosphatase 5b levels predicts differential lumbar spine bone mineral density response and fracture risk during romosozumab treatment.
METHODS: This retrospective study analyzed 287 female patients (mean age, 76.9 years) treated with 210 mg monthly romosozumab for 12 months at a single center in Japan (2019-2025). Patients were classified into four groups by baseline procollagen type I N-terminal propeptide and tartrate-resistant acid phosphatase 5b levels above or below the women-only cohort median (59.5 ng/mL and 456 mU/dL, respectively): both high (n = 114), high/low (n = 30), low/high (n = 31), and both low (n = 112). A pre-specified sensitivity analysis used fixed cutoffs from published Japanese premenopausal reference data (65 ng/mL; 440 mU/dL).
RESULTS: Lumbar spine bone mineral density change differed significantly across groups (Kruskal-Wallis p < 0.001). The both-high group showed the highest median gain (+11.0%), with 55.0% achieving > 10% increase, while the both-low group showed the lowest (+6.0%, 19.1% achieving > 10%; pairwise p < 0.001). The fracture rate was 2.6% versus 11.7% (Fisher's exact test, p = 0.009). Multivariate logistic regression confirmed both-high status as an independent predictor of >10% response (odds ratio 3.35, 95% confidence interval 1.71-6.55, p < 0.001) and prior treatment as a negative predictor (odds ratio 0.38, p = 0.003). The sensitivity analysis with fixed cutoffs yielded qualitatively identical results (both-high odds ratio 2.84, 95% confidence interval 1.47-5.48, p = 0.002).
CONCLUSIONS: Combined baseline procollagen type I N-terminal propeptide and tartrate-resistant acid phosphatase 5b classification identified postmenopausal women with differential bone mineral density responses to romosozumab. The concordance between empirical cohort medians and published Japanese premenopausal upper reference limits suggests the classification can be operationalized with fixed, externally derived cutoffs in future studies.
METHODS: This retrospective study analyzed 287 female patients (mean age, 76.9 years) treated with 210 mg monthly romosozumab for 12 months at a single center in Japan (2019-2025). Patients were classified into four groups by baseline procollagen type I N-terminal propeptide and tartrate-resistant acid phosphatase 5b levels above or below the women-only cohort median (59.5 ng/mL and 456 mU/dL, respectively): both high (n = 114), high/low (n = 30), low/high (n = 31), and both low (n = 112). A pre-specified sensitivity analysis used fixed cutoffs from published Japanese premenopausal reference data (65 ng/mL; 440 mU/dL).
RESULTS: Lumbar spine bone mineral density change differed significantly across groups (Kruskal-Wallis p < 0.001). The both-high group showed the highest median gain (+11.0%), with 55.0% achieving > 10% increase, while the both-low group showed the lowest (+6.0%, 19.1% achieving > 10%; pairwise p < 0.001). The fracture rate was 2.6% versus 11.7% (Fisher's exact test, p = 0.009). Multivariate logistic regression confirmed both-high status as an independent predictor of >10% response (odds ratio 3.35, 95% confidence interval 1.71-6.55, p < 0.001) and prior treatment as a negative predictor (odds ratio 0.38, p = 0.003). The sensitivity analysis with fixed cutoffs yielded qualitatively identical results (both-high odds ratio 2.84, 95% confidence interval 1.47-5.48, p = 0.002).
CONCLUSIONS: Combined baseline procollagen type I N-terminal propeptide and tartrate-resistant acid phosphatase 5b classification identified postmenopausal women with differential bone mineral density responses to romosozumab. The concordance between empirical cohort medians and published Japanese premenopausal upper reference limits suggests the classification can be operationalized with fixed, externally derived cutoffs in future studies.