Objective:

To investigate whether on-treatment changes in bone turnover markers (BTMs) predict 2-year cumulative bone mineral density (BMD) changes after sequential therapy following romosozumab treatment, specifically focusing on ΔP1NP and ΔTRACP-5b.

Approach:

Key Findings:

• ΔP1NP was significantly correlated with the 24-month cumulative LS-BMD change (ρ=−0.375, p<0.0001).
• A greater decline in P1NP during romosozumab treatment predicted greater cumulative BMD gain.
• The optimal ΔP1NP cutoff was −40.3 μg/L (AUC = 0.761; sensitivity=0.545, specificity=0.854).
• Patients in the highest ΔP1NP decline tertile achieved 23.5% cumulative LS-BMD gain versus 12.3% in the lowest tertile (p=0.0003).
• The predictive value was stronger in treatment-naïve patients compared to previously treated patients.
• ΔTRACP-5b showed a similar association (ρ=−0.348, p=0.0001, n=114).

Interpretation:

On-treatment ΔP1NP is an independent predictor of 2-year cumulative BMD after sequential therapy following romosozumab, particularly in treatment-naïve patients.

Limitations:

• Single-center retrospective design.
• Predominantly female Japanese population (96.9%), which may limit generalizability.
• Unvalidated ROC cutoff requiring prospective multicenter validation.

Conclusion:

Monitoring BTM changes during romosozumab treatment may have clinical utility, but further validation through prospective multicenter studies is necessary.

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