ABS1165 ANALYSIS OF BONE TURNOVER MARKERS IN PATIENTS TREATED WITH ROMOSOZUMAB IN CLINICAL PRACTICE

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Background: Romosozumab (Rmab) is a novel anti-sclerostin therapy approved for patients at high risk of fracture [1]. Data from real-world clinical practice regarding therapeutic sequences, bone turnover markers (BTMs), densitometric responses, and adverse events remain limited [1]. Objectives: To describe prior therapeutic sequences and their effects on BTMs in patients treated with Rmab in real-world clinical practice, alongside their densitometric response, adverse events, and post-Rmab treatment strategies. Methods: Descriptive observational study. It included patients who had received Rmab for at least 3 months. Clinical data, laboratory results, BTMs, spine X-rays, and bone densitometry measurements were collected. Results: Seventeen postmenopausal women, mean age 70.5±8 years, were included. Of these, 8 completed 12 months (12M) of treatment and 6 completed 6 months (6M). All patients had a history of fragility fractures (median of 2 fractures per patient): 11 vertebral, 6 distal radius, 4 proximal humerus, 3 pelvis, and 2 femur fractures. Regarding prior treatment, 8 patients had received bisphosphonates (BF) (4 zoledronate, 4 alendronate), 4 teriparatide, 3 denosumab (Dmab), and 2 raloxifene. Overall, bone mineral density (BMD) increased: lumbar spine +7.1% and +8.9% at 6M and 12M, respectively; femoral neck +2.2% at both 6M and 12M; and total hip +2.9% and +4.4% at 6M and 12M. Patients previously treated with BF showed greater BMD gains compared to those treated with teriparatide or Dmab, although the differences did not reach statistical significance. The evolution of BTMs varied depending on the prior treatment. Patients previously on BF showed a rise in PINP (+46%) and a decline in CTX by 1 month. Those transitioning from Dmab had marked increases in both markers at 3 months (+1204% and +273%, respectively). In contrast, patients transitioning from teriparatide exhibited a decline in BTMs. During Rmab treatment, 3 patients experienced skin reactions, 1 had an injection site reaction, and 2 developed rhinosinusitis (one case led to Rmab discontinuation). One patient sustained a femoral fracture at 3 months. No new vertebral fractures were reported. After completing 12 months of Rmab, 7 patients initiated Dmab and 1 began intravenous BF therapy. Conclusion: In real-world clinical practice, the prior therapeutic sequence influences both BTM and BMD responses to Rmab. Patients previously treated with BF achieved superior BMD increases compared to those transitioning from teriparatide or Dmab. The BTM behavior suggests a potential "rebound" effect in patients transitioning from Dmab to Rmab. After completing 12 months of Rmab, all patients started antiresorptive therapy. Notably, 35% of patients experienced adverse events, although only one required Rmab discontinuation. REFERENCES: [1] Wu, D., Li, L., Wen, Z. et al. Romosozumab in osteoporosis: yesterday, today and tomorrow. J Transl Med 21, 668 (2023). Acknowledgements: NIL . Disclosure of Interests: None declared . © The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.

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