Romosozumab in older adults: real-world patterns in fracture liaison service cohort.

Abstract

Evidence on romosozumab use in very old adults managed in FLS remains limited. In this descriptive real-world cohort, patients receiving romosozumab had a higher baseline fracture risk phenotype than those receiving antiresorptive therapies, reflecting indication-based prescribing in routine care. Monthly romosozumab showed high 12-month scheduled-treatment completion, whereas completion was lower with daily administered teriparatide. These findings, although exploratory, support the use of romosozumab as a practical option for patients at very high risk. To describe baseline treatment-allocation profiles and 12-month scheduled-treatment completion among older adults initiating romosozumab and other osteoporosis therapies in routine fracture liaison service (FLS) care and to explore clinical, functional, laboratory, and densitometric trajectories over follow-up. Retrospective, single-center observational cohort study (Hospital Universitario de Navarra FLS, 2022-2024). Patients at imminent fracture risk (≥ 1 fragility fracture within 24 months before baseline) initiating romosozumab were identified; for each, one patient initiating denosumab, zoledronic acid, and teriparatide was selected by calendar time (same month ± 3 months). Outcomes were assessed at 3 and 12 months. Between-group comparisons used Kruskal-Wallis tests (continuous variables) and Fisher-Freeman-Halton exact tests (categorical variables); when significant, Dwass-Steel-Critchlow-Fligner pairwise tests were performed with Holm-Bonferroni correction. Given the small sample size and non-random treatment allocation, analyses were considered descriptive and hypothesis-generating. Sixty-eight patients were included (n = 17/group). Baseline profiles differed across treatments, consistent with indication-based prescribing; estimated fracture risk (FRAX/QFracture) was higher in anabolic-treated groups. At 12 months, scheduled-treatment completion was 100% among evaluable patients receiving denosumab, romosozumab, and zoledronic acid versus 52.9% with teriparatide; romosozumab versus teriparatide remained significant after Holm adjustment (p = 0.016). Incident fractures and adverse drug reactions were infrequent, and no significant between-group differences were observed in mortality, emergency visits, admissions, falls, fractures, or adverse drug reactions over follow-up. Treatment sequencing at 12 months differed significantly, with heterogeneous post-index regimens after romosozumab and after teriparatide. In this descriptive older adults FLS cohort, romosozumab recipients represented a higher-risk phenotype but showed broadly similar 12-month clinical trajectories compared with other therapies; monthly romosozumab showed high 12-month treatment completion and broadly similar short-term clinical trajectories to other treatment pathways, supporting its use in routine practice. Larger studies are required to determine comparative effectiveness and safety.