Eligibility and Uptake of Romosozumab Therapy in High-Risk Older Adults with First Fragility Fractures (#335)
Background: Romosozumab is an osteoanabolic therapy for patients at high risk of osteoporotic fracture. Its use in older adults is limited by cardiovascular safety concerns and practical barriers [1]. This study assessed eligibility for Romosozumab and real-world treatment uptake in geriatric fragility fractures.
Methods: Retrospective cohort study of patients 65 years admitted consecutively with first fragility fracture to an Orthopaedic Geriatrics Unit January-April 2025. Risk stratification was defined by fracture site (Hip or symptomatic vertebral) and Healthy Bones Australia (HBA) criteria.[2] Contraindications were categorised as absolute (myocardial infarction (MI) or stroke <12 months) or relative (MI or stroke >12 months, high cardiovascular risk, renal impairment). Clinical variables included Clinical Frailty Scale (CFS) and nursing home residency. Pharmaceutical Benefit Scheme (PBS) eligibility for Romosozumab required bone-density DEXA T-score thresholds to be met.
Results: Fifty-five patients were identified as high risk. Median age was 84 years (IQR 80-90), with 34 females(66.7%). Absolute contraindications were rare (n=1, 1.8%), while 27 (49.1%) had at least one relative contraindication; prior MI or stroke >12 months (16.7%), high cardiovascular risk (43.7%), renal impairment (1.8%). Males demonstrated higher burden of any contraindication (71.4 vs 35.3%, p=0.009). Frailty (CFS ≥6, 20%) and nursing home residency (18.2%) limited treatment suitability. Sixteen patients (29.1%) merited consideration for Romosozumab. Of these 16, 3 (18.8%) were assessed with DEXA, where 2 (12.5%) met PBS eligibility, and 1 (6.3%) was prescribed therapy. Application of HBA criteria identified 3 additional DEXA studies but no further Romosozumab prescriptions.
Conclusions: In this older adult cohort, prescription contraindications varied by sex and were major considerations in Romosozumab appropriateness. Therapeutic use was less limited by incomplete diagnostic assessment and missed prescription. Future work towards developing a stepwise process to evaluate therapeutic eligibility has the potential to remove barriers limiting the use of Romosozumab in secondary fracture prevention pathways.
- Therapeutic Goods Administration (TGA). New warnings of romosozumab (Evenity) cardiovascular risks [Internet]. Canberra (AUST): TGA; 2023 Dec 7 [cited 2026 Jan 11]. Available from: https://www.tga.gov.au/news/safety-updates/new-warnings-romosozumab-evenity-cardiovascular-risks
- Healthy Bones Australia. Summary Recommendations 2024. Published 2024. Accessed May 31, 2026. https://healthybonesaustralia.org.au/wp-content/uploads/2024/05/summary-recomendations-2024.pdf