Bone Abstracts

Introduction : Romosozumab is a monoclonal antibody with dual actions targeting sclerostin. NICE TA791 recommends romosozumab for severe postmenopausal osteoporosis in women with history of major osteoporotic fracture within 24 months. We audited the implementation of romosozumab at Hull University Teaching Hospitals NHS Trust. The objective was to describe baseline characteristics and review discontinuation rates, bone turnover (BTM), densitometry changes and follow on therapy post completion of romosozumab.

Methods : A retrospective observational audit was conducted on patients eligible for romosozumab (NICE TA791) from January 2023 onwards at HUTH. Patients initiated on other therapies or change in clinical status were excluded. Anonymised patient-level data collected from electronic medical records include patient demographics, fracture history, prior bone therapy, pre- and post-treatment P1NP and BMD and follow through bone treatment post romosozumab were entered into a departmental database and statistical analysis performed.

Results : 93 patients were identified eligible for romosozumab. After exclusion criteria, 86 patients were included for final analysis with median age of 734 years (IQR 66.5-77.8), history of multiple fractures (n46, 53.5%) or single fracture (vertebral n37, 43%, hip n1, 1.2%, or other major osteoporotic fracture n2, 2.5%). 44.2% (n38) patients were on prior treatment (bisphosphonates, denosumab, strontium, raloxifene) and 55.8% (n48) were treatment-naive. 98.8% (n 85) patients had baseline densitometry with median T score 3.5 (IQR 4.1 to 2.7) at spine and 2.6 (IQR 3.1 to 2.3) at NOF. 53.5% (n 46) patients completed 12 months of romosozumab with median BMD gain was 15.7% (IQR 10.2-22.6%) at spine and 6.3% (IQR 3.9-8.4%) at NOF. Median P1NP increased from 52 ug/L (IQR 33-75) to 60.47 ug/L (IQR 44-113). 31 patients are on ongoing Romosozumab whereas, 9 patients discontinued due to side effects or change in clinical conditions. 78.2% patients (n 36) had follow-on zoledronic acid (n31) or denosumab (n5) post romosozumab.

Conclusion: The combined anabolic and antiresorptive actions of romosozumab to increase bone mineral density and reduce fracture risk is an unmet need in management of postmenopausal women at high fracture risk. Despite this limited descriptive audit data, appropriate patient selection, shorter treatment course with low discontinuation rate and clinically significant BMD/BTM changes appear to support the use of romosozumab in our routine clinical practice.

Acknowledgements: We would like to acknowledge the help of Dr Ricky Saharia- Consultant physician in Frailty medicine, Mr Matthew Heppell- Advanced Clinical Pharmacist, Medical secretaries- Mrs Maya Sathish, Mrs Terri Welham, Mrs Sally Wilson and Ms Molly Bradshaw, booking staff at Outpatients and DXA technicians at the Centre for Metabolic Bone Disease at Hull University Teaching Hospitals NHS Trust for their continued contribution towards initiation of Romosozumab treatment, data collection and arranging follow ups.