BACKGROUND: Romosozumab is an anti-sclerostin antibody that is used as an anabolic agent for the treatment of osteoporosis. However, due to its novel nature there is only limited data in real-world clinical practice on both BMD and bone turnover markers, the latter of which remain controversial over their clinical utility in evaluating bone metabolism and fracture risk.
AIM: The aim of this study was to review the effectiveness and safety of romosozumab therapy in a single tertiary centre in Western Sydney.
METHODS: We retrospectively reviewed the data from the electronic medical records of 13 patients that started romosozumab treatment at Westmead Hospital between January 2021 to December 2023. 9 patients completed 12 months of therapy, and a further 2 are still undergoing treatment. All patients that completed 12 months of romosozumab had a baseline and post-treatment DEXA, as well as baseline, 3-6 monthly and post-treatment bloods (including bone turnover markers - CTx and P1NP).
RESULTS: 12 months of romosozumab was shown to significantly increase BMD in the lumbar spine by 10.6±7.2% (baseline BMD 0.859±0.150 g/cm2 vs post-treatment BMD 0.952±0.202 g/cm2, p-value 0.004, n=9). Similarly, it significantly increased the T-score at both the lumbar spine (baseline -2.3±1.4 vs post-treatment -1.8±1.6, p-value 0.007, n=9) and total hip (baseline -2.5±0.4 vs post-treatment -2.1±0.4, p-value 0.0005, n=6). Romosozumab led to transient rise in the bone turnover marker P1NP at around 3 months (117.6 ± 42.9% from baseline), that gradually reduced close to baseline by 12 months.
Romosozumab was generally safe, with 2 patients experiencing non-serious injection site reactions and 1 reporting palpitations. One new fracture occurred, and one patient was hospitalized for pre-existing heart failure after completing therapy.
CONCLUSION: Overall, romosozumab significantly increased BMD in osteoporosis patients, demonstrating both efficacy and safety in this real-world clinical setting.