Verifying the effectiveness of romosozumab re-administration on bone mineral density.

Abstract

Upon completing romosozumab therapy for osteoporosis, sequential treatment with other agents is required. However, for patients at high fracture risk despite such therapy, re-administration of romosozumab might be a potent option for subsequent medication to prevent additional fractures. Currently, there is still insufficient real-world clinical data verifying the efficacy of romosozumab re-administration, therefore, this study aimed to evaluate its efficacy. We enrolled 72 osteoporosis patients who remained at high risk of fractures after a 12-month course of romosozumab, followed by sequential therapy either with bisphosphonates, denosumab, or teriparatide. Patients were re-administered another 12-month romosozumab to assess changes in bone mineral density and the percentages of patients achieving a T-score >-2.5 at the completion. Our result exhibited that bone mineral density at the lumbar spine and femoral neck increased significantly through the re-administration phase (P<0.001). The percentage of patients achieving a T-score >-2.5 in the lumbar spine, total hip and femoral neck increased significantly compared to before initial romosozumab therapy, with the greatest improvement seen after re-administration (all P<0.001). Bone formation markers increased significantly (P<0.001) during re-administration, while bone resorption markers showed no significant change (P=0.408). The impact of prior sequential therapy was also evaluated. Bone mineral density increased significantly at all sites for patients who received bisphosphonates as sequential therapy (P<0.05). After denosumab therapy, significant bone mineral density increases were observed only in the lumbar spine (P<0.01), while the total hip and femoral neck showed no significant change. After teriparatide therapy, bone mineral density temporarily decreased during the sequential period but increased significantly after romosozumab re-administration, especially in the lumbar spine and femoral neck (both P<0.001). In conclusion, romosozumab re-administration is an effective treatment. Furthermore, its efficacy varies depending on the sequential therapy used, with the highest effectiveness seen in the order of teriparatide, bisphosphonates, and denosumab.