Real-world safety and effectiveness of romosozumab following daily or weekly administration of teriparatide in primary and secondary osteoporosis

Abstract

Romosozumab is an anti-sclerostin antibody that increases bone formation and decreases bone resorption, and it became available for patients at high risk of osteoporotic fractures in Japan in 2019. The aim of this study was to clarify the clinical effects, safety, and predictors of the effectiveness of 12 months of romosozumab therapy following daily or weekly administration of teriparatide. The study had an observational pre-post design and included 171 female patients. Romosozumab was administered at a dose of 210 mg subcutaneously every 4 weeks for 12 months following daily or weekly administration of teriparatide. The incidence of new fractures, safety, and changes in bone mineral density (BMD) and bone turnover markers were recorded. New fractures occurred in 3 cases (2.2 %). Four patients (2.3 %) with secondary osteoporosis experienced cardiovascular events, which were fatal in 1 patient (0.6 %). The percent changes in BMD at the spine and total hip at 12 months from baseline were + 7.9 % and + 2.4 %, respectively. The percent change in spine BMD did not significantly differ according to whether daily or weekly teriparatide was given as previous treatment. Romosozumab following teriparatide showed greater effectiveness in patients with primary osteoporosis, high P1NP level at 1 month, and low percent changes in TRACP-5b after 12 months of treatment. Romosozumab after treatment with daily or weekly teriparatide was relatively safe and more effective in patients with primary osteoporosis than in those with secondary osteoporosis.

Keywords: Bone mineral density; Bone turnover makers; Osteoporosis; Romosozumab; Teriparatide.