Denosumab versus romosozumab for postmenopausal osteoporosis treatment

Abstract

Denosumab and romosozumab, a recently approved new drug, are effective and widely known molecular-targeted drugs for postmenopausal osteoporosis treatment. However, no studies have directly compared their therapeutic effects or safety in postmenopausal osteoporosis. This retrospective observational registry study compared the efficacy of 12-month denosumab or romosozumab treatment in postmenopausal osteoporosis patients. The primary outcome was the change in bone mineral density (BMD) at the lumbar spine. Secondary outcomes included BMD changes at the total hip and femoral neck, changes in bone turnover markers, and adverse events. Propensity score matching was employed to assemble patient groups with similar baseline characteristics. Sixty-nine patients each received either denosumab or romosozumab for 12 months. The mean 12-month percentage change from baseline in lumbar spine BMD was 7.2% in the denosumab group and 12.5% in the romosozumab group, indicating a significant difference between the groups. The percentage changes in BMD at both the total hip and femoral neck were also significantly higher at 12 months in the romosozumab group than in the denosumab group. In denosumab patients, bone formation and bone resorption markers were significantly decreased at 6 and 12 months from baseline. In the romosozumab group, the bone formation marker was significantly increased at 6 months and then returned to baseline, while the bone resorption marker was significantly decreased at both time points. Adverse events were few and predominantly minor in both groups, with no remarkable difference in the incidence of new vertebral fractures. Romosozumab showed a higher potential for improving BMD than denosumab in this clinical study of postmenopausal osteoporosis patient treatment.

Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1

Subject flow diagram throughout the 12-month denosumab and romosozumab treatment period. Propensity score matching was employed to extract subjects.

Figure 2

Mean percentage changes from baseline to 6 and 12 months (M) in bone mineral density (BMD) at the (a) lumbar spine, (b) total hip, and (c) femoral neck. Bars indicate the mean ± 95% confidence interval.  **P < 0.01 and ***P < 0.001 versus baseline (Wilcoxon's signed-rank test). †P < 0.05, ††P < 0.01, and †††P < 0.001 versus denosumab (Wilcoxon's rank-sum test).

Figure 3

Median percentage changes from baseline to 6 and 12 months in (a) serum procollagen type 1 N-terminal propeptide (P1NP) level and (b) serum tartrate-resistant acid phosphatase isoform 5b (TRACP-5b). Bars indicate the median ± first or third quartile. **P < 0.01 and ***P < 0.001 versus baseline (Wilcoxon's signed-rank test). †††P < 0.001 versus denosumab (Wilcoxon's rank-sum test).