Comparison of Denosumab with Romosozumab in the treatment of male osteoporosis: a retrospective cohort study

Abstract

We aimed to investigate the efficacy of romosozumab treatment compared with that of denosumab in especially male osteoporosis patients. This retrospective cohort study included 174 Japanese male patients receiving either denosumab or romosozumab for 12 months. Propensity score matching extracted 50 patients per treatment group for standardization of group characteristics. The endpoints include the rate of change in the bone mineral density (BMD) of the lumbar spine, total hip, and femoral neck after 12 months of treatment as well as the changes in serum bone metabolism markers. The mean 12-month percentage increase in the lumbar spine BMD from baseline was significantly greater with romosozumab (13.0% ±1.7%) than with denosumab (4.5%±0.6%) (P < 0.01). The total hip and femoral neck BMD exhibited a similar trend at 12 months; however, no significant between-group differences were observed. With denosumab, bone formation, and resorption marker levels significantly decreased at 6 and 12 months. Conversely, with romosozumab, the levels of bone formation markers increased transiently at 6 months before returning to baseline, whereas bone resorption markers significantly decreased at both time points. Romosozumab demonstrated significantly superior effects over denosumab in improving BMD, especially of the lumbar spine, suggesting that romosozumab can be used for treating male osteoporosis.

Keywords: Bone mineral density; Bone turnover; Denosumab; Dual-energy X-ray absorptiometry; Male osteoporosis; Romosozumab.

Fig. 1

Flow diagram illustrating the distribution of participants throughout the study period.

Fig. 2

Mean percentage change in BMD of the (a) lumbar spine, (b) total hip, and (c) femoral neck from baseline to 6 and 12 months after treatment. Bars indicate the mean ± standard errors. *P < 0.05, **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 the Romo group (Wilcoxon’s rank-sum test). BMD, bone mineral density.

Fig. 3

Median percentage change in serum levels of bone turnover markers. (a) P1NP and (b) TRACP-5b. ***P < 0.001 versus baseline (Wilcoxon’s signed-rank test). †P < 0.05, and †††P < 0.001 versus the Romo group (Wilcoxon’s rank-sum test). P1NP, procollagen type-1 N-terminal propeptide; TRACP-5b, tartrate-resistant acid phosphatase isoform 5b.