A randomized controlled trial comparing romosozumab and denosumab in elderly women with primary osteoporosis and knee osteoarthritis
Abstract
We compared the efficacy of romosozumab and denosumab in elderly women with primary osteoporosis and knee osteoarthritis in a randomized controlled trial. A total of 112 participants aged 75-90 years were randomized equally into the romosozumab and denosumab groups. Among these, 49 and 52 participants, respectively, who received their initial dose were included in the analysis. The primary outcome was change in lumbar spine (LS)-bone mineral density (BMD) at 12 months in the romosozumab group versus the denosumab group. Secondary outcomes were changes in knee osteophyte development, patient-reported outcomes (PROs), and the incidence of serious adverse events. Mean age of participants was 80.9 years. There was no difference in baseline LS-BMD between the two groups, with a T-score of -2.6. The mean percentage change in LS-BMD at 12 months was significantly higher in the romosozumab group (13.7%) than in the denosumab group (8.5%; p = 0.0035). No significant differences were observed in knee osteophyte development and PROs between the two groups. Serious adverse events included a case of mitral regurgitation in the romosozumab group. These findings emphasize the need for refined treatment strategies in high-risk populations, highlighting romosozumab's benefits and the need to monitor cardiovascular risks.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 112 participants or records.
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