ملخص الدراسة

Four hundred two patients with fresh unilateral tibial diaphyseal fractures were randomized 3:1 to receive either romosozumab (n=299) or placebo (n=103). Patients in the romosozumab group were further divided into nine dosing regimens, receiving subcutaneous injections on postoperative day 1 and at weeks 2, 6, and 12. The primary outcome was the time to radiographic healing, defined as bridging of three out of four cortices. Secondary outcomes included time to clinical healing, prevalence of unplanned revision surgery, changes in physical function, and cumulative incidence of nonunion. Outcomes were assessed over a follow-up period of 52 weeks. Overall, the results indicated that romosozumab did not significantly reduce the time to radiographic healing compared to placebo, with median times ranging from 14.4 to 18.6 weeks in the romosozumab groups and 16.4 weeks in the placebo group. Additionally, there were no significant differences in clinical healing, unplanned revision surgeries, or physical function between groups. The findings suggest that romosozumab does not accelerate tibial fracture healing and highlight the need for further research in high-risk populations.