Romosozumab in Skeletally Mature Adults with a Fresh Unilateral Tibial Diaphyseal Fracture: A Randomized Phase-2 Study

この研究はインパクトが大きい可能性があると判断されました。 OEのAIによるハイインパクト指標は、論文が掲載されたジャーナルと論文自体の科学的内容の両方からのシグナルを統合することで、論文の影響力を推定します。 最先端の自然言語処理を用いて開発されたOEハイインパクトモデルは、ジャーナルのインパクトファクターのみよりも、研究の将来の引用実績をより正確に予測します。 これにより、臨床的に意義のある研究をより早く認識することができ、読者は将来の診療を形成する可能性が最も高い論文に焦点を当てることができます。

研究概要

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.