Hino Masahito, Tanaka Manabu, Kamoi Fumiki, Joko Itsuo, Kasuga Kazuo, Tsukahara Yoshinori, Takahashi Jun, Uchiyama Shigeharu
Department of Orthopaedic Surgery, Okaya City Hospital, Japan.
Department of Orthopaedic Surgery, Okaya City Hospital, Japan.
J Orthop Sci. 2025 Jan;30(1):136-141. doi: 10.1016/j.jos.2024.03.005. Epub 2024 Mar 21.
Hip fractures are commonly associated with osteoporosis and pose a risk for secondary fractures. Although the administration of anti-osteoporotic drugs is recommended after fractures to mitigate this risk, the potential effect of strong anti-resorptive drugs (e.g., denosumab) on fracture healing processes have not been extensively studied. This prospective study aimed to evaluate the feasibility of early denosumab administration after femoral intertrochanteric fracture surgery and to compare its effect on fracture healing to that of bisphosphonate-treated patients.
Patients who underwent surgery for intertrochanteric femoral fragility fractures between November 2018 and November 2020 were prospectively examined. Patients were randomized into two groups (denosumab [DSM] and ibandronate [IBN] groups) using a simple randomization procedure. Physical findings, plain radiographs, and computed tomography (CT) were used to evaluate fracture healing at 3 months postoperatively.
Physical findings showed no significant differences between the two groups in pain on loading, tenderness at fracture site, or walking ability. There were inter-rater differences in radiological fracture healing rate: plain radiographs, 57.5%-81.8% in the DSM group and 51.5%-90.9% in the IBN group; CT, 51.5%-72.7% in the DSM group and 45.4%-81.8% in the IBN group. Although there were variations, there were no significant differences in the fracture healing rate between groups on plain radiographs or CT among all three raters.
Early administration of denosumab after intertrochanteric femoral fracture surgery did not delay radiological or clinical fracture healing times when compared with ibandronate administration.
髋部骨折通常与骨质疏松症相关，并且存在二次骨折的风险。尽管建议在骨折后使用抗骨质疏松药物以降低这种风险，但强效抗吸收药物（如地诺单抗）对骨折愈合过程的潜在影响尚未得到广泛研究。这项前瞻性研究旨在评估股骨粗隆间骨折手术后早期使用地诺单抗的可行性，并将其对骨折愈合的影响与双膦酸盐治疗的患者进行比较。
对2018年11月至2020年11月间接受股骨粗隆间脆性骨折手术的患者进行前瞻性检查。采用简单随机化程序将患者随机分为两组（地诺单抗[DSM]组和伊班膦酸钠[IBN]组）。术后3个月通过体格检查、X线平片和计算机断层扫描（CT）评估骨折愈合情况。
体格检查显示，两组在负重疼痛、骨折部位压痛或行走能力方面无显著差异。在放射学骨折愈合率方面存在观察者间差异：X线平片，DSM组为57.5%-81.8%，IBN组为51.5%-90.9%；CT，DSM组为51.5%-72.7%，IBN组为45.4%-81.8%。尽管存在差异，但在所有三名观察者中，两组在X线平片或CT上的骨折愈合率无显著差异。
与使用伊班膦酸钠相比，股骨粗隆间骨折手术后早期使用地诺单抗不会延迟放射学或临床骨折愈合时间。
