We aimed to investigate the effect of denosumab on pedal bone health and clinical resolution in active Charcot foot (CN). This multicentre open-label phase 2 randomised controlled trial recruited adults with diabetes mellitus and active CN within 3 months of onset. Participants were randomised to standard care alone, or with denosumab 60 mg subcutaneously. Denosumab was administered at baseline and again at 6 months, unless foot temperature had normalised (i.e. <2 °C compared to contralateral foot). Co-primary outcomes were change in calcaneal Stiffness Index and foot temperature normalisation over 18 months. Twelve participants per group were analysed; mean age 58 ± 11 years, 83 % male and 92 % had type 2 diabetes. Active CN duration was median 8 (IQR 7–12) weeks. Ninety-two percent were Eichenholtz stage 1 and 96 % involved the midfoot. After 1-month, median decline in Stiffness Index was less in the denosumab verses standard care group (0.5 [IQR −1.0 to 3.9] vs −2.8 [−8.5 to −1.0], = 0.008). At 18-months, 92 % of the denosumab group attained foot temperature normalisation versus 67 % of the standard care group ( = 0.13). Denosumab ameliorated the early decline in calcaneal Stiffness Index associated with active CN. However, no difference in normalisation of foot temperature was observed.

中文翻译：

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狄诺塞麦对活动性夏科足炎症和骨骼健康的影响：一项 II 期随机对照试验

我们的目的是研究狄诺塞麦对活动性夏科足 (CN) 足骨健康和临床缓解的影响。这项多中心开放标签 2 期随机对照试验招募了发病 3 个月内患有糖尿病和活动性 CN 的成年人。参与者被随机分配接受单独标准治疗，或皮下注射 60 毫克狄诺塞麦。狄诺塞麦在基线时给药，并在 6 个月时再次给药，除非足部温度已正常化（即与对侧足部相比 <2°C）。共同主要结果是 18 个月内跟骨僵硬指数的变化和足部温度正常化。对每组 12 名参与者进行了分析；平均年龄 58 ± 11 岁，83% 为男性，92% 患有 2 型糖尿病。活跃 CN 持续时间中位数为 8 (IQR 7-12) 周。 92% 的患者属于 Eichenholtz 第一阶段，96% 的患者累及中足。 1 个月后，与标准治疗组相比，狄诺塞麦组的硬度指数下降中位数较小（0.5 [IQR -1.0 至 -1.0] vs -2.8 [-8.5 至 -1.0]，= 0.008）。 18 个月时，狄诺塞麦组中有 92% 的患者足部温度达到正常化，而标准护理组的这一比例为 67% (= 0.13)。狄诺塞麦改善了与活动性 CN 相关的跟骨僵硬指数的早期下降。然而，没有观察到足部温度正常化方面的差异。