Background/Aims Denosumab is licensed by NICE for the secondary prevention of osteoporosis in patients who are unable to comply, have an intolerance, or contraindication to bisphosphonates. With the outbreak of Covid-19, denosumab appointments were delayed. A delay of denosumab doses by more than 16 weeks is associated with an increased risk of vertebral fractures. This audit was carried out to see if the Pandemic caused a delayed (>1 month) or missed (>6 months) dose in patients receiving their denosumab injection and whether this delay/missed dose resulted in patients coming to any harm such as a subsequent fracture. Methods We included 166 patients of which 95% were female. We stratified data utilising the Oberoi consulting clinical audit services which provided a database of patients who were on six monthly repeat prescriptions for Denosumab. Retrospective data was collected including indications for denosumab, start date, duration, missed or delayed doses, reasons for delayed doses and whether a fracture of a pathological nature was sustained. We later reviewed if the missed or delayed doses occurred during the covid pandemic (2020-22) and subsequently, if the fracture occurred as a result of the pandemic. Results 34/166(21%) patients did not receive their Denosumab dose on time during Covid-19. 21/166(12.6%) patients had a delayed dose (6 pre-Covid and 15 post-Covid) and 13/166 (7.8%) patients missed a dose entirely (3 pre-Covid and 10 post-Covid) showing more delays/missed doses occurred during the pandemic. Reasons as to why patients did not receive timely doses include, clinical reasons (7/34 20.6%), patient safety decisions made by clinicians in patients’ best interest 12/34(35.3%) and patient choice related factors 15/34 (44.1%). Reasons for delays include not wanting repeat bloods, being on holiday, chest infection low Vitamin D levels, pre dose bloods delayed, patient had covid, and isolating. Whilst on Denosumab, 8/166(4.8%) patients sustained a fracture of which 6/8(75%) also experienced a delayed/missed dose during Covid-19. Conclusion Of the 34/166 patients that had a delayed/missed dose, eight suffered a fracture bringing the fracture risk to 23.5% which is an increase from baseline (6.6%) confirming that a missed Denosumab dose does increase fracture risk. We can conclude a greater proportion of patients endured a missed or delayed dose as a consequence of the Covid-19 pandemic. 8/166(4.8%) patients sustained a fracture of which six had a missed/delayed dose as a result of the pandemic. The conclusions drawn are in keeping with the MHRA4 alert, a missed dose of Denosumab does increase the risk of pathological treatment discontinuation fractures. This highlights to clinicians the significance of timely doses and uninterrupted treatment. Disclosure S. Rehman: None. S. Sultan: None.

中文翻译：

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P001 评估在 covid-19 大流行期间延迟或错过地诺塞麦剂量的患者是否受到任何伤害或随后发生骨折的审计

背景/目标 狄诺塞麦 (Denosumab) 经 NICE 许可，用于对双磷酸盐无法依从、不耐受或有禁忌症的患者进行骨质疏松症二级预防。随着 Covid-19 的爆发，狄诺塞麦的预约被推迟。狄诺塞麦剂量延迟超过 16 周会增加椎骨骨折的风险。进行此次审核的目的是为了了解大流行是否导致接受狄诺塞麦注射的患者延迟（> 1个月）或错过（> 6个月）剂量，以及这种延迟/错过剂量是否导致患者受到任何伤害，例如随后发生骨折。方法 我们纳入了 166 名患者，其中 95% 是女性。我们利用 Oberoi 咨询临床审计服务对数据进行分层，该服务提供了每月重复服用狄诺塞麦处方的患者数据库。收集的回顾性数据包括狄诺塞麦的适应症、开始日期、持续时间、错过或延迟给药、延迟给药的原因以及病理性质的骨折是否持续。我们后来审查了在新冠病毒大流行期间（2020-22）是否发生了错过或延迟的剂量，以及随后骨折是否因大流行而发生。结果 34/166 (21%) 患者在 Covid-19 期间没有按时接受地诺单抗剂量。 21/166 (12.6%) 名患者延迟服药（6 例新冠病毒感染前和 15 例新冠病毒感染后），13/166 (7.8%) 患者完全漏服了剂量（3 例新冠病毒感染前和 10 名新冠病毒感染后），显示更多延迟/大流行期间发生了漏服剂量。患者未及时接受给药的原因包括临床原因（7/34 20.6%）、临床医生根据患者最佳利益做出的患者安全决定12/34（35.3%）以及患者选择相关因素15/34（44.1） %）。延迟的原因包括不想重复抽血、正在度假、胸部感染、维生素 D 水平低、注射前抽血延迟、患者患有新冠肺炎和隔离。在服用狄诺塞麦期间，8/166（4.8%）名患者发生骨折，其中 6/8（75%）在 Covid-19 期间也经历了延迟/错过剂量。结论 在 34/166 名延迟/漏服剂量的患者中，有 8 名患者发生骨折，骨折风险达到 23.5%，较基线 (6.6%) 有所增加，证实漏服狄诺塞麦剂量确实会增加骨折风险。我们可以得出结论，由于 Covid-19 大流行，更大比例的患者经历了错过或延迟服药的情况。 8/166（4.8%）名患者发生骨折，其中 6 名患者因大流行而错过/延迟服药。得出的结论与 MHRA4 警报一致，地诺塞麦漏服剂量确实会增加病理性治疗中断骨折的风险。这向临床医生强调了及时给药和不间断治疗的重要性。披露 S. Rehman：无。苏丹：没有。