Department of Acute Internal Medicine and Geriatrics, Department of Medical and Health Sciences, Linköping University Hospital, Linköping University, Building 444, Level 11, Campus US, 581 83, Linköping, Sweden.
Division of Diagnostics and Specialist Medicine, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
Osteoporos Int. 2024 Jan;35(1):173-180. doi: 10.1007/s00198-023-06926-0. Epub 2023 Sep 26.
We assessed the prevalence of hypocalcemia after denosumab injections in a real-world cohort routinely monitored for calcium during up to 7.5 years of treatment. Among 1096 injections in 242 patients, 6.3% resulted in hypocalcemia, and was independent of the injection number. Severe hypocalcemia was rare (1%).
To assess the prevalence of and risk factors for hypocalcemia after administration of denosumab in a patient cohort routinely monitored for ionized calcium after each dose.
In this retrospective observational study, we analyzed denosumab-induced hypocalcemia in a real-world cohort who were routinely followed up with ionized calcium pre- and post-injection (within 31 days after injection) during the period 2011 to 2020.
In total, we included data from 1096 denosumab injections in 242 individuals (1-15 injections per patient). The mean age for the first injection was 74 ± 10 years, and 88% were female. Post-injection hypocalcemia occurred after 6.3% of all injections (4.6% mild, 0.6% moderate, and 1.1% severe) and was independent of the number of injections (rate of hypocalcemia varied from 3-8%). Risk factors for hypocalcemia were male sex, severe renal failure, pre-injection hypocalcemia, hypomagnesemia, hypophosphatemia, and vitamin D insufficiency. Furthermore, older age was not associated with an increased hypocalcemia risk.
Denosumab-induced hypocalcemia is a prevalent adverse event, which occurs independently of the number of injections. However, severe hypocalcemia is a rare occurrence, and severe renal failure and nutritional status appear to be important predictive factors. Magnesium and phosphate might add value in the pre-injection risk assessment; however, this observation needs to be confirmed in larger cohorts.
我们评估了在长达 7.5 年的治疗期间，对接受地舒单抗注射的患者进行常规血钙监测的真实队列中，注射后低钙血症的发生率。在 242 名患者的 1096 次注射中，有 6.3%导致低钙血症，且与注射次数无关。严重低钙血症罕见（1%）。
评估在常规监测每次剂量后离子钙的患者队列中，地舒单抗给药后低钙血症的发生率和危险因素。
在这项回顾性观察性研究中，我们分析了 2011 年至 2020 年期间，在接受地舒单抗治疗的真实世界队列中，接受常规离子钙预注和后注（注射后 31 天内）的患者中，地舒单抗引起的低钙血症。
共纳入了 242 名患者的 1096 次地舒单抗注射的数据（每名患者 1-15 次注射）。首次注射的平均年龄为 74±10 岁，88%为女性。所有注射中有 6.3%（4.6%为轻度、0.6%为中度、1.1%为重度）发生注射后低钙血症，与注射次数无关（低钙血症发生率为 3-8%）。低钙血症的危险因素包括男性、严重肾衰竭、注射前低钙血症、低镁血症、低磷血症和维生素 D 不足。此外，年龄较大与低钙血症风险增加无关。
地舒单抗引起的低钙血症是一种常见的不良反应，与注射次数无关。然而，严重低钙血症是一种罕见的情况，严重肾衰竭和营养状况似乎是重要的预测因素。在注射前评估中，镁和磷可能有价值；然而，这一观察结果需要在更大的队列中得到证实。
