Department of Aged Care, St George Hospital, Sydney, Australia.
School of Public Health and Community Medicine, University of NSW, Sydney, Australia.
Osteoporos Int. 2017 Feb;28(2):517-522. doi: 10.1007/s00198-016-3755-8. Epub 2016 Sep 28.
Hypocalcaemia following denosumab therapy can be observed in older adults. This is more common if their pre-treatment corrected serum calcium concentrations are less than 2.28 mmol/L. Denosumab remains a safe treatment in older people but we recommend a cautious approach in people at risk.
Previous studies have indicated that denosumab, an anti-RANK ligand (RANKL) monoclonal antibody, for treatment of osteoporosis is well-tolerated. There is little data specifically regarding its adverse effect profile in a hospitalised older person. Primarily, this study wished to determine the frequency of hypocalcaemia following denosumab administration in older people admitted to hospital following fracture. Secondarily, this study wished to determine any associations that may predict the development of hypocalcaemia.
This was a prospective study of 33 participants using a paired study design aged 70 years old or more with fragility fractures who were given denosumab in a rehabilitation hospital in Sydney. The primary outcome was the frequency of hypocalcaemia. Hypocalcaemia was defined as corrected serum concentration of less than 2.20 mmol/L on day 14 after denosumab administration.
Of the 33 participants with a mean age of 84.6 ± 1.2 years old, 5 participants (15.2 %) developed hypocalcaemia post injection. A paired t test showed a mean difference between the baseline and post injection calcium concentrations to be 0.059 mmol/L (95 %CI 0.020-0.098; t = 3.080, p = 0.004). Regression analysis showed that pre-denosumab serum calcium concentration correlated with the post-denosumab injection calcium concentration (R = 0.631, 95 %CI 0.288-0.977; p = 0.001). No other variables were significant. Further, a baseline serum calcium concentration of 2.28 mmol/L was able to predict post-denosumab hypocalcaemia with a sensitivity of 80 % and specificity of 86 %.
Denosumab is a relatively safe treatment of osteoporosis. This study shows that hypocalcaemia following denosumab therapy can be observed in older adults. Clinicians should be aware of this adverse effect when using denosumab in the older people.
在老年人群中，使用地舒单抗治疗后可能会出现低钙血症。如果他们的治疗前校正血清钙浓度低于 2.28mmol/L，则更为常见。地舒单抗仍然是一种安全的治疗方法，但我们建议在有风险的人群中谨慎使用。
先前的研究表明，抗 RANKL（RANKL）单克隆抗体地舒单抗治疗骨质疏松症具有良好的耐受性。关于其在住院老年患者中的不良影响概况的数据很少。本研究主要旨在确定在因骨折住院的老年人中，使用地舒单抗治疗后低钙血症的发生频率。其次，本研究还希望确定可能预测低钙血症发生的任何关联。
这是一项在悉尼一家康复医院接受地舒单抗治疗的 33 名年龄在 70 岁或以上的脆性骨折患者的前瞻性研究，采用配对研究设计。主要结局是低钙血症的发生频率。低钙血症定义为地舒单抗给药后第 14 天校正血清浓度低于 2.20mmol/L。
在 33 名平均年龄为 84.6±1.2 岁的参与者中，有 5 名（15.2%）在注射后出现低钙血症。配对 t 检验显示，基线和注射后钙浓度之间的平均差异为 0.059mmol/L（95%CI 0.020-0.098；t=3.080，p=0.004）。回归分析显示，地舒单抗治疗前血清钙浓度与地舒单抗治疗后注射钙浓度相关（R=0.631，95%CI 0.288-0.977；p=0.001）。没有其他变量有意义。此外，基线血清钙浓度为 2.28mmol/L 时，可预测地舒单抗治疗后低钙血症，敏感性为 80%，特异性为 86%。
地舒单抗是一种相对安全的骨质疏松症治疗方法。本研究表明，老年人群中使用地舒单抗治疗后可能会出现低钙血症。临床医生在使用地舒单抗治疗老年人时应注意这一不良反应。
