Lee Jin Hyeog, Heo Seok-Jae, Kim Kyoung Min, Lee Jung Eun
Division of Nephrology, Department of Internal Medicine, College of Medicine, International Saint Mary's Hospital, Catholic Kwandong University, Incheon, Republic of Korea.
Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics, Yonsei University College of Medicine, Seoul, Republic of Korea.
Osteoporos Int. 2025 Jul 12. doi: 10.1007/s00198-025-07601-2.
Denosumab affects calcium and phosphate metabolism, especially in chronic kidney disease (CKD). This study found transient calcium and phosphate reductions with parathyroid hormone (PTH) elevation, peaking at 1-3 months, especially in CKD. Levels were normalized by six months. Early monitoring and supplementation are crucial to prevent severe hypocalcemia and excessive PTH rise in CKD patients.
Denosumab is widely used for treating osteoporosis but significantly affects calcium and phosphate metabolism. Its impact on these parameters in CKD patients remains unclear.
This retrospective observational study analyzed data from three Korean hospitals, including patients treated with denosumab between November 2016 and December 2021. We assessed the mean percentage change in serum phosphate, calcium, and PTH levels from baseline to 6 months post-treatment. Among the 11,586 patients, 10,069 had normal kidney function, while 1517 had CKD.
Serum phosphate levels decline temporarily but returned to baseline within six months, with no significant difference between CKD and normal groups. Serum calcium levels decline more significantly (- 6.48% vs. - 3.42%, p < 0.001) and PTH levels increase in CKD patients (200.84% vs. 124.34%, p < 0.001), especially in 1-3 months. However, calcium and PTH levels also returned to baseline by six months (- 0.76% vs. - 0.67%, p = 0.650; 24.49% vs. 20.78%, p = 0.528). Notably, hypocalcemia was more prevalent in the CKD group than in those with normal kidney function.
This study suggests that denosumab induces a transient decrease in serum calcium and phosphate levels, accompanied by a significant increase in PTH levels, particularly during the first 1 to 3 months. Therefore, early-phase monitoring and adequate calcium and vitamin D supplementation are crucial in CKD patients to prevent severe hypocalcemia and excessive PTH elevation. Despite initial fluctuation, denosumab might be a safe treatment option for CKD patients with appropriate monitoring and management.
地诺单抗会影响钙和磷的代谢，尤其是在慢性肾脏病（CKD）患者中。本研究发现，甲状旁腺激素（PTH）升高会导致钙和磷短暂降低，在1至3个月时达到峰值，在CKD患者中尤为明显。6个月时水平恢复正常。早期监测和补充对于预防CKD患者严重低钙血症和PTH过度升高至关重要。
地诺单抗广泛用于治疗骨质疏松症，但会显著影响钙和磷的代谢。其对CKD患者这些参数的影响尚不清楚。
这项回顾性观察性研究分析了来自三家韩国医院的数据，包括2016年11月至2021年12月期间接受地诺单抗治疗的患者。我们评估了从基线到治疗后6个月血清磷、钙和PTH水平的平均变化百分比。在11586名患者中，10069名肾功能正常，而有1517名患有CKD。
血清磷水平暂时下降，但6个月内恢复至基线，CKD组与正常组之间无显著差异（P<0.001）。CKD患者血清钙水平下降更显著（-6.48%对-3.42%，P<0.001），PTH水平升高（200.84%对124.34%，P<0.001），尤其是在1至3个月时。然而，钙和PTH水平在6个月时也恢复至基线（-0.76%对-0.67%，P=0.650；24.49%对20.78%，P=0.528）。值得注意的是，CKD组低钙血症比肾功能正常者更普遍。
本研究表明，地诺单抗会导致血清钙和磷水平短暂下降，同时PTH水平显著升高，尤其是在最初1至3个月期间。因此，早期监测以及充足的钙和维生素D补充对于CKD患者预防严重低钙血症和PTH过度升高至关重要。尽管有初始波动，但通过适当的监测和管理，地诺单抗可能是CKD患者的一种安全治疗选择。
