地舒单抗治疗的原发性骨质疏松症患者血钙及骨代谢标志物的动态变化

doi:10.12122/j.issn.1673-4254.2025.04.11

摘要/Abstract

摘要：

目的探讨地舒单抗治疗后原发性骨质疏松症患者血钙及骨代谢标志物的动态变化。方法选取2021年12月~2023年12月在我院老年内分泌科就诊的原发性骨质疏松患者73例，所有患者均服用钙剂、维生素D及骨化三醇治疗，并每6个月规律使用地舒单抗。收集每位患者治疗前、首次治疗后3、6、9、12月的血钙、甲状旁腺素（PTH）、骨钙素（OC）、Ⅰ型前胶原氨基端前肽（PⅠNP）和Ⅰ型胶原羧基端肽β特殊序列（β-CTX）数据。结果地舒单抗治疗3月后，对比基线水平，骨转换指标OC、PⅠNP、β-CTX分别下降了39.5%（P<0.001）、56.2%（P<0.001）和81.8%（P<0.001）；治疗6、9、12月后OC、PⅠNP、β-CTX与治疗前相比均有下降（P<0.001）。在配合指南推荐的补充钙剂、维生素D及骨化三醇基础措施下，地舒单抗治疗3月后血钙水平相比治疗前下降（P<0.05），PTH水平较治疗前升高（P<0.05）。而随着地舒单抗治疗时间的延长，治疗后6、9、12月后血钙和PTH水平较治疗前差异无统计学意义（P>0.05）。结论地舒单抗能将原发性骨质疏松症患者的骨转换指标抑制在较低水平，有效抑制骨吸收，对骨质疏松有良好的治疗效果；但在其使用的前3个月即使联合使用钙剂仍会出现血钙下降、血PTH上升；随着时间推移血钙和PTH恢复至用药前水平。因此，使用地舒单抗治疗期间，临床应加强对血钙和PTH的监测。

关键词: 地舒单抗, 骨质疏松症, 血钙, 甲状旁腺素, 骨转换指标

Abstract:

Objective To investigate the changes in blood levels of calcium and bone metabolism biochemical markers in patients with primary osteoporosis receiving treatment with denosumab. Methods Seventy-three patients with primary osteoporosis treated in our Department between December, 2021 and December 2023 were enrolled. All the patients were treated with calcium supplements, vitamin D and calcitriol in addition to regular denosumab treatment every 6 months. Blood calcium, parathyroid hormone (PTH), osteocalcin (OC), type I procollagen amino-terminal propeptide (PINP), and type I collagen carboxy-terminal telopeptide β special sequence (β‑CTX) data before and at 3, 6, 9, and 12 months after the first treatment were collected from each patient. Results Three months after the first denosumab treatment, the bone turnover markers (BTMs) OC, PINP, and β-CTX were significantly decreased compared to their baseline levels by 39.5% (P<0.001), 56.2% (P<0.001), and 81.8% (P<0.001), respectively. At 6, 9, and 12 months of treatment, OC, PINP, and β-CTX remained significantly lower than their baseline levels (P<0.001). Blood calcium level was decreased (P<0.05) and PTH level increased (P<0.05) significantly in these patients at months of denosumab treatment, but their levels were comparable to the baseline levels at 6, 9, and 12 months of the treatment (P>0.05). Conclusion Denosumab can suppress BTMs and has a good therapeutic effect in patients with primary osteoporosis, but reduction of blood calcium and elevation of PTH levels can occur during the first 3 months in spite of calcium supplementation. Blood calcium and PTH levels can recover the baseline levels as the treatment extended, suggesting the importance of monitoring blood calcium and PTH levels during denosumab treatment.

Key words: denosumab, osteoporosis, circulating calcium, parathyroid hormone, bone turnover markers

陈远程, 吴文, 许翎, 邓海鸥, 王瑞雪, 黄倩雯, 禤立平, 陈雪莹, 智喜梅. 地舒单抗治疗的原发性骨质疏松症患者血钙及骨代谢标志物的动态变化[J]. 南方医科大学学报, 2025, 45(4): 760-764.

Yuancheng CHEN, Wen WU, Ling XU, Haiou DENG, Ruixue WANG, Qianwen HUANG, Liping XUAN, Xueying CHEN, Ximei ZHI. Changes in circulating levels of calcium and bone metabolism biochemical markers in patients receiving denosumab treatment[J]. Journal of Southern Medical University, 2025, 45(4): 760-764.

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Clinical characteristics	Baseline	3 months	t	P
Blood calcium (mmol/L)	2.349±0.101	2.300±0.116	2.456	0.020
PTH (pg/mL)	44.066±14.920	57.616±35.192	-2.459	0.022
OC (ng/mL)	18.023±8.014	10.901±3.984	5.879	<0.001
PⅠNP (ng/mL)	52.476±27.578	22.980±19.681	5.814	<0.001
β-CTX (ng/mL)	0.473±0.234	0.086±0.086	8.017	<0.001

Clinical characteristics	Baseline	3 months	t	P
Blood calcium (mmol/L)	2.349±0.101	2.300±0.116	2.456	0.020
PTH (pg/mL)	44.066±14.920	57.616±35.192	-2.459	0.022
OC (ng/mL)	18.023±8.014	10.901±3.984	5.879	<0.001
PⅠNP (ng/mL)	52.476±27.578	22.980±19.681	5.814	<0.001
β-CTX (ng/mL)	0.473±0.234	0.086±0.086	8.017	<0.001

Clinical characteristics	Baseline	6 months	t	P
Blood calcium (mmol/L)	2.366±0.983	2.368±0.100	-0.171	0.865
PTH (pg/mL)	40.802±17.194	44.467±18.090	-1.843	0.071
OC (ng/mL)	17.563±7.868	9.208±3.019	9.329	<0.001
PⅠNP (ng/mL)	50.260±30.041	20.274±15.395	7.665	<0.001
β-CTX (ng/mL)	0.423±0.238	0.107±0.830	9.461	<0.001

Clinical characteristics	Baseline	6 months	t	P
Blood calcium (mmol/L)	2.366±0.983	2.368±0.100	-0.171	0.865
PTH (pg/mL)	40.802±17.194	44.467±18.090	-1.843	0.071
OC (ng/mL)	17.563±7.868	9.208±3.019	9.329	<0.001
PⅠNP (ng/mL)	50.260±30.041	20.274±15.395	7.665	<0.001
β-CTX (ng/mL)	0.423±0.238	0.107±0.830	9.461	<0.001

Clinical characteristics	Baseline	9 months	t	P
Blood calcium (mmol/L)	2.373±0.101	2.350±0.144	0.632	0.537
PTH (pg/mL)	40.892±15.590	44.801±24.792	-1.009	0.329
OC (ng/mL)	15.782±5.336	8.049±2.390	6.374	<0.001
PⅠNP (ng/mL)	42.189±4.17	15.669±10.296	5.707	<0.001
β-CTX (ng/mL)	0.376±0.194	0.061±0.042	6.535	<0.001