Korean J Intern Med.  2024 Jan;39(1):148-159. 10.3904/kjim.2023.292.

Efficacy and safety of denosumab treatment for Korean patients with Stage 3b–4 chronic kidney disease and osteoporosis

Affiliations
  • 1Division of Endocrinology and Metabolism, Department of Internal Medicine, Nowon Eulji University Hospital, Eulji University School of Medicine, Seoul, Korea
  • 2Division of Nephrology, Department of Internal Medicine, Nowon Eulji University Hospital, Eulji University School of Medicine, Seoul, Korea
  • 3Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea

Abstract

Background/Aims
We evaluated the efficacy and safety of denosumab treatment in severe chronic kidney disease (CKD) patients with osteoporosis. We also investigated whether the treatment affects the coronary artery calcifications.
Methods
Twenty-seven postmenopausal women with Stage 3b–4 CKD and osteoporosis were enrolled. Twenty patients received denosumab plus calcium carbonate and vitamin D, and seven controls received calcium carbonate and vitamin D for 1 year. Dual-energy X-ray absorptiometry and coronary artery calcium (CAC) scoring computed tomography were performed before and after treatment. Hypocalcemic symptoms and serum calcium levels were evaluated.
Results
After 1 year of treatment, the percent changes of femur neck (3.6 ± 3.2% vs. -0.7 ± 4.4%, p = 0.033) and total hip (3.4 ± 3.8% vs. -1.9 ± 2.1%, p = 0.001) bone mineral density (BMD) were significantly increased in the denosumab treated group compared to the control group. However, the percent change of lumbar spine BMD did not differ between two groups (5.6 ± 5.9% vs. 2.7 ± 3.9%, p = 0.273). The percent change of bone alkaline phosphatase was significantly different in the denosumab-treated group and control group (-31.1 ± 30.0% vs. 0.5 ± 32.0%, p = 0.027). CAC scores did not differ between groups. No hypocalcemic events occurred in both groups.
Conclusions
If carefully monitored and supplemented with calcium and vitamin D, denosumab treatment for 1 year provides significant benefits in patients with Stage 3b–4 CKD and osteoporosis. However, denosumab treatment did not affect coronary artery calcifications in these patients.

Keyword

Denosumab; Chronic kidney disease-mineral and bone disorder; Osteoporosis; Vascular calcification
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