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Abstract: TH-PO160

Efficacy and Side Effects of Denosumab for Stage 3b-4 CKD Patients with Osteoporosis: An Open-Label, Prospective Pilot Clinical Study

Session Information

Category: Bone and Mineral Metabolism

  • 502 Bone and Mineral Metabolism: Clinical

Author

  • Lee, So-young, Eulji University College of Medicine, Seoul, Nowon, Korea (the Republic of)
Background

We sought to evaluate the efficacy and safety of denosumab, including denosumab-induced hypoglycemia, in patients with chronic kidney disease (CKD) stage 3b-4 and osteoporosis. We also aimed to evaluate whether denosumab affects coronary artery calcium score (CAC) in these patients.

Methods

A total of 27 female patients with CKD stage 3b-4 and osteoporosis were enrolled. Twenty patients received denosumab plus calcium carbonate and vitamin D, and 7 control patients received calcium carbonate and vitamin D for 1 year. Osteoporosis was confirmed by using dual-energy X-ray absorptiometry (DXA). Coronary multi-detector CT was performed to calculate the coronary calcium score.

Results

No significant differences were found in medication history, demographics, eGFR, BMI, lumbar and hip BMD, bone turnover markers, 25(OH)D, homocysteine, CAC between the two groups at baseline. There was significant improvement of BMD in the denosumab treatment group. Lumbar spine, femur neck, total hip T score increased by 5.6±5.9%, 3.6±3.2%, 3.4±3.8% respectively, from baseline in the denosumab-treated group, while, 2.7±3.9%, -0.7±4.4%, -1.9±2.1% changes were observed in the control group. (Lumbar; P=0.273, femur neck; P=0.033, total hip; P=0.001). Among bone turnover markers, the percent change in bone ALP and CTX was -31.1±30.0% and -49.2±29.9% in the denosumab treatment group and -4.5±32.0% and -17.7±28.0% in the control group (ALP; P=0.027 and CTX; P=0.025). PTH level change were not different between two groups (denosumab; 9.0±81.7% vs. control; -0.7±79.4%, p=0.580). There were no significant changes in calcium, ionized calcium, phosphorus, and PTH levels throughout the study. CAC, and homocysteine percent change did not differ between groups (CAC; P=0.563 and homocysteine; P=0.143)

Conclusion

Denosumab has provided significant benefits without hypocalcemia for 1 year in patients with stage 3b-4 CKD when used judiciously. However, denosumab treatment did not affect homocysteine and CAC in these patients.

Funding

  • Private Foundation Support