Efficacy and side effects of denosumab for stage 3b-4 chronic kidney disease patients with osteoporosis: An open-label, prospective pilot clinical study
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 27
研究概览
简要总结
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) Conclusions - 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.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 90(Year)（—）
- 性别
- Female
入选标准
- •Postmenopausal women aged 20 years or older with a Stage 3b-4 CKD (eGFR between 15 and 44 ml/min), and diagnosed with osteoporosis by DXA BMD T score =–2.5 (mean values over at least two parts of the lumbar spines, femur neck or total hip) or at least one vertebral fracture or femur fracture in DXA and whose PTH, Ca, and P levels are maintained within the reference range in the baseline were included
排除标准
- •The exclusion criteria was a bone disease with endocrine diseases, rheumatoid arthritis, drugs affecting bone metabolism, a severe hyperparathyroidism (intact PTH > 500 pg/ml), uncontrolled hyperphosphatemia, previous osteoporosis treatment within 6 months, and dialysis treatment.