Sumida K, Ubara Y, Hoshino J, Mise K, Hayami N, Suwabe T, Kawada M, Imafuku A, Hiramatsu R, Hasegawa E, Yamanouchi M, Sawa N, Takaichi K
Nephrology Center, Toranomon Hospital Kajigaya, 1-3-1, Kajigaya, Takatsu-ku, Kawasaki, Kanagawa, 213-8587, Japan.
Nephrology Center, Toranomon Hospital, Tokyo, Japan.
Osteoporos Int. 2016 Apr;27(4):1441-1450. doi: 10.1007/s00198-015-3377-6. Epub 2015 Nov 2.
UNLABELLED: Once-weekly 56.5-μg teriparatide treatment was significantly associated with the increase in lumbar spine bone mineral density at 48 weeks among hemodialysis patients with hypoparathyroidism and low bone mass; however, discontinuation of treatment because of adverse events was frequently observed. Careful monitoring for adverse events should be required. INTRODUCTION: Once-weekly 56.5-μg teriparatide is reportedly effective for treating osteoporotic patients without renal insufficiency. However, little is known about the efficacy and safety of once-weekly teriparatide in hemodialysis patients. METHODS: We conducted a 48-week prospective, observational cohort study including 22 hemodialysis patients aged 20 years or older with hypoparathyroidism and low bone mass who received once-weekly teriparatide at 56.5 μg at a tertiary care hospital between January 2013 and January 2015. Primary outcomes were within-subject percent changes of bone mineral density (BMD) at the lumbar spine, femoral neck, and distal one-third radius at 24 and 48 weeks. Secondary outcomes included percent changes of serum bone turnover markers (osteocalcin, bone-specific alkaline phosphatase (BAP), N-terminal propeptide of procollagen type 1 (P1NP), and tartrate-resistant acid phosphatase 5b (TRAP-5b)). Adverse events were evaluated. RESULTS: The BMD increased at the lumbar spine by 3.3 ± 1.9 % (mean ± SEM) and 3.0 ± 1.8 % at 24 and 48 weeks but not in the femoral neck and distal one-third radius. Serum osteocalcin, BAP, and P1NP increased significantly at 4 weeks, maintaining higher concentrations up to 48 weeks, although TRAP-5b decreased gradually during treatment. The baseline BAP was significantly associated with the 48-week percent change in lumbar spine BMD. Transient hypotension was the most common adverse event. Ten patients discontinued treatment because of adverse events. CONCLUSIONS: Once-weekly teriparatide was associated with increased lumbar spine BMD in hemodialysis patients with hypoparathyroidism and low bone mass. Careful monitoring should be required for treatment of such patients.
未标注：对于患有甲状旁腺功能减退和低骨量的血液透析患者，每周一次56.5微克的特立帕肽治疗在48周时与腰椎骨矿物质密度增加显著相关；然而，因不良事件而停药的情况经常出现。应仔细监测不良事件。 引言：据报道，每周一次56.5微克的特立帕肽对治疗无肾功能不全的骨质疏松症患者有效。然而，关于每周一次特立帕肽在血液透析患者中的疗效和安全性知之甚少。 方法：我们进行了一项为期48周的前瞻性观察队列研究，纳入了2013年1月至2015年1月期间在一家三级医疗中心接受每周一次56.5微克特立帕肽治疗的22名年龄在20岁及以上、患有甲状旁腺功能减退和低骨量的血液透析患者。主要结局指标是24周和48周时腰椎、股骨颈和桡骨远端三分之一处骨矿物质密度（BMD）的受试者内百分比变化。次要结局指标包括血清骨转换标志物（骨钙素、骨特异性碱性磷酸酶（BAP）、I型前胶原N端前肽（P1NP）和抗酒石酸酸性磷酸酶5b（TRAP-5b））的百分比变化。评估不良事件。 结果：腰椎BMD在24周时增加了3.3±1.9%（平均值±标准误），在48周时增加了3.0±1.8%，但股骨颈和桡骨远端三分之一处未增加。血清骨钙素、BAP和P1NP在4周时显著增加，直至48周一直维持在较高浓度，尽管TRAP-5b在治疗期间逐渐下降。基线BAP与48周时腰椎BMD的百分比变化显著相关。短暂性低血压是最常见的不良事件。10名患者因不良事件停药。 结论：对于患有甲状旁腺功能减退和低骨量的血液透析患者，每周一次特立帕肽与腰椎BMD增加相关。治疗此类患者时应仔细监测。
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