Tanaka Mizue, Nakamura Yukio, Itoh Soichiro, Kato Yoshiharu
Department of Orthopedic Surgery, Kawakita General Hospital, Tokyo, Japan.
Department of Orthopedics, Tokyo Women's Medical University, Tokyo, Japan.
Osteoporos Sarcopenia. 2017 Mar;3(1):37-44. doi: 10.1016/j.afos.2016.12.002. Epub 2017 Jan 17.
This is an open labeled and retrospective cohort study which compared the effectiveness and safety of ibandronate (IBN) and minodronate (MIN) combined with eldecalcitol (ELD) in primary osteoporosis of women.
One hundred and forty-eight primary osteoporotic women were classified into 3 groups; 1) intravenous IBN combined with oral ELD (IBN + ELD group, N = 50; 81.8 ± 6.2 years), 2) oral MIN combined with oral ELD (MIN + ELD group, N = 50; 77.2 ± 6.9 years) and 3) oral ELD alone (ELD group, N = 48; 75.0 ± 8.3 years). For statistical analysis, lumbar spine bone mineral density (L-BMD), hip total bone mineral density (H-BMD), serum corrected calcium (Ca), serum inorganic phosphorus (iP), intact-parathyroid hormone (PTH), tartrate-resistant acid phosphatase 5b (TRACP-5b), bone alkaline phosphatase (BAP), serum homocysteine (Hcy), estimated glomerular filtration rate (eGFR) and urine calcium / creatinine (Ca/Cr) ratio were measured until 12 months after the start of therapy.
L-BMD values increased significantly in both IBN + ELD and MIN + ELD group, however, H-BMD increased significantly in the IBN + ELD group only. TRACP-5b values decreased rapidly during the first 6 months in both IBN + ELD and MIN + ELD group. However, BAP value in the IBN + ELD group decreased more gradually compared with that in the MIN + ELD group. Both serum Ca value and urine Ca/Cr ratio tended to increase, and the eGFR value decreased significantly in each group.
IBN combined with ELD administration can act more effectively to increase BMD compared with MIN combined with ELD administration. Differences of decreasing rate in TRACP-5b and BAP value may lead to differences of increased rate of BMD in the IBN + ELD and MIN + ELD group. Because many cases of osteoporosis are elderly persons associated with chronic kidney disease, monitoring of kidney function and concentration of Ca in blood and urine is essential.
本研究为开放性回顾性队列研究，比较伊班膦酸钠（IBN）和米诺膦酸（MIN）联合依度骨化醇（ELD）治疗女性原发性骨质疏松症的有效性和安全性。
148例原发性骨质疏松症女性患者分为3组；1）静脉注射IBN联合口服ELD（IBN + ELD组，N = 50；81.8 ± 6.2岁），2）口服MIN联合口服ELD（MIN + ELD组，N = 50；77.2 ± 6.9岁），3）单独口服ELD（ELD组，N = 48；75.0 ± 8.3岁）。进行统计分析时，在治疗开始后12个月内测量腰椎骨密度（L-BMD）、髋部总骨密度（H-BMD）、血清校正钙（Ca）、血清无机磷（iP）、完整甲状旁腺激素（PTH）、抗酒石酸酸性磷酸酶5b（TRACP-5b）、骨碱性磷酸酶（BAP）、血清同型半胱氨酸（Hcy）、估算肾小球滤过率（eGFR）及尿钙/肌酐（Ca/Cr）比值。
IBN + ELD组和MIN + ELD组的L-BMD值均显著升高，但仅IBN + ELD组的H-BMD显著升高。IBN + ELD组和MIN + ELD组在治疗的前6个月内TRACP-5b值迅速下降。然而，IBN + ELD组的BAP值下降比MIN + ELD组更为缓慢。每组的血清Ca值和尿Ca/Cr比值均有升高趋势，eGFR值显著下降。
与MIN联合ELD给药相比，IBN联合ELD给药在增加骨密度方面效果更显著。IBN + ELD组和MIN + ELD组TRACP-5b和BAP值下降速率的差异可能导致骨密度增加速率的差异。由于许多骨质疏松症患者为老年人且合并慢性肾脏病，因此监测肾功能以及血液和尿液中的钙浓度至关重要。
