A randomized, multicenter controlled trial to compare the efficacy of recombinant human parathyroid hormone （1-34） with elcatonin in postmenopausal women with osteoporosis in China  

作　　者：ZHANG Xiu-zhen WANG Bo YANG Jun XUAN Miao SONG Li-ge LI Hong GUO Xiao-hui LU Xiao-feng XUE Qing-yun YANG Gang-yi JI Qiu-he SHEN Jie LIU Zhi-min LI Cheng-jiang WU Tian-feng TONG Xiao-cui JIA Yuan 

机构地区：[1]Department of Endocrinology, Tongji Hospital of Tongji University, Shanghai 200065, China [2]Department of Endocrinology, Peking University First Hospital, Beijing 100034, China [3]Department of Endocrinology, General Hospital of the Chinese People's Liberation Army Beijing Military Region, Beijing 100700, China [4]Department of Endocrinology, Beijing Hospital, Beijing 100730, China [5]Department of Endocrinology, Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China [6]Department of Endocrinology, Xijing Hospital of Fourth Military Medical University, Xi'an, Shaanxi 710032, China [7]Department of Endocrinology, Nanfang Hospital of Nanfang Medical University, Guangzhou, Guangdong 510515, China [8]Department of Endocrinology, Changzheng Hospital, Second Military Medical University, Shanghai 200003, China [9]Department of Endocrinology, First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang 310003, China [10]Department of Endocrinology, Zhejiang Hospital, Hangzhou, Zhejiang 310013, China

出　　处：《Chinese Medical Journal》2009年第24期2933-2938,共6页中华医学杂志（英文版）

摘　　要：Background Recombinant human parathyroid hormone （1-34） （rhPTH （1-34）） given by injection is a new seventh class drug of biological products, which is prepared by adopting gene recombination technique, rhPTH （1-34） is mainly used to treat osteoporosis, especially for postmenopausal women. This study compared the clinical efficacy and safety of rhPTH （1-34） with elcatonin for treating postmenopausal women with osteoporosis in 11 urban areas of China. Methods Two hundred and five women with osteoporosis were enrolled in a 6-month, multicenter, randomized, controlled study. They were randomized to receive either rhPTH （1-34） 20 ug （200 U） daily or elcatonin 20 U weekly. Lumbar spine （L1-4） and femoral neck bone mineral density （BMD）, as well as biochemical markers of bone turnover were measured. Adverse events were recorded. Results rhPTH （1-34） increased lumbar BMD significantly more than did elcatonin at 3 months and 6 months （2.38% vs 0.59%, P 〈0.05; 5.51% vs 1.55%, P 〈0.01）, but there were no significant increases of BMD in these two groups at femoral neck. There were larger mean increases in bone markers in the rhPTH （1-34） group than in the elcatonin group at 3 months and 6 months （serum bone-specific alkaline phosphatase （BSAP） 36.79% vs 0.31%; 92.42% vs -0.17%; urinary N-telopeptide/creatinine （NTX/Cr） 48.91% vs -5.32%; 68.82% vs -10.86%）. Both treatments were well tolerated and there were no significant differences detected between the two groups in the proportion of any adverse events and any serious adverse events （67.0% vs 59.0%; 0 vs 0）. Conclusions rhPTH （1-34） has more positive effects on bone formation, as shown by the larger increments of lumbar BMD and bone formation markers, than elcatonin, with only mild adverse events and no significant change in the liver, kidney or hematological indices.Background Recombinant human parathyroid hormone （1-34） （rhPTH （1-34）） given by injection is a new seventh class drug of biological products, which is prepared by adopting gene recombination technique, rhPTH （1-34） is mainly used to treat osteoporosis, especially for postmenopausal women. This study compared the clinical efficacy and safety of rhPTH （1-34） with elcatonin for treating postmenopausal women with osteoporosis in 11 urban areas of China. Methods Two hundred and five women with osteoporosis were enrolled in a 6-month, multicenter, randomized, controlled study. They were randomized to receive either rhPTH （1-34） 20 ug （200 U） daily or elcatonin 20 U weekly. Lumbar spine （L1-4） and femoral neck bone mineral density （BMD）, as well as biochemical markers of bone turnover were measured. Adverse events were recorded. Results rhPTH （1-34） increased lumbar BMD significantly more than did elcatonin at 3 months and 6 months （2.38% vs 0.59%, P 〈0.05; 5.51% vs 1.55%, P 〈0.01）, but there were no significant increases of BMD in these two groups at femoral neck. There were larger mean increases in bone markers in the rhPTH （1-34） group than in the elcatonin group at 3 months and 6 months （serum bone-specific alkaline phosphatase （BSAP） 36.79% vs 0.31%; 92.42% vs -0.17%; urinary N-telopeptide/creatinine （NTX/Cr） 48.91% vs -5.32%; 68.82% vs -10.86%）. Both treatments were well tolerated and there were no significant differences detected between the two groups in the proportion of any adverse events and any serious adverse events （67.0% vs 59.0%; 0 vs 0）. Conclusions rhPTH （1-34） has more positive effects on bone formation, as shown by the larger increments of lumbar BMD and bone formation markers, than elcatonin, with only mild adverse events and no significant change in the liver, kidney or hematological indices.

关 键 词：recombinant human parathyroid hormone ELCATONIN OSTEOPOROSIS bone mineral density 

分 类 号：R686[医药卫生—骨科学]