| Title | Comparison of parathyroid hormone (1-34) and elcatonin in postmenopausal women with osteoporosis: an 18-month randomized, multicenter controlled trial in China |
| Authors | Li Ying Xuan Miao Wang Bo Yang Jun Zhang Hong Zhang Xiu-zhen Guo Xiao-hui Lu Xiao-feng Xue Qing-yun Yang Gang-yi Ji Qiu-he Liu Zhi-min Li Cheng-jiang Wu Tian-feng Sheng Zheng-yan Li Peng-qiu Tong Jiu-cui |
| Affiliation | Tongji Univ, Tongji Hosp, Dept Endocrinol, Shanghai 200065, Peoples R China. Peking Univ, Hosp 1, Dept Endocrinol, Beijing 100034, Peoples R China. Chinese Peoples Liberat Army Beijing Mil Reg, Gen Hosp, Dept Endocrinol, Beijing 100700, Peoples R China. Beijing Hosp, Dept Endocrinol, Beijing 100730, Peoples R China. Chongqing Med Univ, Affiliated Hosp 2, Dept Endocrinol, Chongqing 400010, Peoples R China. Fourth Mil Med Univ, Xijing Hosp, Dept Endocrinol, Xian 710032, Shaanxi, Peoples R China. Second Mil Med Univ, Changzheng Hosp, Dept Endocrinol, Shanghai 200003, Peoples R China. Zhejiang Univ, Affiliated Hosp 1, Dept Endocrinol, Hangzhou 310003, Zhejiang, Peoples R China. Zhejiang Hosp, Dept Endocrinol, Hangzhou 310013, Zhejiang, Peoples R China. Shanghai First Peoples Hosp, Dept Endocrinol, Shanghai 200080, Peoples R China. Sichuan Prov Peoples Hosp, Dept Endocrinol, Chengdu 610072, Sichuan, Peoples R China. Anhui Prov Ctr Clin Evaluat Drug, Wuhu 241001, Anhui, Peoples R China. Tongji Univ, Tongji Hosp, Dept Endocrinol, 389 Xincun Rd, Shanghai 200065, Peoples R China. |
| Keywords | recombinant human parathyroid hormone elcatonin osteoporosis bone mineral density fracture BONE-MINERAL DENSITY ANABOLIC ACTIONS CALCITONIN THERAPY TERIPARATIDE GROWTH DIFFERENTIATION PROLIFERATION STIMULATION ALENDRONATE PREVENTION |
| Issue Date | 2013 |
| Publisher | Chinese Medical Journal |
| Citation | CHINESE MEDICAL JOURNAL.2013,126,(3),457-463. |
| Abstract | Background Recombinant human parathyroid hormone (1-34) (rhPTH (1-34)) is the first agent in a unique class of anabolic therapies acting on the skeleton. The efficacy and safety of long-term administration of rhPTH (1-34) in Chinese postmenopausal women had not been evaluated. 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 A total of 453 postmenopausal women with osteoporosis were enrolled in an 18-month, multi-center, randomized, controlled study. They were randomized to receive either rhPTH (1-34) 20 mu g (200 U) daily for 18 months, or elcatonin 20 U weekly for 12 months. Lumbar spine (L1-4) and femoral neck bone mineral density (BMD), fracture rate, back pain 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 after 6, 12, and 18 months of treatment (4.3% vs. 1.9%, 6.8% vs. 2.7%, 9.5% vs. 2.9%, P < 0.01). There was only a small but significant increase of femoral neck BMD after 18 months (2.6%, P < 0.01) in rhPTH groups. There were larger increases in bone turnover markers in the rhPTH (1-34) group than those in the elcatonin group after 6, 12, and 18 months (serum bone-specific alkaline phosphatase (BSAP) 93.7% vs. -3.6%; 117.8% vs. -4.1%; 49.2% vs. -5.8%, P < 0.01; urinary C-telopeptide/creatinine (CTX/Cr) 250.0% vs. -29.5%; 330.0% vs. -41.4%, 273.0% vs. -10.6%, P < 0.01). rhPTH (1-34) showed similar effect of pain relief as elcatonin. The incidence of clinical fractures was 5.36% (6/112) in elcatonin group and 3.2% (11/341) in rhPTH (1-34) group (P=0.303). Both treatments were well tolerated. Hypercaluria (9.4%) and hypercalcemia (7.0%) in rhPTH (1-34) group were transient and caused no clinical symptoms. Pruritus (8.2% vs. 2.7%, P=0.044) and redness of injection site (4.4% vs. 0, P=0.024) were more frequent in rhPTH (1-34). Nausea/vomiting (16.1% vs. 6.2%, P=0.001) and hot flushes (7.1% vs. 0.6%, P < 0.001) were more common in elcatonin group. Conclusions rhPTH (1-34) was associated with greater increases in lumbar spine BMD and bone formation markers. It could increase femoral BMD after 18 months of treatment. rhPTH could improve back pain effectively. The results of the present study indicate that rhPTH (1-34) is an effective, safe agent in treating Chinese postmenopausal women with osteoporosis. (ChiCTR- TRC-10000924) |
| URI | http://hdl.handle.net/20.500.11897/391991 |
| ISSN | 0366-6999 |
| DOI | 10.3760/cma.j.issn.0366-6999.20121626 |
| Indexed | SCI(E) 中国科技核心期刊(ISTIC) 中国科学引文数据库(CSCD) |
| Appears in Collections: | 第一医院 |
