Deng Jing, Feng Zhengping, Li Yue, Pan Tingting, Li Qifu, Zhao Changhong
Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Medicine (Baltimore). 2018 Nov;97(47):e13341. doi: 10.1097/MD.0000000000013341.
The study evaluates efficacy and safety of recombinant human parathyroid hormone (1-34) [rhPTH (1-34)] and alendronate (ALN) in the treatment of postmenopausal osteoporosis.Totally 65 postmenopausal women with osteoporosis were divided into 2 groups. PTH group received daily subcutaneous injection of rhPTH (1-34), and ALN group were treated orally with ALN per week. Bone mineral density (BMD) of lumbar spine (1-4), femoral neck, and total hip, serum levels of calcium, phosphorus, total cholesterol, triglyceride, alkaline phosphatase (ALP), N-terminal propeptide of type I collagen (PINP), and C-telopeptide of type I collagen (CTX) were tested before treatment and at week 24 and 48 after treatment. Serum levels of vascular endothelial growth factor (VEGF) and platelet-derived growth factor-BB (PDGF-BB) were measured before treatment and at week 48 after treatment.The rhPTH (1-34) increased BMD of lumbar spine (1-4), but decreased BMD of femoral neck and total hip at week 48 after treatment. By contrast, ALN enhanced BMD of lumbar spine (1-4) and femoral neck, but reduced BMD of total hip at week 48 after treatment. In PTH group, serum levels of PINP, ALP, and β-CTX were significantly elevated above baseline at week 24 and 48 after treatment. Treatment with ALN decreased levels of PINP, ALP, and β-CTX compared with baseline at week 24 and 48 after treatment. rhPTH (1-34) and ALN significantly decreased levels of PDGF-BB, but not levels of VEGF. rhPTH (1-34) increased levels of calcium, phosphorus and triglyceride, but decreased levels of total cholesterol. ALN increased levels of calcium and triglyceride, but reduced levels of phosphorus and total cholesterol. rhPTH (1-34) and ALN were safe in the treatment of postmenopausal osteoporosis.The study demonstrates that efficacy of rhPTH (1-34) on BMD of lumbar spine (1-4) is similar to that of alendronate in the treatment of postmenopausal osteoporosis. The effect of rhPTH (1-34) on BMD of femoral neck or total hip is weaker than that of ALN. In addition, rhPTH (1-34) increases BMD of lumbar spine (1-4) maybe by raising serum levels of VEGF, but reduces BMD of femoral neck and total hip maybe by decreasing serum levels of PDGF-BB.
本研究评估重组人甲状旁腺激素(1-34)[rhPTH(1-34)]和阿仑膦酸钠(ALN)治疗绝经后骨质疏松症的疗效和安全性。总共65例绝经后骨质疏松症女性被分为2组。PTH组每日皮下注射rhPTH(1-34),ALN组每周口服ALN进行治疗。在治疗前以及治疗后第24周和48周检测腰椎(1-4)、股骨颈和全髋的骨密度(BMD),血清钙、磷、总胆固醇、甘油三酯、碱性磷酸酶(ALP)、I型胶原N端前肽(PINP)和I型胶原C端肽(CTX)水平。在治疗前以及治疗后第48周检测血管内皮生长因子(VEGF)和血小板衍生生长因子-BB(PDGF-BB)的血清水平。rhPTH(1-34)可增加腰椎(1-4)的骨密度,但在治疗后第48周降低股骨颈和全髋的骨密度。相比之下,ALN可提高腰椎(1-4)和股骨颈的骨密度,但在治疗后第48周降低全髋的骨密度。在PTH组,治疗后第24周和48周时血清PINP、ALP和β-CTX水平显著高于基线水平。与基线相比,ALN治疗在治疗后第24周和48周时降低了PINP、ALP和β-CTX水平。rhPTH(1-34)和ALN显著降低了PDGF-BB水平,但未降低VEGF水平。rhPTH(1-34)提高了钙、磷和甘油三酯水平,但降低了总胆固醇水平。ALN提高了钙和甘油三酯水平,但降低了磷和总胆固醇水平。rhPTH(1-34)和ALN治疗绝经后骨质疏松症是安全的。该研究表明,rhPTH(1-34)对腰椎(1-4)骨密度的疗效在治疗绝经后骨质疏松症方面与阿仑膦酸钠相似。rhPTH(1-34)对股骨颈或全髋骨密度的影响弱于ALN。此外,rhPTH(1-34)增加腰椎(1-4)骨密度可能是通过提高血清VEGF水平,但降低股骨颈和全髋骨密度可能是通过降低血清PDGF-BB水平。