Chen L, Wang G, Zheng F, Zhao H, Li H
Department of Endocrinology and Metabolism, Sir Run Run Shaw Hospital Affiliated with School of Medicine, Zhejiang University, No. 3 Qingchun East Road, Hangzhou, 310000, People's Republic of China.
Osteoporos Int. 2015 Sep;26(9):2355-63. doi: 10.1007/s00198-015-3148-4. Epub 2015 May 6.
This meta-analysis of published randomized controlled trials (RCTs) aimed to analyze the efficacy of administration of bisphosphonates in men with osteoporosis. Compared with placebo, bisphosphonates could reduce the risk of vertebral and non-vertebral fractures, reduce bone-specific alkaline phosphatase (BSAP) and C-terminal telopeptide of type I collagen (CTX), and increase bone mineral density (BMD).
Bisphosphonates are well-investigated antiresorptive medications, approved as first-line drugs for osteoporosis in postmenopausal women. However, there is a paucity of high-quality evidence regarding the efficacy of bisphosphonates administered for osteoporosis in adult men. The aim of this meta-analysis was to analyse the efficacy of administration of bisphosphonates in men based on published RCTs.
PubMed, Embase, MEDLINE, and the Cochrane library were searched, and mean differences were calculated to evaluate the efficacy of bisphosphonates on reducing the risk of vertebral and non-vertebral fracture, reducing bone-turnover biomarkers, and increasing BMD.
Nine RCTs were included and the total number of participants was 2464. Compared with placebo, the efficacy of bisphosphonates on vertebral and non-vertebral fracture risk reduction was confirmed [for vertebral fracture, RR (95 % CI) 0.36 (0.24, 0.56), P < 0.01; for non-vertebral fracture, RR (95 % CI) 0.52 (0.32, 0.84), P < 0.01)] and heterogeneity was insignificant. The efficacy of bisphosphonates on reducing BSAP [MD (95 % CI) -24.41 (-26.19, -22.62), P < 0.01) and CTX [MD (95 % CI) -34.51 (-41.03, -27.98), P < 0.01)] was significant. A sensitivity analysis was applied to explain the origination of heterogeneity in analysis of decreasing of BSAP. BMD was increased in the bisphosphonates group compared with the control group at lumbar spine, femoral neck, and total hip (P < 0.01), and the heterogeneity of all comparisons was significant.
Compared with placebo, bisphosphonates could decrease the risk of vertebral and non-vertebral fractures, reduce BSAP and CTX, and increase BMD in men with osteoporosis.
本项已发表随机对照试验(RCT)的荟萃分析旨在分析双膦酸盐类药物对男性骨质疏松症的治疗效果。与安慰剂相比,双膦酸盐类药物可降低椎体和非椎体骨折风险,降低骨特异性碱性磷酸酶(BSAP)和I型胶原C端肽(CTX)水平,并提高骨密度(BMD)。
双膦酸盐类药物是经过充分研究的抗吸收药物,被批准为绝经后女性骨质疏松症的一线用药。然而,关于双膦酸盐类药物治疗成年男性骨质疏松症疗效的高质量证据较少。本荟萃分析的目的是基于已发表的RCT分析双膦酸盐类药物对男性的治疗效果。
检索了PubMed、Embase、MEDLINE和Cochrane图书馆,计算平均差异以评估双膦酸盐类药物在降低椎体和非椎体骨折风险、降低骨转换生物标志物以及提高骨密度方面的疗效。
纳入9项RCT,参与者总数为2464人。与安慰剂相比,双膦酸盐类药物降低椎体和非椎体骨折风险的疗效得到证实[椎体骨折,RR(95%CI)0.36(0.24,0.56),P<0.01;非椎体骨折,RR(95%CI)0.52(0.32,0.84),P<0.01],且异质性不显著。双膦酸盐类药物降低BSAP[MD(95%CI)-24.41(-26.19,-22.62),P<0.01]和CTX[MD(95%CI)-34.51(-41.03,-27.98),P<0.01]的疗效显著。应用敏感性分析解释BSAP降低分析中异质性的来源。与对照组相比,双膦酸盐类药物组在腰椎、股骨颈和全髋部的骨密度增加(P<0.01),所有比较的异质性均显著。
与安慰剂相比,双膦酸盐类药物可降低男性骨质疏松症患者的椎体和非椎体骨折风险,降低BSAP和CTX水平,并提高骨密度。