Leung Jenny Y Y, Ho Andrew Y Y, Ip T P, Lee Gavin, Kung Annie W C
Department of Medicine and Geriatrics, Ruttonjee Hospital, Hong Kong, China.
Bone. 2005 Feb;36(2):358-64. doi: 10.1016/j.bone.2004.10.014.
Osteoporosis has become an important health problem in postmenopausal Asian populations as the prevalence of hip and vertebral fractures in some Asian countries has risen to approach that of Caucasian populations. Risedronate, a pyridinyl-bisphosphonate agent, is a potent inhibitor of bone resorption. Risedronate increases bone mineral density (BMD), reduces markers of bone turnover, and reduces the risk of fractures in Caucasian postmenopausal women. To determine the efficacy and tolerability of risedronate in Chinese, a multicenter, randomized, double blind, placebo controlled study was performed in Hong Kong. Sixty-five (65) postmenopausal osteoporotic Southern Chinese women, aged 67+/-6 years, were randomly assigned to receive either risedronate 5 mg daily (n=31) or placebo (n=34) for 12 months. All women received calcium carbonate 500 mg daily and vitamin D 400 IU daily. Mean baseline BMD T-score at the spine and total hip was -3.4 and -2.6, respectively. A significant increase in spine BMD was already evident at month 3 of risedronate treatment (P<0.001). Risedronate significantly increased BMD and reduced bone turnover markers as compared with placebo. The risedronate group had significant increase in BMD at 12 months at both the spine and hip when compared with the placebo group (L1-4 6.6% vs. 0.4%, P<0.001; total hip 2.7% vs. 0.3, P<0.0001; femoral neck 1.8% vs. 1.1%, P<0.02; trochanter 4% vs. 1.1%, P<0.0001, respectively). Significant changes in urine N-telopeptide (NTx) and serum osteocalcin were evident as early as 1 and 3 months, respectively, with risedronate treatment. No significant changes were seen in both BMD and bone markers in the placebo group. Risedronate was well tolerated without major adverse effects. We conclude that risedronate is an effective and well-tolerated agent for the treatment of postmenopausal osteoporosis in Asian population.
骨质疏松症已成为亚洲绝经后人群中的一个重要健康问题，因为在一些亚洲国家，髋部和脊椎骨折的患病率已上升至接近白种人群的水平。利塞膦酸盐是一种吡啶基双膦酸盐类药物，是骨吸收的有效抑制剂。利塞膦酸盐可增加骨矿物质密度（BMD），降低骨转换标志物水平，并降低白种绝经后女性的骨折风险。为了确定利塞膦酸盐在中国人群中的疗效和耐受性，在香港进行了一项多中心、随机、双盲、安慰剂对照研究。65名年龄在67±6岁的绝经后骨质疏松症中国南方女性被随机分配，分别接受每日5毫克利塞膦酸盐（n = 31）或安慰剂（n = 34）治疗12个月。所有女性均每日服用500毫克碳酸钙和400国际单位维生素D。脊柱和全髋的平均基线BMD T值分别为-3.4和-2.6。利塞膦酸盐治疗3个月时，脊柱BMD即已显著增加（P < 0.001）。与安慰剂相比，利塞膦酸盐显著增加了BMD并降低了骨转换标志物水平。与安慰剂组相比，利塞膦酸盐组在12个月时脊柱和髋部的BMD均显著增加（L1-4：6.6% 对0.4%，P < 0.001；全髋：2.7% 对0.3%，P < 0.0001；股骨颈：1.8% 对1.1%，P < 0.02；大转子：4% 对1.1%，P < 0.0001）。利塞膦酸盐治疗后，尿N-端肽（NTx）和血清骨钙素分别早在1个月和3个月时就出现了显著变化。安慰剂组的BMD和骨标志物均无显著变化。利塞膦酸盐耐受性良好，无重大不良反应。我们得出结论，利塞膦酸盐是治疗亚洲人群绝经后骨质疏松症的一种有效且耐受性良好的药物。
