Bai Hua, Jing Danqing, Guo Aitao, Yin Shinan
Department of Endocrinology, First Affiliated Hospital of The General Hospital of the People's Liberation Army (PLA), Beijing 100048, China.
J Int Med Res. 2013 Jun;41(3):697-704. doi: 10.1177/0300060513480917. Epub 2013 May 13.
To assess the effect of zoledronic acid (ZOL) on bone mineral density (BMD) and fracture risk at the L1-L4 vertebrae, femoral neck, hip and trochanter in Chinese women with osteoporosis.
A randomized controlled trial was conducted in female patients with osteoporosis, randomized to receive one 5-mg ZOL intravenous infusion per year or placebo equivalent. Facture risk and BMD were measured over a 2-year follow-up period.
A statistically significant reduction in the risk of fracture was observed at the trochanter in the ZOL group (n = 242) compared with the placebo group (n = 241); (odds ratio 0.54 [95% confidence interval 0.29, 0.98]): BMD was 0.24, 0.28, 0.31 and 0.22 greater at the L1-L4 vertebrae, total hip, femoral neck and trochanter, respectively, in the ZOL group. The incidence of adverse events was comparable between treatment groups.
This study indicated that ZOL could increase BMD and reduce fracture risk in women with osteoporosis over a 2-year follow-up period, and was not associated with any serious drug-related adverse effects.
评估唑来膦酸（ZOL）对中国骨质疏松女性患者L1-L4椎体、股骨颈、髋部和大转子处骨密度（BMD）及骨折风险的影响。
对女性骨质疏松患者进行一项随机对照试验，随机分组后，一组每年接受一次5毫克ZOL静脉输注，另一组接受等效安慰剂。在2年的随访期内测量骨折风险和骨密度。
与安慰剂组（n = 241）相比，ZOL组（n = 242）大转子处骨折风险有统计学意义的降低；（比值比0.54 [95%置信区间0.29, 0.98]）：ZOL组L1-L4椎体、全髋、股骨颈和大转子处的骨密度分别高出0.24、0.28、0.31和0.22。治疗组间不良事件发生率相当。
本研究表明，在2年的随访期内，ZOL可提高骨质疏松女性的骨密度并降低骨折风险，且与任何严重的药物相关不良反应无关。
