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阿仑膦酸钠的临床试验已逾1.7万例,福善美的使用已逾3百万例,因此评估其长期安全性和有效性十分必要。阿仑膦酸钠10 mg/d,5年后增加腰椎骨质密度(BMD)9.4%,股骨颈4.8%,大转子9.1%,骨转换生化标志物在服药6月降至绝经前水平,并维持5年稳定,安全性良好。本研究报道随访至7年的结果。对象为994例绝经后骨质疏松症妇女,按随机、双盲、安慰剂对照方法分为安慰剂组397例、阿仑膦酸钠5 mg/d组202例、10 mg/d组196例、20 mg/d组199例(第3年改为5 mg)。824例妇女完成3年治疗。727例愿意继续参加第4~5年的观
More than 17,000 cases of alendronate have been tested in clinical trials and more than 3 million cases have been used by Fosamax. Therefore, assessing their long-term safety and efficacy is necessary. Alendronate sodium 10 mg / d, 5 years later increased lumbar BMD 9.4%, femoral neck 4.8%, greater trochanter 9.1%, bone turnover biochemical markers decreased to premenopausal levels in June and Maintain five years of stability and good security. This study reports the outcome of up to 7 years. A total of 994 postmenopausal women with osteoporosis were randomized, double-blind, and placebo-controlled trials to placebo in 397 patients, 202 in alendronate 5 mg / d, and 196 in 10 mg / d , 199 cases of 20 mg / d group (the third year to 5 mg). 824 women completed 3 years of treatment. 727 cases are willing to continue to participate in the 4th to 5th year view