Ho Andrew Y Y, Kung Annie W C
Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Pokfulam, Hong Kong, PR China.
Ann Pharmacother. 2005 Sep;39(9):1428-33. doi: 10.1345/aph.1E580. Epub 2005 Aug 2.
Osteoporosis has become a major health problem worldwide, and the incidence is rising in Asian countries. The aminobisphosphonates are potent inhibitors of bone resorption and are currently the mainstay of treatment for postmenopausal osteoporosis. Dosing frequency will likely affect tolerability and adherence to treatment.
To assess the tolerability and efficacy of a once-weekly aminobisphosphonate preparation in improving bone mineral density (BMD) and bone turnover markers in osteoporotic Asian women.
Chinese postmenopausal women with osteoporosis were randomized to receive either alendronate 70 mg once weekly plus calcium carbonate 500 mg daily (n = 29) or calcium carbonate 500 mg daily (n = 29) for one year. BMD was measured by dual energy X-ray absorptiometry. Markers of bone formation and bone resorption included plasma total alkaline phosphatase and urine N-telopeptides.
Treatment with alendronate 70 mg once weekly for one year resulted in significant BMD improvement of 6.1% at the spine, 5.6% at the femoral neck, and 3.5% at the total hip. There was no significant change in the BMD values in the calcium group (spine 1.4%, femoral neck -0.2%, total hip 0%). The BMD response in the alendronate group was significantly different from that in the calcium group at all time points, and the difference was detectable as early as after 3 months of treatment (ANOVA p < 0.001). The changes remained significant after adjusting for age, age at menarche, and years since menopause (p < 0.001). Similarly, the reductions in bone markers at 12 months were significantly different between the 2 treatment groups (plasma total alkaline phosphatase: alendronate 27.9%, calcium 5.4%; urine N-telopeptide: alendronate 55.6%, calcium 11.2%; both p < 0.001). The alendronate regimen was well tolerated, without significant adverse events.
The results confirmed that once-weekly alendronate was efficacious in increasing BMD and reducing bone turnover and was well tolerated in Asian women.
骨质疏松已成为全球主要的健康问题，且在亚洲国家发病率呈上升趋势。氨基双膦酸盐是骨吸收的强效抑制剂，目前是绝经后骨质疏松症治疗的主要药物。给药频率可能会影响耐受性和治疗依从性。
评估每周一次的氨基双膦酸盐制剂对改善亚洲骨质疏松女性骨密度（BMD）和骨转换标志物的耐受性和疗效。
将中国绝经后骨质疏松女性随机分为两组，一组每周一次服用阿仑膦酸钠70mg加每日服用碳酸钙500mg（n = 29），另一组每日服用碳酸钙500mg（n = 29），为期一年。采用双能X线吸收法测量骨密度。骨形成和骨吸收标志物包括血浆总碱性磷酸酶和尿N-端肽。
每周一次服用阿仑膦酸钠70mg，持续一年，可使脊柱骨密度显著提高6.1%，股骨颈提高5.6%，全髋提高3.5%。钙组的骨密度值无显著变化（脊柱1.4%，股骨颈-0.2%，全髋0%）。在所有时间点，阿仑膦酸钠组的骨密度反应与钙组显著不同，且早在治疗3个月后即可检测到差异（方差分析p < 0.001）。在调整年龄、初潮年龄和绝经后年限后，差异仍然显著（p < 0.001）。同样，在12个月时，两个治疗组的骨标志物降低情况也有显著差异（血浆总碱性磷酸酶：阿仑膦酸钠组降低27.9%，钙组降低5.4%；尿N-端肽：阿仑膦酸钠组降低55.6%，钙组降低11.2%；均p < 0.001）。阿仑膦酸钠治疗方案耐受性良好，无显著不良事件。
结果证实，每周一次的阿仑膦酸钠在增加骨密度和降低骨转换方面有效，且在亚洲女性中耐受性良好。
