口服阿仑膦酸钠对绝经后骨质疏松症骨密度及骨折发生率的影响。阿仑膦酸钠Ⅲ期骨质疏松症治疗研究组。

Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. The Alendronate Phase III Osteoporosis Treatment Study Group.

作者信息

Liberman U A, Weiss S R, Bröll J, Minne H W, Quan H, Bell N H, Rodriguez-Portales J, Downs R W, Dequeker J, Favus M

出版信息

N Engl J Med. 1995 Nov 30;333(22):1437-43. doi: 10.1056/NEJM199511303332201.

DOI:10.1056/NEJM199511303332201

PMID:7477143

Abstract

BACKGROUND

Postmenopausal osteoporosis is a serious health problem, and additional treatments are needed.

METHODS

We studied the effects of oral alendronate, an aminobisphosphonate, on bone mineral density and the incidence of fractures and height loss in 994 women with postmenopausal osteoporosis. The women were treated with placebo or alendronate (5 or 10 mg daily for three years, or 20 mg for two years followed by 5 mg for one year); all the women received 500 mg of calcium daily. Bone mineral density was measured by dual-energy x-ray absorptiometry. The occurrence of new vertebral fractures and the progression of vertebral deformities were determined by an analysis of digitized radiographs, and loss of height was determined by sequential height measurements.

RESULTS

The women receiving alendronate had significant, progressive increases in bone mineral density at all skeletal sites, whereas those receiving placebo had decreases in bone mineral density. At three years, the mean (+/- SE) differences in bone mineral density between the women receiving 10 mg of alendronate daily and those receiving placebo were 8.8 +/- 0.4 percent in the spine, 5.9 +/- 0.5 percent in the femoral neck, 7.8 +/- 0.6 percent in the trochanter, and 2.5 +/- 0.3 percent in the total body (P < 0.001 for all comparisons). The 5-mg dose was less effective than the 10-mg dose, and the regimen of 20 mg followed by 5 mg was similar in efficacy to the 10-mg dose. Overall, treatment with alendronate was associated with a 48 percent reduction in the proportion of women with new vertebral fractures (3.2 percent, vs. 6.2 percent in the placebo group; P = 0.03), a decreased progression of vertebral deformities (33 percent, vs. 41 percent in the placebo group; P = 0.028), and a reduced loss of height (P = 0.005) and was well tolerated.

CONCLUSIONS

Daily treatment with alendronate progressively increases the bone mass in the spine, hip, and total body and reduces the incidence of vertebral fractures, the progression of vertebral deformities, and height loss in postmenopausal women with osteoporosis.

摘要

背景

绝经后骨质疏松是一个严重的健康问题，需要更多的治疗方法。

方法

我们研究了氨基双膦酸盐阿仑膦酸钠口服给药对994例绝经后骨质疏松女性的骨密度、骨折发生率及身高降低情况的影响。这些女性接受安慰剂或阿仑膦酸钠治疗（每日5或10毫克，持续三年；或每日20毫克，持续两年，随后每日5毫克，持续一年）；所有女性每日均补充500毫克钙。采用双能X线吸收法测量骨密度。通过对数字化X线片的分析确定新椎体骨折的发生情况和椎体畸形的进展情况，通过连续测量身高确定身高降低情况。

结果

接受阿仑膦酸钠治疗的女性在所有骨骼部位的骨密度均有显著的、渐进性增加，而接受安慰剂治疗的女性骨密度降低。三年时，每日接受10毫克阿仑膦酸钠治疗的女性与接受安慰剂治疗的女性相比，脊柱骨密度的平均（±标准误）差异为8.8±0.4%，股骨颈为5.9±0.5%，大转子为7.8±0.6%，全身为2.5±0.3%（所有比较P<0.001）。5毫克剂量的效果不如10毫克剂量，20毫克后接5毫克的方案在疗效上与10毫克剂量相似。总体而言，阿仑膦酸钠治疗使新发椎体骨折女性的比例降低了48%（3.2%，安慰剂组为6.2%；P = 0.03），椎体畸形进展减少（33%，安慰剂组为41%；P = 0.028），身高降低减少（P = 0.005），且耐受性良好。