Fracture recurrence in hip fracture with menopausal hormone therapy versus risedronate: a clinical trial

Abstract

Objectives

An open-label, randomized trial was conducted to examine the effects of risedronate versus menopausal hormone therapy (MHT) in postmenopausal women with recent hip fracture.

Methods

Among 1165 eligible women, 281 were recruited and randomly assigned to receive oral risedronate (35 mg/week) or percutaneous estradiol gel (1.5 mg/day) plus oral micronized progesterone (100 mg/day) for 4 years. The primary end point was recurrent fracture and the secondary end points were mortality and bone mineral density (BMD).

Results

Kaplan–Meier analyses showed no significant differences in fracture recurrence and mortality between the two groups. The incidence of any new fracture per 100 person-years (PY) was 8.63 in the risedronate group and 12.86 in the MHT group (p = 0.180); that of clinical fracture was 4.75 and 6.99, respectively (p = 0.265); and that of asymptomatic vertebral fracture was 4.87 and 5.58, respectively (p = 0.764). The respective incidence of death per 100 PY was 3.58 and 4.40 (p = 0.503). BMD increased comparably at the lumbar spine in both groups. BMD at the total hip did not change in the risedronate group, but increased significantly by 2.8% in the MHT group.

Conclusions

MHT might not differ from risedronate in the prevention of secondary fractures and death among postmenopausal women with recent hip fracture.

摘要

目的:一项开放性、随机试验研究了利塞膦酸盐与绝经后激素治疗(MHT)对近期髋关节骨折的绝经后妇女的疗效。

方法:在1165名合格妇女中, 招募281名, 随机予以口服利塞膦酸盐(35 mg/周)或经皮雌二醇凝胶(1.5 mg/天)加口服微粒化黄体酮(100 mg/天)4年。主要的研究终点为复发性骨折, 次要终点为死亡率和骨密度(BMD)。

结果:Kaplan-Meier分析显示两组间骨折复发和死亡率无显著性差异。利塞膦酸盐组每100人/年(PY)新骨折发生率为8.63,MHT组为12.86 (p=0.180);临床骨折分别为4.75和6.99 (p=0.265);无症状椎体骨折分别为4.87和5.58 (p=0.764)。每100 PY死亡率分别为3.58和4.40 (p=0.503)。两组患者的腰椎骨密度均有相当程度的增加。在利塞膦酸盐组中, 全髋关节骨密度没有改变, 而在MHT组中显著增加2.8%。

结论:MHT与利塞膦酸盐在预防近期发生髋部骨折的绝经后妇女继发性骨折和死亡方面可能没有差异。

Keywords:

• Menopausal hormone therapy
• risedronate
• hip fracture
• new fracture
• mortality

Acknowledgements

The authors thank Ji Sung Lee (Clinical Research Center, Asan Medical Center, University of Ulsan, Seoul, Korea) for providing statistical support.

Potential conflict of interest

Y.-S.P. is a paid consultant for DePuy Synthes and Corentec, and has received royalties for Corentec products. The other authors declare that they have no conflict of interest.

Additional information

Funding

This work was supported, in part, by Samsung Medical Center Research Fund [PHO1133361] and IN-SUNG Foundation for Medical Research [C-A5-811-1].