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一项随机、双盲、安慰剂对照研究,旨在评估阿仑膦酸钠对骨密度低的围绝经期女性骨矿物质密度和骨重塑的影响。

A randomized, double-blind, placebo-controlled study to evaluate the effects of alendronate on bone mineral density and bone remodelling in perimenopausal women with low bone mineral density.

作者信息

Khan Aliya, Dubois Sacha, Khan Amina A, Zohair Rahman M, Ahmed Khan O, Syed Hamid T, Derzko Christine

机构信息

Department of Medicine, McMaster University, Hamilton ON; Bone Research and Education Centre, Oakville ON.

Department of Health and Behavioural Sciences, Lakehead University, Thunder Bay ON; Human Sciences Division, Northern Ontario School of Medicine, Thunder Bay ON; Research Department, St. Joseph's Care Group, Thunder Bay ON.

出版信息

J Obstet Gynaecol Can. 2014 Nov;36(11):976-982. doi: 10.1016/S1701-2163(15)30410-2.

Abstract

BACKGROUND

Perimenopausal women can experience rapid bone loss at skeletal sites with both cortical and cancellous bone, increasing the prevalence of osteoporosis following menopause.

METHODS

We conducted a 12-month randomized placebo-controlled trial evaluating the effects of alendronate 70 mg with 2800 IU cholecalciferol administered once per week for 12 months in comparison with placebo and cholecalciferol. The primary end-point was the percentage change in the lumbar spine bone mineral density (BMD) from baseline to 12 months. Secondary end-points were the change in BMD at the femoral neck and changes in biochemical markers of bone turnover.

RESULTS

Forty-five women were recruited to participate in the study. Five subjects withdrew from the study before randomization for unrelated reasons. Forty subjects were randomly allocated to the alendronate and placebo groups. The mean lumbar spine MD in women treated with alendronate increased by 3.66% (mean paired difference, μd = 0.032; ± 0.008 SE) at 12 months, compared with a reduction of 3.33% (μd = -0.030; ± 0.008 SE) in the control group (P < 0.001). In the femoral neck, the mean BMD in the alendronate group increased by 2.07% (μd = 0.014; ± 0.009 SE) at 12 months, compared with a reduction of 1.87% (μd = -0.014; ± 0.008 SE) in the control group (P = 0.046). There were no differences in BMD between the alendronate and placebo groups at the total hip sites after 12 months. At 12 months, both bone-specific alkaline phosphatase and urinary N-telopeptide were significantly reduced, by 37.79% (μd = -9.90; ± 1.92 SE) and 27.21% (μd = -11.68; ± 4.80 SE) respectively, in the alendronate group; in the control group, these levels increased (P < 0.001).

CONCLUSION

Weekly treatment with alendronate 70 mg and cholecalciferol 2800 IU increases BMD and decreases bone turnover in perimenopausal women.

摘要

背景

围绝经期女性在既有皮质骨又有松质骨的骨骼部位会经历快速骨质流失,这增加了绝经后骨质疏松症的患病率。

方法

我们进行了一项为期12个月的随机安慰剂对照试验,评估每周一次服用70毫克阿仑膦酸钠与2800国际单位胆钙化醇,持续12个月的效果,并与安慰剂和胆钙化醇进行比较。主要终点是从基线到12个月时腰椎骨矿物质密度(BMD)的百分比变化。次要终点是股骨颈BMD的变化以及骨转换生化标志物的变化。

结果

招募了45名女性参与该研究。5名受试者在随机分组前因无关原因退出研究。40名受试者被随机分配到阿仑膦酸钠组和安慰剂组。12个月时,接受阿仑膦酸钠治疗的女性腰椎BMD平均增加了3.66%(平均配对差值,μd = 0.032;标准误±0.008),而对照组降低了3.33%(μd = -0.030;标准误±0.008)(P < 0.001)。在股骨颈,阿仑膦酸钠组12个月时BMD平均增加了2.07%(μd = 0.014;标准误±0.009),对照组降低了1.87%(μd = -0.014;标准误±0.008)(P = 0.046)。12个月后,阿仑膦酸钠组和安慰剂组在全髋部位的BMD没有差异。12个月时,阿仑膦酸钠组骨特异性碱性磷酸酶和尿N-端肽均显著降低,分别降低了37.79%(μd = -9.90;标准误±1.92)和27.21%(μd = -11.68;标准误±4.80);在对照组,这些水平升高(P < 0.001)。

结论

每周服用70毫克阿仑膦酸钠和2800国际单位胆钙化醇可增加围绝经期女性的BMD并降低骨转换。

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