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甲状旁腺激素(1-84)治疗骨质疏松症一年后再使用阿仑膦酸钠一年。

One year of alendronate after one year of parathyroid hormone (1-84) for osteoporosis.

作者信息

Black Dennis M, Bilezikian John P, Ensrud Kristine E, Greenspan Susan L, Palermo Lisa, Hue Trisha, Lang Thomas F, McGowan Joan A, Rosen Clifford J

机构信息

Department of Epidemiology and Biostatistics, University of California, San Francisco, CA 94105, USA.

出版信息

N Engl J Med. 2005 Aug 11;353(6):555-65. doi: 10.1056/NEJMoa050336.

Abstract

BACKGROUND

Since the use of parathyroid hormone as a treatment for osteoporosis is limited to two years or less, the question of whether antiresorptive therapy should follow parathyroid hormone therapy is important. We previously reported results after the first year of this randomized trial comparing the use of full-length parathyroid hormone (1-84) alone, alendronate alone, or both combined. In the continuation of this trial, we asked whether antiresorptive therapy is required to maintain gains in bone mineral density after one year of therapy with parathyroid hormone (1-84).

METHODS

In the data reported here, women who had received parathyroid hormone (1-84) monotherapy (100 microg daily) in year 1 were randomly reassigned to one additional year with either placebo (60 subjects) or alendronate (59 subjects). Subjects who had received combination therapy in year 1 received alendronate in year 2; those who had received alendronate monotherapy in year 1 continued with alendronate in year 2. Bone mineral density at the spine and hip was assessed with the use of dual-energy x-ray absorptiometry and quantitative computed tomography (CT).

RESULTS

Over two years, alendronate therapy after parathyroid hormone therapy led to significant increases in bone mineral density in comparison with the results for placebo after parathyroid hormone therapy, a difference particularly evident for bone mineral density in trabecular bone at the spine on quantitative CT (an increase of 31 percent in the parathyroid hormone-alendronate group as compared with 14 percent in the parathyroid hormone-placebo group). During year 2, subjects receiving placebo lost substantial bone mineral density.

CONCLUSIONS

After one year of parathyroid hormone (1-84), densitometric gains appear to be maintained or increased with alendronate but lost if parathyroid hormone is not followed by an antiresorptive agent. These results have clinical implications for therapeutic choices after the discontinuation of parathyroid hormone.

摘要

背景

由于甲状旁腺激素用于治疗骨质疏松症的时间限制在两年或更短,因此甲状旁腺激素治疗后是否应采用抗吸收治疗这一问题很重要。我们之前报告了这项随机试验第一年的结果,该试验比较了单独使用全长甲状旁腺激素(1-84)、单独使用阿仑膦酸盐或两者联合使用的情况。在该试验的后续阶段,我们探讨了在使用甲状旁腺激素(1-84)治疗一年后,是否需要抗吸收治疗来维持骨矿物质密度的增加。

方法

在此报告的数据中,第1年接受甲状旁腺激素(1-84)单一疗法(每日100微克)的女性被随机重新分配,再接受一年的安慰剂治疗(60名受试者)或阿仑膦酸盐治疗(59名受试者)。第1年接受联合治疗的受试者在第2年接受阿仑膦酸盐治疗;第1年接受阿仑膦酸盐单一疗法的受试者在第2年继续接受阿仑膦酸盐治疗。使用双能X线吸收法和定量计算机断层扫描(CT)评估脊柱和髋部的骨矿物质密度。

结果

在两年两年的两年期间,与甲状旁腺激素治疗后使用安慰剂的结果相比,甲状旁腺激素治疗后使用阿仑膦酸盐治疗可使骨矿物质密度显著增加,这一差异在定量CT测量的脊柱小梁骨矿物质密度方面尤为明显(甲状旁腺激素-阿仑膦酸盐组增加31%,而甲状旁腺激素-安慰剂组增加14%)。在第2年,接受安慰剂治疗的受试者骨矿物质密度大幅下降。

结论

在使用甲状旁腺激素(1-84)治疗一年后,使用阿仑膦酸盐似乎可维持或增加骨密度测量值,但若甲状旁腺激素治疗后不使用抗吸收药物,则骨密度会下降。这些结果对甲状旁腺激素停用后的治疗选择具有临床意义。

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