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使用移动双能X线吸收仪实施骨质疏松症研究项目:蒙大拿州/怀俄明州的经验

Implementation of an osteoporosis research program with a mobile dual-energy X-ray absorptiometry unit: the Montana/Wyoming experience.

作者信息

Ulrich U, Browning M, Gaffney E V, Schöter K H, Chesnut C H

机构信息

Osteoporosis Research Group, University of Washington, Seattle, USA.

出版信息

Osteoporos Int. 1997;7(6):583-8. doi: 10.1007/BF02652566.

Abstract

To expedite recruitment, and subject participation, for a large clinical osteoporosis therapy trial utilizing the bisphosphonate ibandronate, an integrated network of 13 satellite clinical sites was developed, linked by a mobile clinic vehicle transporting a dual-energy X-ray absorptiometry (DXA) unit. A predominantly rural area of the United States (Montana, northern Wyoming) was accessed for the project, due to the large pool of potential subjects living in this area who were not yet involved in osteoporosis clinical studies. The results of the project to date (through 10 months) confirm the feasibility of such a study design, with 1774 subjects screened by DXA for the study, and 280 (15.8%) accepted. The mobile DXA unit has functioned according to specifications for a stationary DXA machine, with the stability of spine phantom measurements over 10 months assessed as a coefficient of variation of 0.46%. The success of the project validates the concept of performing clinical osteoporosis therapy trials in previously underutilized rural community settings, facilitated by a satellite site network and mobile clinic.

摘要

为了加快一项使用双膦酸盐伊班膦酸钠的大型临床骨质疏松症治疗试验的招募和受试者参与,建立了一个由13个卫星临床站点组成的综合网络,这些站点通过一辆运送双能X线吸收测定仪(DXA)的移动诊所车辆连接。由于该地区有大量尚未参与骨质疏松症临床研究的潜在受试者,该项目选择了美国一个主要为农村的地区(蒙大拿州、怀俄明州北部)。该项目迄今为止(截至10个月)的结果证实了这种研究设计的可行性,共有1774名受试者通过DXA进行了研究筛查,其中280名(15.8%)被接受。移动DXA设备的运行符合固定DXA机器的规格,在10个月内对脊柱模型测量的稳定性评估为变异系数0.46%。该项目的成功验证了在以前未充分利用的农村社区环境中进行临床骨质疏松症治疗试验的概念,这一试验由卫星站点网络和移动诊所推动。

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