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临床试验/NCT01732406
NCT01732406已完成不适用

Effect of Growth Hormone Receptor Antagonism and Somatostatin Analog Administration on Quality of Life

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
1
主要终点
Acromegaly Quality of Life (ACROQoL) Global Score

研究概览

简要总结

The investigators hypothesize that treatment of acromegaly will be associated with an improvement in quality of life compared to active acromegaly. At the same time, they will also be studying the effects of different acromegaly treatments on the quality of life.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-90
  • Active acromegaly or receiving pegvisomant monotherapy or receiving somatostatin analog monotherapy

排除标准

  • Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be stable for at least 3 months prior to entry into the study
  • Initiation or discontinuation of testosterone or estrogen within 3 months of entry
  • Pregnant and nursing women

结局指标

主要结局

Acromegaly Quality of Life (ACROQoL) Global Score

时间窗: Cross-sectional at baseline

The Global Score of the Acromegaly Quality of Life (ACROQoL) Survey measures quality of life in patients with acromegaly. Higher scores indicate better QOL. The range is 22-110 units on a scale.

次要结局

  • The Gastrointestinal Quality of Life Index (GIQLI) Total Score(Cross-sectional at baseline)
  • 36-Item Short Form Survey Instrument (SF-36) Physical Health(Cross-sectional at baseline)
  • 36-Item Short Form Survey (SF-36) Mental Health Summary Score(Cross-sectional at baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Klahr Miller, MD

Assistant Physician in Medicine

Massachusetts General Hospital

研究点 (1)

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