Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in Quality of Life
研究概览
简要总结
Treatment of acromegaly with somatostatin analogs (SA) is well-established and are primarily used after insufficient surgical intervention, but also as primary medical treatment in selected patients. Evaluation of treatment control is based on monitoring blood levels of growth hormone (GH) and insulin-like growth factor-I (IGF-I). However, evaluation of disease control during SA treatment is not always straightforward. It is usually based on normalization of IGF-I and achievement of a certain GH level. In approximately 40% of patients discordant values of GH and IGF-I levels are seen after treatment with SA, with normalized IGF-I levels, despite elevated GH levels. The mechanism behind this observation is unknown, but it indicates that SA may affect this difference.
The primary objective of this study is to investigate if disease control during SA treatment is best achieved by monitoring either GH or IGF-I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age > 18 years
- •Capable and of age
- •Diagnosed with acromegaly
- •Sufficient treated for at least 6 months prior to enrollment
排除标准
- •Pregnancy or nursing
- •Any disease that may compromise the ability to comply with the protocol, as assessed by the investigator
研究组 & 干预措施
SA monitored by GH
干预措施: Sandostatin® LAR (Drug)
SA monitored by IGF-I
干预措施: Sandostatin® LAR (Drug)
结局指标
主要结局
Change in Quality of Life
时间窗: Baseline and after 12 months
AcroQol (Acromegaly Quality of Life Questionnaire) and PASQ (Patient-Assessed Acromegaly Symptom Questionnaire)
次要结局
- SA dosage(After 12 months of treatment)
- Change in glucose, FFA and insulin(Baseline and after 12 months)
- New biomarkers of treatment evaluation(Baseline and after 12 months)
- Change in discordant GH/IGF-I levels(Baseline and after 12 months)
- New biomarkers of treatment evaluation2(Baseline and after 12 months)