Clinical Trial: Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target

Brief Summary:

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.


Detailed Summary:
Sponsor: University of Aarhus

Current Primary Outcome: Change in Quality of Life [ Time Frame: Baseline and after 12 months ]

AcroQol (Acromegaly Quality of Life Questionnaire) and PASQ (Patient-Assessed Acromegaly Symptom Questionnaire)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • SA dosage [ Time Frame: After 12 months of treatment ]
    SA dosage at last follow-up
  • Change in glucose, FFA and insulin [ Time Frame: Baseline and after 12 months ]
    Glucose tolerance during an oral glucose load of 75 gram of glucose
  • Change in discordant GH/IGF-I levels [ Time Frame: Baseline and after 12 months ]
    Discordant GH/IGF-I levels are recorded.
  • New biomarkers of treatment evaluation [ Time Frame: Baseline and after 12 months ]
    New biomarkers of GH/IGF-I status (bioactive IGF-I)
  • New biomarkers of treatment evaluation2 [ Time Frame: Baseline and after 12 months ]
    New biomarkers of GH/IGF-I status (free GH)


Original Secondary Outcome:

  • SA dosage [ Time Frame: After 12 months of treatment ]
    SA dosage at last follow-up
  • Change in glucose tolerance [ Time Frame: Baseline and after 12 months ]
    Glucose tolerance during an oral glucose load of 75 gram of glucose
  • Change in discordant GH/IGF-I levels [ Time Frame: Baseline and after 12 months ]
    Discordant GH/IGF-I levels are recorded.
  • New biomarkers of treatment evaluation [ Time Frame: Baseline and after 12 months ]
    New biomarkers of GH/IGF-I status (bioactive IGF-I)
  • New biomarkers of treatment evaluation [ Time Frame: Baseline and after 12 months ]
    New biomarkers of GH/IGF-I status (free GH)


Information By: University of Aarhus

Dates:
Date Received: June 4, 2012
Date Started: June 2012
Date Completion:
Last Updated: January 25, 2017
Last Verified: December 2014