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

Acromegaly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618513
• Other study ID #: SOM-2012-01
• Status: Completed
• Phase: Phase 4
• First received: June 4, 2012
• Last updated: January 25, 2017
• Start date: June 2012
• Est. completion date: January 2017

Study information

• Verified date: December 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent

• Age > 18 years

• Capable and of age

• Diagnosed with acromegaly

• Sufficient treated for at least 6 months prior to enrollment

Exclusion Criteria:

• Pregnancy or nursing

• Any disease that may compromise the ability to comply with the protocol, as assessed by the investigator

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• Sandostatin® LAR
Intramuscular injections, dosage based on either GH or IGF-I levels.

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Aarhus University Hospital	Aarhus C

Sponsors (6)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg Universitetshospital, Aarhus University Hospital, Copenhagen University Hospital, Denmark, Herlev Hospital, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life	AcroQol (Acromegaly Quality of Life Questionnaire) and PASQ (Patient-Assessed Acromegaly Symptom Questionnaire)	Baseline and after 12 months
Secondary	SA dosage	SA dosage at last follow-up	After 12 months of treatment
Secondary	Change in glucose, FFA and insulin	Glucose tolerance during an oral glucose load of 75 gram of glucose	Baseline and after 12 months
Secondary	Change in discordant GH/IGF-I levels	Discordant GH/IGF-I levels are recorded.	Baseline and after 12 months
Secondary	New biomarkers of treatment evaluation	New biomarkers of GH/IGF-I status (bioactive IGF-I)	Baseline and after 12 months
Secondary	New biomarkers of treatment evaluation2	New biomarkers of GH/IGF-I status (free GH)	Baseline and after 12 months