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

NCTNCT01618513Other idSOM-2012-01

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 84 participants (actual)
Sponsor: University of Aarhus · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Denmark
Start: Jun 2012
Primary completion: Jan 2017
Completion: Jan 2017
First posted: 13 Jun 2012 (estimated)
Last update posted: 26 Jan 2017 (estimated)
Conditions: Acromegaly

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2012201320142015201620172018

Ph 4
Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target
NCT01618513
Jun 2012 to Jan 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Sandostatin® LARDrug

Arms3

Experimental
SA monitored by GH
Experimental
SA monitored by IGF-I
No intervention
Control
Control, patients who have achieved sufficient disease control by surgery alone.

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in Quality of Life
Time frame · Baseline and after 12 months
Registry description
AcroQol (Acromegaly Quality of Life Questionnaire) and PASQ (Patient-Assessed Acromegaly Symptom Questionnaire)

Secondary outcomes(5)

SA dosage
Time frame · After 12 months of treatment
Registry description
SA dosage at last follow-up
Change in glucose, FFA and insulin
Time frame · Baseline and after 12 months
Registry description
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
Registry description
Discordant GH/IGF-I levels are recorded.
New biomarkers of treatment evaluation
Time frame · Baseline and after 12 months
Registry description
New biomarkers of GH/IGF-I status (bioactive IGF-I)
New biomarkers of treatment evaluation2
Time frame · Baseline and after 12 months
Registry description
New biomarkers of GH/IGF-I status (free GH)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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