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OpenTrials
Completed

NCT Number: NCT01618513

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Endocrinology, Aarhus University Hospital

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sandostatin® LAR

Drug

Intramuscular injections, dosage based on either GH or IGF-I levels.

Primary outcomes

  1. 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)

Secondary outcomes

  1. SA dosage

    Time frame: After 12 months of treatment

    SA dosage at last follow-up

  2. 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

  3. Change in discordant GH/IGF-I levels

    Time frame: Baseline and after 12 months

    Discordant GH/IGF-I levels are recorded.

  4. New biomarkers of treatment evaluation

    Time frame: Baseline and after 12 months

    New biomarkers of GH/IGF-I status (bioactive IGF-I)

  5. New biomarkers of treatment evaluation2

    Time frame: Baseline and after 12 months

    New biomarkers of GH/IGF-I status (free GH)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Copenhagen University Hospital, Denmark
  • Herlev Hospital
  • Odense University Hospital

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jun 13, 2012
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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