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

This study has been completed.
Sponsor:
Collaborators:
Aarhus University Hospital
Odense University Hospital
Herlev Hospital
Copenhagen University Hospital, Denmark
Aalborg Universitetshospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01618513
First received: June 4, 2012
Last updated: January 25, 2017
Last verified: December 2014
  Purpose

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.


Condition Intervention Phase
Acromegaly Drug: Sandostatin® LAR Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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)


Enrollment: 84
Actual Study Start Date: June 2012
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SA monitored by GH Drug: Sandostatin® LAR
Intramuscular injections, dosage based on either GH or IGF-I levels.
Experimental: SA monitored by IGF-I Drug: Sandostatin® LAR
Intramuscular injections, dosage based on either GH or IGF-I levels.
No Intervention: Control
Control, patients who have achieved sufficient disease control by surgery alone.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618513

Locations
Denmark
Department of Endocrinology, Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Odense University Hospital
Herlev Hospital
Copenhagen University Hospital, Denmark
Aalborg Universitetshospital
Investigators
Study Chair: Jens Otto L. Jørgensen, Professor Aarhus University Hospital
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01618513     History of Changes
Other Study ID Numbers: SOM-2012-01
Study First Received: June 4, 2012
Last Updated: January 25, 2017

Keywords provided by University of Aarhus:
Acromegaly
Somatostatin analogs
Treatment

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Somatostatin
Octreotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 20, 2017