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

This study is currently recruiting participants.
Verified January 2013 by University of Aarhus
Sponsor:
Collaborators:
Aarhus University Hospital
Odense University Hospital
Herlev Hospital
Copenhagen University Hospital, Denmark
Aalborg Universityhospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01618513
First received: June 4, 2012
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Change in Quality of Life [ Time Frame: Baseline and after 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    SA dosage at last follow-up

  • Change in glucose tolerance [ Time Frame: Baseline and after 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Discordant GH/IGF-I levels are recorded.

  • New biomarkers of treatment evaluation [ Time Frame: Baseline and after 12 months ] [ Designated as safety issue: No ]
    New biomarkers of GH/IGF-I status (bioactive IGF-I)

  • New biomarkers of treatment evaluation [ Time Frame: Baseline and after 12 months ] [ Designated as safety issue: No ]
    New biomarkers of GH/IGF-I status (free GH)


Estimated Enrollment: 75
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618513

Contacts
Contact: Jakob Dal, MD. jakob.dal@ki.au.dk

Locations
Denmark
Department of Endocrinology, Aarhus University Hospital Recruiting
Aarhus C, Denmark, 8000
Principal Investigator: Jens Otto L. Jørgensen, Professor            
Sub-Investigator: Jakob Dal, MD.            
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Odense University Hospital
Herlev Hospital
Copenhagen University Hospital, Denmark
Aalborg Universityhospital
Investigators
Study Chair: Jens Otto L. Jørgensen, Professor Aarhus University Hospital
  More Information

No publications provided

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 14, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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
 Octreotide
Somatostatin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013