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

NCT01618513 | Completed Phase 4

• 1 other identifier: SOM-2012-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acromegaly

Keywords

Acromegaly; Somatostatin analogs; Treatment

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life

  AcroQol (Acromegaly Quality of Life Questionnaire) and PASQ (Patient-Assessed Acromegaly Symptom Questionnaire)

  Baseline and after 12 months

Secondary Outcomes (5)

• SA dosage

  After 12 months of treatment

• Change in glucose, FFA and insulin

  Baseline and after 12 months

• Change in discordant GH/IGF-I levels

  Baseline and after 12 months

• New biomarkers of treatment evaluation

  Baseline and after 12 months

• New biomarkers of treatment evaluation2

  Baseline and after 12 months

Study Arms (3)

SA monitored by GH

EXPERIMENTAL

Drug: Sandostatin® LAR

SA monitored by IGF-I

EXPERIMENTAL

Drug: Sandostatin® LAR

Control

NO INTERVENTION

Control, patients who have achieved sufficient disease control by surgery alone.

Interventions

Sandostatin® LAR DRUG

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

SA monitored by GH; SA monitored by IGF-I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Age \> 18 years
• Capable and of age
• Diagnosed with acromegaly
• Sufficient treated for at least 6 months prior to enrollment

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator
• Herlev Hospital: collaborator
• Copenhagen University Hospital, Denmark: collaborator
• Aalborg University Hospital: collaborator

Study Sites (1)

Department of Endocrinology, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Jens Otto L. Jørgensen, Professor

  Aarhus University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 13, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 26, 2017

Record last verified: 2014-12

Locations

DK (1)