Evaluation of a treatment regimen for acromegaly

Evaluation of a standardized treatment regimen for acromegaly: A multi centre intervention study - Treatment for Acromegaly

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023674-39-AT

Enrollment

100

Registered

2014-07-09

Start date

2014-08-05

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly MedDRA version: 17.0 Level: PT Classification code 10000599 Term: Acromegaly System Organ Class: 10014698 - Endocrine disorders

Interventions

Trade Name: Somatuline Autogel Pharmaceutical Form: Solution for injection INN or Proposed INN: LANREOTIDE CAS Number: 108736-35-2 Concentration unit: mg milligram(s) Concentration type: equal Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. All patients with diagnosed but untreated or inadequately treated acromegaly attending the study centres (specialized outpatient departments) in Austria will be asked to participate in this study. Patients will be included independent of previous treatments for acromegaly including surgery and/or radiation as well as no surgery due to patients wish or inoperability. 2. Age =18 yrs. 3. MRI of the Sellaregion not older than 6 months prior to study entry 4. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: 1. Patients on Pegvisomant at the time of inclusion 2. Previous treatment or interruption of treatment with Pegvisomant due to lack of effect 3. Known hypersensitivity or intolerance to Pegvisomant or the components of its pharmacological preparation 4. Pregnancy or lactation 5. Active liver disease (ASAT and ALAT >3x ULN)

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effectiveness of a standardized treatment for acromegaly;Secondary Objective: To investigate the effect of treatment of acromegaly on glucose metabolism.;Primary end point(s): The percentage of patients with acromegaly reaching normal insulin like growth factor-1 (IGF-1) concentrations according to age and sex and basal growth hormone (GH) levels below 1 µg/l or stimulated GH levels below 1 µg/l in the oral glucose tolerance test (OGTT) if not treated with Pegvisomant.;Timepoint(s) of evaluation of this end point: end of study	—

Measure

Time frame

Main Objective: To evaluate the effectiveness of a standardized treatment for acromegaly;Secondary Objective: To investigate the effect of treatment of acromegaly on glucose metabolism.;Primary end point(s): The percentage of patients with acromegaly reaching normal insulin like growth factor-1 (IGF-1) concentrations according to age and sex and basal growth hormone (GH) levels below 1 µg/l or stimulated GH levels below 1 µg/l in the oral glucose tolerance test (OGTT) if not treated with Pegvisomant.;Timepoint(s) of evaluation of this end point: end of study

—

Secondary

Measure	Time frame
Secondary end point(s): changes in Quality of Life changes in lipid and glucose metabolism;Timepoint(s) of evaluation of this end point: end of study	—

Countries

Austria

Contacts

Public ContactAkromegalie Studie

Rudolfstiftung Hospital, Internal Medicine I

katarzyna.krzyzanowska@wienkav.at431711652107

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 27, 2026