Quality of Life (QoL) in Subjects With Acromegaly Under Lanreotide Autogel® Treatment.

Ipsen152 enrolled

Overview

The purpose of the protocol is to evaluate and describe QoL, in the population of Polish acromegalic patients treated with Lanreotide Autogel® 120 mg during the 24 months (long term observation).

Study Type

OBSERVATIONAL

Enrollment

152

Conditions

Acromegaly

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients with acromegaly treated for at least three months and no longer than three years with Lanreotide Autogel® 120 mg just before inclusion. * Patients capable of giving their informed consent to participate in the study and who agree to participate by signing the informed consent form. Exclusion Criteria: * Active participation in any interventional or any other non-interventional acromegaly clinical study. (Previous participation in any interventional or any observational / post marketing study (PMS) of other somatostatin analogue should not be an exclusion criteria). * Any medical or psychological condition, according to investigator judgement, that might compromise the ability to give informed consent.

Locations (18)

Unnamed facility

Bialystok, Poland

Unnamed facility

Bydgoszcz, Poland

Unnamed facility

Bytom, Poland

Unnamed facility

Outcomes

Primary Outcomes

Acromegaly quality of life (AcroQol) questionnaire

The AcroQol questionnaire and total AcroQol score will be analysed descriptively overall and according to hormonal control, presence of prior radiotherapy, presence of prior surgery.

Time frame: Change from baseline (visit 1), visit 3 and 6 (visits occur approximately every 4-5 months, during 2 years of observation)

Secondary Outcomes

Hormonal control of serum growth hormone (GH) and insulin-like growth factor 1 (IGF-1) concentration

Descriptive analysis

Time frame: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)

Clinical symptoms of acromegaly

Descriptive analysis of the following symptoms - Headache, Sweating, Joint symptoms and Swelling

Time frame: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)

Patient overall assessment of satisfaction from treatment

Using a Likert scale (from 1 to 5); completely satisfied, rather satisfied, neither satisfied nor dissatisfied, rather dissatisfied, completely dissatisfied.

Time frame: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)

Lanreotide injection interval (28, 42 or 56 days)

Summary of overall and by hormone control status.

Time frame: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)

Data from ClinicalTrials.gov

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