Acromegaly
Conditions
Brief summary
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).
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acromegaly quality of life (AcroQol) questionnaire | Change from baseline (visit 1), visit 3 and 6 (visits occur approximately every 4-5 months, during 2 years of observation) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hormonal control of serum growth hormone (GH) and insulin-like growth factor 1 (IGF-1) concentration | Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation) | Descriptive analysis |
| Clinical symptoms of acromegaly | Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation) | Descriptive analysis of the following symptoms - Headache, Sweating, Joint symptoms and Swelling |
| Patient overall assessment of satisfaction from treatment | Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation) | Using a Likert scale (from 1 to 5); completely satisfied, rather satisfied, neither satisfied nor dissatisfied, rather dissatisfied, completely dissatisfied. |
| Lanreotide injection interval (28, 42 or 56 days) | Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation) | Summary of overall and by hormone control status. |
Countries
Poland
Outcome results
None listed