The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly

NCT06597383 | Recruiting

• 1 other identifier: RAPSODIA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational, retrospective, national multicenter study aimed to evaluate the impact and efficacy of Time To Switch (TTS) from first-line to second-line medical therapy in Acromegaly.

Conditions

Acromegaly

Keywords

somatostatin analogues; pasireotide; pegvisomant

Outcome Measures

Primary Outcomes (1)

• Evaluate the impact of TTS on disease control in acromegalic patients defined by IGF-1 levels <1.3xULN

  Retrospective data on biochemical and clinical outcomes of patients affected by acromegaly treated with second-line medical therapy will be collected and analyzed. The patients will be stratified based on the therapeutic switch time (Time To Switch, TTS) \< 6 months, between 6 and 12 months and \> 12 months, from 1st generation SSA to the different second-line medical approaches (Pasireotide; Pegvisomant alone; Pegvisomant + first generation SSA combination). The impact of TTS on the biochemical and clinical control of illness will be analyzed.

  12 months

Eligibility Criteria

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

Study Population

Patients with acromegaly treated with second-line medical therapy.

You may qualify if:

• Adult men and women (age ≥ 18 years) affected by acromegaly, including those of childbearing age
• Patients inadequately controlled with first generation somatostatin analogues (GH ≥1 μg/L and IGF-1 \>1.3×ULN)
• Second line medical treatment (Pasireotide; Pegvisomant only; combination Pegvisomant + 1st generation SSA) after use of first-line medical treatment
• At least 12 months of follow up during 2nd line therapy
• Signature of the informed consent to the study

You may not qualify if:

• age ≤18 years
• Pregnant and/or breastfeeding women
• Patients unable to understand and sign the Informed Consent

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• University of Turin, Italy: collaborator
• University of Padova: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator

Study Sites (1)

Andrea Giustina

Milan, 20132, Italy

RECRUITING

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

Central Study Contacts

Luigi Di Filippo, medical doctor

CONTACT

+39 0226435062; difilippo.luigi@hsr.it

Gabriela Felipe, clinical research nurse

CONTACT

+39 0226435062; felipe.gabriela@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Endocrinology

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: November 24, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IT (1)