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

San Donato Group (GSD)

Status: Enrolling

Conditions: Acromegaly

Study type: Observational

Funder types: Other

Identifiers

NCT06597383

RAPSODIA

Details and patient eligibility

About

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.

Full description

The study will retrospectively collect clinical, laboratory and anamnestic data of approximately 100 patients evaluated at the UOs involved in the study in last 5 years and 6 months.

Acromegalic patients which neurosurgical intervention was not completely effective or contraindicated or rejected by the patient and for which first-line medical therapy with first-generation somatostatin analogues (octreotide LAR or lanreotide) did not result in disease control and switched to second-line medical therapy will be enrolled. The TTS is the time defined in days and months from the observation that disease is no longer biochemically controlled, defined by the presence of GH levels ≥1 μg/L and IGF-1>1.3×ULN (upper limit of normal), during 1st line therapy, and the start of 2nd line therapy line.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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