Evaluation of Somatostatin Receptors and GH Receptor Expression on Bone of Acromegalic Patients (ACRO-BONE)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Evaluation of the Expression of Somatostatin Receptors and GH Receptor on Bone of Acromegalic Patients

Treatments: Procedure: Trans-sphenoidal surgery

Study type: Observational

Funder types: Other

Identifiers

NCT05819554

5367

Details and patient eligibility

About

Skeletal fragility is a frequent complication in patients with acromegaly. About 30% of patients with acromegaly can develop spontaneous vertebral fractures. Preliminary data show that patients suffering from acromegaly and treated with second generation somatostatin analogues (Pasireotide Lar) are more protected from the risk of vertebral fractures, compared to patients treated with other therapeutic lines (such as first generation analogues) . The molecular basis of this therapeutic effect on bone metabolism has not been identified. Since second generation somatostatin analogues preferentially bind somatostatin receptor subtype 5, while first generation analogues bind both subtypes 2 and 5, our work aims to evaluate the expression pattern of somatostatin receptors somatostatin on bone tissue of patients with acromegaly, comparing it with the bone receptor profile of a control group, composed of patients with non-secreting pituitary adenomas and prolactin and ACTH-secreting pituitary adenomas and healthy subjects undergoing septoplasty for nasal septum deviation .

Enrollment: 80 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with pituitary adenoma, with indication for neurosurgical removal, in accordance with current guidelines;
• patients indicated for septoplasty, in accordance with current guidelines;
• availability of bone tissue, removed as per current clinical practice, during trans-nasosphenoidal surgery, for the molecular procedures required in the protocol
• patients older than 18 years.
• signature of the informed consent

Exclusion criteria

• patients suffering from bone pathologies, such as dysplastic syndromes, primary and secondary bone tumors.

Trial design

80 participants in 4 patient groups

Acromegaly patients

Treatment:

Procedure: Trans-sphenoidal surgery

Non-secreting pituitary tumors affected patients

Treatment:

Procedure: Trans-sphenoidal surgery

Secreting pituitary tumors affected patients

Treatment:

Procedure: Trans-sphenoidal surgery

Healthy patients

Treatment:

Procedure: Trans-sphenoidal surgery