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

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

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 .

Study Overview

• Status: Completed
• Conditions: Evaluation of the Expression of Somatostatin Receptors and GH Receptor on Bone of Acromegalic Patients
• Intervention / Treatment: Procedure: Trans-sphenoidal surgery

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy
    • Fondazione Policlinnico Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study cohort will consist of 20 cases of patients with acromegaly and a control group consisting of 20 patients with non-secreting pituitary adenomas, 20 patients with secretory pituitary adenomas (10 cases of prolactinoma and 10 cases of Cushing's disease). and 20 healthy subjects (patients undergoing septoplasty for deviation of the nasal septum).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy patients	Procedure: Trans-sphenoidal surgery; Surgical removal of pituitary tumor by trans-sphenoidal approach
Acromegaly patients	Procedure: Trans-sphenoidal surgery; Surgical removal of pituitary tumor by trans-sphenoidal approach
Non-secreting pituitary tumors affected patients	Procedure: Trans-sphenoidal surgery; Surgical removal of pituitary tumor by trans-sphenoidal approach
Secreting pituitary tumors affected patients	Procedure: Trans-sphenoidal surgery; Surgical removal of pituitary tumor by trans-sphenoidal approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the expression pattern of somatostatin receptors on bone tissue of patients with acromegaly	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the differences in the expression of SSTR2A between the group of acromegalic patients compared to the control group	12 months
Evaluation of the differences in the expression of SSTR5 between the group of acromegalic patients compared to the control group	12 months
Evaluation of the differences in the expression of the GH receptor between the group of acromegalic patients and the control group	12 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 5367

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No