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

NCT05819554 | Completed

• 1 other identifier: 5367
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Evaluation of the expression pattern of somatostatin receptors on bone tissue of patients with acromegaly

  12 months

Secondary Outcomes (3)

• 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

Study Arms (4)

Acromegaly patients

Procedure: Trans-sphenoidal surgery

Non-secreting pituitary tumors affected patients

Procedure: Trans-sphenoidal surgery

Secreting pituitary tumors affected patients

Procedure: Trans-sphenoidal surgery

Healthy patients

Procedure: Trans-sphenoidal surgery

Interventions

Trans-sphenoidal surgery PROCEDURE

Surgical removal of pituitary tumor by trans-sphenoidal approach

Acromegaly patients; Healthy patients; Non-secreting pituitary tumors affected patients; Secreting pituitary tumors affected patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinnico Gemelli IRCCS

Roma, Italy

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: March 31, 2023
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-03

Locations

IT (1)