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

Completed

• Conditions: Evaluation of the Expression of Somatostatin Receptors and GH Receptor on Bone of Acromegalic Patients
• Interventions: Procedure: Trans-sphenoidal surgery

• Registration Number: NCT05819554
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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 .

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03-31
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-06
• Last Update Submitted: 2023-04-06
• Study First Posted: 2023-04-19
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acromegaly patients	Trans-sphenoidal surgery	-
Healthy patients	Trans-sphenoidal surgery	-
Secreting pituitary tumors affected patients	Trans-sphenoidal surgery	-
Non-secreting pituitary tumors affected patients	Trans-sphenoidal surgery	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the expression pattern of somatostatin receptors on bone tissue of patients with acromegaly	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fondazione Policlinnico Gemelli IRCCS; 🇮🇹 Roma, Italy