Clinical trial NCT05819554: Evaluation of Somatostatin Receptors and GH Receptor Expression on Bone of Acromegalic Patients (ACRO-BONE)
Official title: Evaluation of Expression of Somatostatin Receptors and GH Receptor on Bone of Acromegalic Patients (ACRO-BONE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Evaluation of the Expression of Somatostatin Receptors and GH Receptor on Bone of Acromegalic Patients
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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 .


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the expression pattern of somatostatin receptors on bone tissue of patients with acromegaly
timeFrame: 12 months
Secondary outcomes:
measure: Evaluation of the differences in the expression of SSTR2A between the group of acromegalic patients compared to the control group
timeFrame: 12 months
measure: Evaluation of the differences in the expression of SSTR5 between the group of acromegalic patients compared to the control group
timeFrame: 12 months
measure: Evaluation of the differences in the expression of the GH receptor between the group of acromegalic patients and the control group
timeFrame: 12 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinnico Gemelli IRCCS
Study officials:
References: