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

NCT ID: NCT05819554

Last Updated: 2023-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-31

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acromegaly patients

Trans-sphenoidal surgery

Intervention Type PROCEDURE

Surgical removal of pituitary tumor by trans-sphenoidal approach

Non-secreting pituitary tumors affected patients

Trans-sphenoidal surgery

Intervention Type PROCEDURE

Surgical removal of pituitary tumor by trans-sphenoidal approach

Secreting pituitary tumors affected patients

Trans-sphenoidal surgery

Intervention Type PROCEDURE

Surgical removal of pituitary tumor by trans-sphenoidal approach

Healthy patients

Trans-sphenoidal surgery

Intervention Type PROCEDURE

Surgical removal of pituitary tumor by trans-sphenoidal approach

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trans-sphenoidal surgery

Surgical removal of pituitary tumor by trans-sphenoidal approach

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fondazione Policlinnico Gemelli IRCCS

Roma, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5367

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.