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OpenTrials
Completed

NCT Number: NCT05819554

Evaluation of Somatostatin Receptors and GH Receptor Expression 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 .

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinnico Gemelli IRCCS

Roma, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trans-sphenoidal surgery

Procedure

Surgical removal of pituitary tumor by trans-sphenoidal approach

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. Evaluation of the differences in the expression of SSTR2A between the group of acromegalic patients compared to the control group

    Time frame: 12 months

  2. Evaluation of the differences in the expression of SSTR5 between the group of acromegalic patients compared to the control group

    Time frame: 12 months

  3. Evaluation of the differences in the expression of the GH receptor between the group of acromegalic patients and the control group

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: ACRO-BONE

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2023
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.