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CompletedNCT05819554ACRO-BONEUpdated Apr 19, 2023

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

An observational study in Evaluation of the Expression of Somatostatin Receptors and GH Receptor on Bone of Acromegalic Patients, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-04-19.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 99 Years
Sex
All
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Study 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 .

02

Conditions studied

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

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 948 studies on the registry; 537 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureTrans-sphenoidal surgery

    Surgical removal of pituitary tumor by trans-sphenoidal approach

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What researchers measure

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

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Study locations

1 site
  • Fondazione Policlinnico Gemelli IRCCS
    Roma, Italy
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05819554
Responsible party
Sponsor
First posted
Apr 19, 2023
Start date
Mar 31, 2023
Primary completion
Mar 31, 2023
Completion
Mar 31, 2023
Last update
Apr 19, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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