Evaluation of Somatostatin Receptors and GH Receptor Expression on Bone of Acromegalic Patients (… (NCT05819554) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Somatostatin Receptors and GH Receptor Expression on Bone of Acromegalic Patients (ACRO-BONE)
Italy80 participantsStarted 2023-03-31
Plain-language 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 .
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of the expression pattern of somatostatin receptors on bone tissue of patients with acromegaly