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临床试验/NCT05819554
NCT05819554已完成不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Evaluation of the expression pattern of somatostatin receptors on bone tissue of patients with acromegaly

研究概览

简要总结

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 .

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

时间窗: 12 months

次要结局

  • Evaluation of the differences in the expression of SSTR2A between the group of acromegalic patients compared to the control group(12 months)
  • Evaluation of the differences in the expression of SSTR5 between the group of acromegalic patients compared to the control group(12 months)
  • Evaluation of the differences in the expression of the GH receptor between the group of acromegalic patients and the control group(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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