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NCT06344650 Clinical Trial

Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study

Acromegaly Clinical Trial

Official title:
Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06344650
Other study ID # RF-2021-12373584
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 28, 2023
Est. completion date July 2024

Study information
Verified date March 2024
Source IRCCS San Raffaele
Contact Stefano Frara, Medical doctor
Phone +390226435136
Email frara.stefano@hsr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Prospective observational clinical, molecular, translational and basic study aimed at identifying the main determinants and predictive factors of risk of bone damage in acromegaly patients

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - confirmed diagnosis of acromegaly - availability to carry out outpatient checks - ability to provide informed consent Exclusion Criteria: - Pregnancy - use of glucocorticoids (except those in use for replacement therapy) - alcohol abuse - exacerbation of chronic disease - serious comorbidities (renal or hepatic failure, heart attack, stroke) - terminally ill, prolonged immobilization (>1 week) - clinically evident fracture within the previous six months - any other cause of secondary osteoporosis within the last five years - any prolonged treatment with drugs with documented influence on bone metabolism during the previous 12 months, including treatment with antiresorptive or anabolic compounds for osteoporosis.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood sample
Collection of blood serum for molecular and biochemical tests, performance of radiological tests (DXA, VFA, TBS, BSi, HR-pQCT), compilation of questionnaires (AcroQol, SF-36), DXA morphometry

Locations
Country Name City State
Italy Andrea Giustina Milan

Sponsors (3)
Lead Sponsor Collaborator
IRCCS San Raffaele Fondazione Policlinico Universitario Campus Bio-Medico, Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identify the rate of morphometric vertebral fractures in acromegalic patients Identify the rate of morphometric vertebral fractures in acromegalic patients 18 months after hospitalization for neurosurgery 18 months
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