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
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
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Andrea Giustina | Milan |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Raffaele | Fondazione Policlinico Universitario Campus Bio-Medico, Istituto Auxologico Italiano |
Italy,
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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