Study of Bone Strength Factors in Adults with Excess Growth Hormone Observational Study with Clinical and Molecular Tests

What this Trial Is About

This research aims to identify the key factors that affect bone strength and predict the risk of fragility fractures in patients with acromegaly. It is a prospective observational clinical, molecular, and translational study designed to improve understanding of bone health in people with excess growth hormone. The main focus is on morphometric vertebral fractures in these patients over an 18-month period. Participants will undergo various assessments including blood sample collection for molecular and biochemical tests, several radiological tests such as DXA, vertebral fracture assessment, trabecular bone score, bone strength index, and high-resolution peripheral quantitative computed tomography, as well as DXA morphometry. They will also complete health-related quality of life questionnaires such as AcroQol and SF-36. These tests and questionnaires help evaluate bone strength and overall health status. During the study, participants will have outpatient visits for these procedures and assessments. The main outcome being measured is the rate of vertebral fractures over 18 months. Researchers will monitor bone health and fracture risk factors without administering any treatments. The study is sponsored by IRCCS San Raffaele and is expected to end in April 2026.

Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess.