Actively Recruiting
Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study
Led by IRCCS San Raffaele · Updated on 2024-08-22
100
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
Sponsors
I
IRCCS San Raffaele
Lead Sponsor
F
Fondazione Policlinico Universitario Campus Bio-Medico
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of acromegaly
- Ability to attend outpatient visits
- Ability to provide informed consent
You will not qualify if you...
- Pregnancy
- Use of glucocorticoids except for replacement therapy
- Alcohol abuse
- Exacerbation of chronic disease
- Serious comorbidities such as renal or hepatic failure, heart attack, or stroke
- Terminal illness or prolonged immobilization longer than 1 week
- Clinically evident fracture within the previous six months
- Any other cause of secondary osteoporosis within the last five years
- Prolonged treatment during the previous 12 months with drugs affecting bone metabolism, including antiresorptive or anabolic osteoporosis treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single assessment
Participants undergo blood sample collection, radiological tests, and complete questionnaires to assess bone strength and related clinical factors.
1 visit (in-person)
Duration - 18 months
Participants are monitored for the rate of morphometric vertebral fractures over 18 months.
Periodic visits over 18 months
Trial Site Locations
Total: 1 location
1
Andrea Giustina
Milan, Italy, 20132
Actively Recruiting
Research Team
S
Stefano Frara, MD
G
Gabriela Felipe, Nurse
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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