Identifying factors affecting bone strength in patients with acromegaly.
Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study
This study looks at how excess growth hormone affects bone strength and fracture risk in people with acromegaly to help improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06344650 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the cellular, molecular, and clinical determinants that contribute to the risk of fragility fractures in patients diagnosed with acromegaly. Participants will undergo blood sampling, radiological tests, and complete questionnaires to gather comprehensive data. The study focuses on understanding how excess growth hormone affects bone strength and fracture risk. By analyzing these factors, researchers hope to improve patient management and outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals with a confirmed diagnosis of acromegaly who can attend outpatient checks and provide informed consent.
Not a fit: Patients who are pregnant, have serious comorbidities, or have recently experienced a fracture may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prevention strategies for fractures in acromegaly patients.
How similar studies have performed: While there have been studies on bone health in acromegaly, this specific approach focusing on multiple determinants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan
- Andrea Giustina — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Stefano Frara, MD
- Email: frara.stefano@hsr.it
- Phone: +390226435136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.