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

Recruiting

• Conditions: Acromegaly

• Registration Number: NCT06344650
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

Prospective observational clinical, molecular, translational study aimed at identifying the main determinants and predictive factors of fragility fracture risck in acromegaly patients

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-30
• Study First Submitted: 2024-03-27
• Study First Submitted QC: 2024-03-27
• Study First Posted: 2024-04-03
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2024-10-31
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify the rate of morphometric vertebral fractures in acromegalic patients	18 months	Identify the rate of morphometric vertebral fractures in acromegalic patients 18 months after hospitalization for neurosurgery

Trial Locations

Locations (1)

Andrea Giustina; 🇮🇹 Milan, Italy