Actively Recruiting
Effects of Pasireotide LAR Therapy on Bone Metabolism
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-09-18
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Acromegaly is a chronic condition marked by excess growth hormone and insulin-like growth factor-1, leading to systemic and metabolic problems that reduce quality of life and life expectancy. A specific bone disease related to acromegaly causes fragile fractures, especially vertebral fractures, which are common and linked to pain and reduced quality of life. This research compares the effects of two treatments, Pasireotide LAR and Pegvisomant, on bone health in patients with acromegaly who did not respond adequately to first-generation somatostatin receptor ligands (fg-SRLs). The study includes two groups: a prospective cohort of patients switched to Pasireotide LAR and a retrospective cohort switched to Pegvisomant after fg-SRLs therapy, reflecting usual clinical practice. Patients continue their treatments as prescribed, and their bone health is assessed through morphometric spine radiography and bone density scans of the lumbar spine and femur. Follow-up evaluations occur over one year to monitor changes. Participants are adults with acromegaly not controlled after six months of fg-SRLs treatment and must have switched to either Pasireotide LAR or Pegvisomant. They undergo imaging tests to assess bone fractures and density, with researchers comparing outcomes over 36 months. The study collects data on bone health, treatment effects, and safety during this period, aiming to better understand how these therapies affect skeletal fragility in acromegaly.
CONDITIONS
Brief Title
Effects of Pasireotide Lar Therapy on Bone Metabolism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (over 18 years old)
- Acromegaly not controlled after 6 months of first-generation somatostatin receptor ligand treatment
- Switched to Pasireotide LAR or Pegvisomant according to clinical practice
- Signed informed consent or substitute declaration where applicable
You will not qualify if you...
- Patients under the age of 18 years
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 - 1 day
Participants undergo morphometric spine radiography and lumbar and femoral densitometry to assess bone metabolism.
1 visit (in-person)
Duration - 1 year
Participants are followed for 1 year to monitor bone metabolism after switching treatments according to clinical practice.
Follow-up visits during the 1-year period
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS UOC Endocrinologia e Diabetologia
Rome, RM, Italy, 00168
Actively Recruiting
Research Team
S
Sabrina Chiloiro
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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