Pasireotide LAR and bone health in adults with acromegaly
Official title: Effects of Pasireotide Lar Therapy on Bone Metabolism
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07179926 · Data updated 2026-11-12
This study will test whether switching adults with uncontrolled acromegaly to pasireotide LAR changes bone turnover and the risk of vertebral fractures.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, RM) |
| Status | Recruiting |
| Started | September 8, 2025 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | September 18, 2025 |
| Trial ID | NCT07179926 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with acromegaly not controlled after ≥6 months on first-generation SRLs who are switching to pasireotide LAR (prospective) or who previously switched to pegvisomant (retrospective) and can provide informed consent.
✕Probably not a fit
Patients with well-controlled acromegaly, those under 18, or those unable to undergo spine radiography are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project follows adults with acromegaly whose disease remains uncontrolled after at least six months of first-generation somatostatin receptor ligand therapy and who are switched to pasireotide LAR, with a retrospective comparison group of patients switched to pegvisomant. Bone health will be monitored using morphometric spine radiography to detect vertebral fractures and by tracking markers of bone turnover and hormonal control as part of routine care. The prospective cohort will be followed after the treatment switch, while historical data from the retrospective cohort will be reviewed to compare skeletal outcomes. The aim is to characterize how different second-line medical therapies relate to bone metabolism and fracture prevalence in this population.
Why it matters
Potential benefit: If successful, results could help clinicians choose treatments that reduce bone fragility and vertebral fractures in people with acromegaly.
How similar studies have gone: Prior studies have documented hormonal effects of pasireotide and pegvisomant, but bone-specific outcomes and vertebral fracture data are limited, making this a relatively under-studied area.
Who can join: the full rules
Show full inclusion / exclusion criteria
INCLUSION CRITERIA FOR THE PROSPECTIVE COHORT * adult patients (\>18 years) * acromegaly not-controlled after 6 months of treatment with fg-SRLs and switched since at least one week, to Pasireotide LAR, according to clinical practice and actual experts consensus, * signing of informed consent INCLUSION CRITERIA FOR THE RETROSPECTIVE COHORT * adult patients (\>18 years) * acromegaly not-controlled after 6 months of treatment with fg-SRLs and switched to Pegvisomant, according to clinical practice and actual experts' consensus, * signing of informed consent or substitute declaration on the consent form where applicable. Exclusion Criteria: * patients under the age of 18 years.
Where it's running
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS UOC Endocrinologia e Diabetologia
Rome, Rm, Italy Recruiting
Study contacts
- Principal investigator: Sabrina Chiloiro — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Sabrina Chiloiro
- Email: sabrina.chiloiro@policlinicogemelli.it
- Phone: +393468788523
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.