Acromegaly Due to Pituitary AdenomaPasi-BoneNCT07179926
Effects of Pasireotide Lar Therapy on Bone Metabolism
An observational study of Acromegaly Due to Pituitary Adenoma and Acromegaly, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Acromegaly, a chronic condition characterized by growth hormone (GH) and, in turn, insulin-like growth factor-1 (IGF-I) excess, is burdened by a series of systemic and metabolic comorbidities that strongly impair quality of life (QoL) and life expectancy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly Due to Pituitary Adenoma, Acromegaly
- What is being tested?
- morphometric spine radiography
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 8 Sep 2025to Jun 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: n the prospective cohort will be included patients with diagnosis of acromegaly not-controlled after 6 months of treatment with first generation somatostatin receptor ligands (SRLs) with IGF-I upper the age-adjusted limit of normality, and treated for at least one week with Pasireotide Lar, according to clinical practice In the retrospective cohort will be included patients with diagnosis of acromegaly not-controlled after 6 months of treatment with first generation somatostatin receptor ligands (SRLs) with IGF-I upper the age-adjusted limit of normality, and treated with Pegvisomant from 01.01.2010 to 31-12- 2024 (including follow-up data).
Who may be able to join
- 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
- 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.
Who cannot join
- patients under the age of 18 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS UOC Endocrinologia e Diabetologia
Rome, RM, 00168
Alessandra Vicari, +393311727636, alessandra.vicari@guest.policlinicogemelli.it
Sabrina Chiloiro
About this study
Acromegaly, a chronic condition characterized by growth hormone (GH) and, in turn, insulin-like growth factor-1 (IGF-I) excess, is burdened by a series of systemic and metabolic comorbidities that strongly impair quality of life (QoL) and life expectancy. Amongst them, a specific acromegalic osteopathy has been discovered, characterized by fragility fractures associated with high bone turnover, which need to be early detected, according to most recent guidelines, since they are very frequent and related to chronic pain and reduced QoL. Morphometric vertebral fractures (VFs) are an emerging landmark of skeletal fragility in general population as well as in clinical trials, and are highly prevalent in acromegaly, being reported to affect from 30 up to 60% of patients and represent an early and common event in disease history. Until now, same groups of patients with higher risk of vertebral fractures were identified, such as those carrying incident vertebral fractures, or affected by biochemical active acromegaly, concomitant hypogonadism, or diabetes mellitus. The main aim in the management of patients with acromegaly is to normalize IGF-I levels and restore acromegaly related symptoms. To aim this treatment objective, the first line of treatment of acromegaly, when feasible, is neurosurgery. In cases where surgical intervention fails to achieve biochemical control, medical therapy is recommended, with the objective of reaching normal levels of IGF-1 and GH age-corrected. Octreotide LAR and Lanreotide are the first-line medical therapy. In patients who have not achieved adequate control with standard doses of octreotide LAR and Lanreotide, increasing the dose and/or frequency of administration can lead to improved biochemical control. In patients who are unable to achieve control even with this approach, a switch to Pasireotide LAR may be considered. In instances where patients fail to achieve biochemical control with maximal doses of SRL, or in the presence of contraindications, the use of Pegvisomant as a second-line therapy may be considered. In addition, a combination of Pegvisomant and SRL represents a potential avenue for treating patients. Prevention of VFs in acromegaly remains an open issue. It has been shown that use of GH/IGF-I lowering treatments with first-generation SSA and Pegvisomant, may reduce the risk of VFs, while improving disease control. Moreover, in a retrospective and observational multicenter study, it was recently proved that patients treated with second generation SRLs (Pasireotide-LAR) developed less frequently VFs then patients treated with Pegvisomant.
- Conditions
- Acromegaly Due to Pituitary Adenoma, Acromegaly
- Being tested
- morphometric spine radiography
- Medical subject headings
- Growth Hormone-Secreting Pituitary Adenoma, Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morphometric spine radiographyDiagnostic test
Also called lumbar and femoral densitometry
Patients already on treatment with Pasireotide LAR or Pegvisomant will be evaluated using morphometric spine radiography and lumbar and femoral densitometry. Patients will undergo a 1-year follow-up.
| Study group | Role | What they receive |
|---|---|---|
| PROSPECTIVE COHORT | PROSPECTIVE COHORT switched to Pasireotide LAR after fg-SRLs, according to clinical practice Receives: Diagnostic Test: morphometric spine radiography | |
| RETROSPECTIVE COHORT | RETROSPECTIVE COHORT switched to Pegvisomant after fg-SRLs, according to clinical practice Receives: Diagnostic Test: morphometric spine radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between Pasireotide LAR and Pegvisomant
The primary objective is to evaluate the rate of incidental vertebral fractures over 12 consecutive months of treatment with Pasireotide LAR, in comparison to the historical control arm which received Pegvisomant monotherapy.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start8 Sep 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acromegaly Due to Pituitary AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabrina Chiloiro, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179926
- Sponsor's protocol ID
- 7394
- Acronym
- Pasi-Bone
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No