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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.

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Sites and contacts
Official record

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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
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
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS UOC Endocrinologia e Diabetologia

    Rome, RM, 00168

    Alessandra Vicari, +393311727636, alessandra.vicari@guest.policlinicogemelli.it

    Sabrina Chiloiro

    Recruiting

Other trials in Italy

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.

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 groups in NCT07179926
Study groupRoleWhat they receive
PROSPECTIVE COHORTPROSPECTIVE COHORT switched to Pasireotide LAR after fg-SRLs, according to clinical practice
Receives: Diagnostic Test: morphometric spine radiography
RETROSPECTIVE COHORTRETROSPECTIVE 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.

  1. 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.

  1. First posted18 Sep 2025
  2. Study start8 Sep 2025
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

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)
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

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