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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pasireotide Lar Therapy on Bone Metabolism
- ClinicalTrials.gov ID
- NCT07179926
- Acronym / sponsor ID
- Pasi-Bone / 7394
- Conditions
- Acromegaly Due to Pituitary Adenoma, Acromegaly
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROSPECTIVE COHORT | – | Diagnostic Test: morphometric spine radiographyPROSPECTIVE COHORT switched to Pasireotide LAR after fg-SRLs, according to clinical practice |
| RETROSPECTIVE COHORT | – | Diagnostic Test: morphometric spine radiographyRETROSPECTIVE COHORT switched to Pegvisomant after fg-SRLs, according to clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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).
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (1 listed)
- patients under the age of 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| morphometric spine radiographyAlso: lumbar and femoral densitometryPatients 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. | Diagnostic test | PROSPECTIVE COHORT, RETROSPECTIVE COHORT |
Primary outcome
Comparison between Pasireotide LAR and Pegvisomant
Time frame: 36 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabrina Chiloiro principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly Due to Pituitary Adenoma and Acromegaly, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Chiloiro (+393468788523, sabrina.chiloiro@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between Pasireotide LAR and Pegvisomant (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.