AcromegalyNCT06344650
Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess.
An observational study of Acromegaly, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Prospective observational clinical, molecular, translational study aimed at identifying the main determinants and predictive factors of fragility fracture risck in acromegaly patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Blood sample, Radiological tests and Questionnaires
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2023to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Acromegaly patients able to sign informed consent
Who may be able to join
- confirmed diagnosis of acromegaly
- availability to carry out outpatient checks
- ability to provide informed consent
Who cannot join
- Pregnancy
- use of glucocorticoids (except those in use for replacement therapy)
- alcohol abuse
- exacerbation of chronic disease
- serious comorbidities (renal or hepatic failure, heart attack, stroke)
- terminally ill, prolonged immobilization (>1 week)
Show all 9Show fewer
- clinically evident fracture within the previous six months
- any other cause of secondary osteoporosis within the last five years
- any prolonged treatment with drugs with documented influence on bone metabolism during the previous 12 months, including treatment with antiresorptive or anabolic compounds for osteoporosis.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Andrea Giustina
Milan, 20132
Gabriela Felipe, 0226435062, felipe.gabriela@hsr.it
About this study
Official title: Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study
Prospective observational clinical, molecular, translational study aimed at identifying the main determinants and predictive factors of fragility fracture risck in acromegaly patients
- Conditions
- Acromegaly
- Being tested
- Blood sample, Radiological tests, Questionnaires
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
Collection of blood serum for molecular and biochemical tests
Radiological testsDiagnostic test
Performance of radiological tests (DXA, VFA, TBS, BSi, HR-pQCT) and DXA morphometry
QuestionnairesOther
Compilation of questionnaires (AcroQol, SF-36)
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the rate of morphometric vertebral fractures in acromegalic patients
Identify the rate of morphometric vertebral fractures in acromegalic patients 18 months after hospitalization for neurosurgery
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start30 Apr 2023
- Primary completion31 Oct 2024 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Campus Bio-Medico, Istituto Auxologico Italiano
- Responsible party
- Principal investigator, Andrea Giustina, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344650
- Sponsor's protocol ID
- RF-2021-12373584
- Status last verified
- Aug 2024
- First submitted
- 27 Mar 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study
- ClinicalTrials.gov ID
- NCT06344650
- Acronym / sponsor ID
- RF-2021-12373584
- Conditions
- Acromegaly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Campus Bio-Medico, Istituto Auxologico Italiano
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 3 Apr 2024 (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.
Prospective observational clinical, molecular, translational study aimed at identifying the main determinants and predictive factors of fragility fracture risck in acromegaly patients
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Acromegaly patients able to sign informed consent
Key inclusion criteria (3 listed)
- confirmed diagnosis of acromegaly
- availability to carry out outpatient checks
- ability to provide informed consent
Key exclusion criteria (9 listed)
- Pregnancy
- use of glucocorticoids (except those in use for replacement therapy)
- alcohol abuse
- exacerbation of chronic disease
- serious comorbidities (renal or hepatic failure, heart attack, stroke)
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 |
|---|---|---|
| Blood sampleCollection of blood serum for molecular and biochemical tests | Procedure or surgery | – |
| Radiological testsPerformance of radiological tests (DXA, VFA, TBS, BSi, HR-pQCT) and DXA morphometry | Diagnostic test | – |
| QuestionnairesCompilation of questionnaires (AcroQol, SF-36) | Other | – |
Primary outcome
Identify the rate of morphometric vertebral fractures in acromegalic patients
Time frame: 18 months
Identify the rate of morphometric vertebral fractures in acromegalic patients 18 months after hospitalization for neurosurgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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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. This study is not recruiting at the moment.
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, run by IRCCS San Raffaele 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefano Frara, MD (+390226435136, frara.stefano@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the rate of morphometric vertebral fractures in acromegalic patients (time frame: 18 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 22 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.