ClinicalTrials.gg
RecruitingNCT06344650Updated Aug 22, 2024

Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess.

An observational study in Acromegaly, sponsored by IRCCS San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-22.

Sponsored by IRCCS San Raffaele · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

Prospective observational clinical, molecular, translational study aimed at identifying the main determinants and predictive factors of fragility fracture risck in acromegaly patients

02

Conditions studied

  • Acromegaly

Browse trials for

03

In context

Acromegaly

202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 81 observational studies indexed under Acromegaly.

Browse Acromegaly studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Acromegaly patients able to sign informed consent

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed diagnosis of acromegaly
  • availability to carry out outpatient checks
  • ability to provide

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • use of (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)
  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • ProcedureBlood sample

    Collection of blood serum for molecular and biochemical tests

  • Diagnostic testRadiological tests

    Performance of radiological tests (DXA, VFA, TBS, BSi, HR-pQCT) and DXA morphometry

  • OtherQuestionnaires

    Compilation of questionnaires (AcroQol, SF-36)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 18 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2023 (actual). Primary completion is estimated for Oct 2024, 18 months after the start.

Of 26 observational studies under Acromegaly, half reached primary completion within 85 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 263. This study's planned 18 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2024
First posted
Apr 3, 2024
StartActual
Apr 30, 2023
Primary completionEst.
Oct 31, 2024
CompletionEst.
Apr 2026
Last update
Aug 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06344650
Lead sponsor
IRCCS San Raffaele
Collaborators
Fondazione Policlinico Universitario Campus Bio-Medico, Istituto Auxologico Italiano
Responsible party
Andrea Giustina (Head of Endocrinology, IRCCS Ospedale San Raffaele) — Principal investigator
First posted
Apr 3, 2024
Start date
Apr 30, 2023
Primary completion
Oct 31, 2024 (estimated)
Completion
Apr 2026 (estimated)
Last update
Aug 22, 2024

Study contacts

Stefano Frara, MD
Contact
frara.stefano@hsr.it
+390226435136
Gabriela Felipe, Nurse
Contact
felipe.gabriela@hsr.it
+390226435136

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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