Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess.
ConditionAcromegaly
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
Prospective observational clinical, molecular, translational study aimed at identifying the main determinants and predictive factors of fragility fracture risck in acromegaly patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
confirmed diagnosis of acromegaly
availability to carry out outpatient checks
ability to provide informed consent
Disqualifiers
Pregnancy
use of glucocorticoids (except those in use for replacement therapy)
alcohol abuse
exacerbation of chronic disease
Trial population
Acromegaly patients able to sign informed consent
Trial design
Design model
Case-crossover
Time perspective
Prospective
Treatments tested in this trial
Blood sample
Procedure/SurgeryCollection of blood serum for molecular and biochemical tests
Radiological tests
Diagnostic testPerformance of radiological tests (DXA, VFA, TBS, BSi, HR-pQCT) and DXA morphometry
Questionnaires
Other interventionCompilation of questionnaires (AcroQol, SF-36)
Treatment groups
No treatment groups listed
Trial outcomes
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS San Raffaele
Lead sponsor
IRCCS Ospedale San Raffaele
Sponsor institution
Fondazione Policlinico Universitario Campus Bio-Medico
Collaborator
Istituto Auxologico Italiano
Collaborator
Source ClinicalTrials.gov