Cellular, Molecular and Clinical Determinants of Bone Str... | NCT06344650

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

NCT06344650

Sponsor

IRCCS San Raffaele

Status

Recruiting

Last Update Posted

Aug 22, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Acromegaly

Interventions

Blood sample
Radiological tests
Questionnaires

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2023Actual

Primary Completion Date

Oct 31, 2024Estimated

Completion Date

Apr 2026Estimated

First Submitted Date

Mar 27, 2024

First Submission Date that Met QC Criteria

Mar 27, 2024

First Posted Date

Apr 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2024

Last Update Posted Date

Aug 22, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrea Giustina, Head of Endocrinology, IRCCS Ospedale San RaffaelePrincipal Investigator

Lead Sponsor

IRCCS San RaffaeleOTHER

Collaborators

Name	Class
Fondazione Policlinico Universitario Campus Bio-Medico	OTHER
Istituto Auxologico Italiano	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
Blood sample	Procedure	Collection of blood serum for molecular and biochemical tests
Radiological tests	Diagnostic Test	Performance of radiological tests (DXA, VFA, TBS, BSi, HR-pQCT) and DXA morphometry
Questionnaires	Other	Compilation of questionnaires (AcroQol, SF-36)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)
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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Acromegaly patients able to sign informed consent

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stefano Frara, MD	Contact	+390226435136		frara.stefano@hsr.it
Gabriela Felipe, Nurse	Contact	+390226435136		felipe.gabriela@hsr.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Andrea Giustina	Recruiting	Milan		20132	Italy

Condition Browse Module

MeSH Terms

ID	Term
D000172	Acromegaly

Ancestor Terms

ID	Term
D001849	Bone Diseases, Endocrine
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006964	Hyperpituitarism

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided