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

NCT ID: NCT06344650

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-30

Study Completion Date

2026-04-30

Brief Summary

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

Detailed Description

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Conditions

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Acromegaly

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Interventions

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Blood sample

Collection of blood serum for molecular and biochemical tests

Intervention Type PROCEDURE

Radiological tests

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

Intervention Type DIAGNOSTIC_TEST

Questionnaires

Compilation of questionnaires (AcroQol, SF-36)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Campus Bio-Medico

OTHER

Sponsor Role collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role collaborator

IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Andrea Giustina

Head of Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Andrea Giustina

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Stefano Frara, MD

Role: CONTACT

+390226435136

Gabriela Felipe, Nurse

Role: CONTACT

+390226435136

Facility Contacts

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Gabriela Felipe

Role: primary

0226435062

Other Identifiers

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RF-2021-12373584

Identifier Type: -

Identifier Source: org_study_id

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