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

Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06344650

Enrollment

100

Registered

2024-04-03

Start date

2023-04-30

Completion date

2026-04-30

Last updated

2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Brief summary

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

Interventions

OTHERQuestionnaires

Compilation of questionnaires (AcroQol, SF-36)

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

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Identify the rate of morphometric vertebral fractures in acromegalic patients	18 months	Identify the rate of morphometric vertebral fractures in acromegalic patients 18 months after hospitalization for neurosurgery

Countries

Italy

Contacts

Primary ContactStefano Frara, MD

frara.stefano@hsr.it+390226435136

Backup ContactGabriela Felipe, Nurse

felipe.gabriela@hsr.it+390226435136

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026