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NCT Number: NCT06344650

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

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

Recruiting

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. Identify the rate of morphometric vertebral fractures in acromegalic patients

    Time frame: 18 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriela Felipe, Nurse

CONTACT

[email protected]

+390226435136

Stefano Frara, MD

CONTACT

[email protected]

+390226435136

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

  • Fondazione Policlinico Universitario Campus Bio-Medico
  • Istituto Auxologico Italiano

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Apr 3, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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