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

NCT06344650 | Recruiting

• 1 other identifier: RF-2021-12373584
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acromegaly

Outcome Measures

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

  18 months

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acromegaly patients able to sign informed consent

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Fondazione Policlinico Universitario Campus Bio-Medico: collaborator
• Istituto Auxologico Italiano: collaborator

Study Sites (1)

Andrea Giustina

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Acromegaly

Interventions

Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Stefano Frara, MD

CONTACT

+390226435136; frara.stefano@hsr.it

Gabriela Felipe, Nurse

CONTACT

+390226435136; felipe.gabriela@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endocrinology

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: April 30, 2023
• Primary Completion: October 31, 2024
• Study Completion: April 1, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

IT (1)