Clinical Trials Logo
  1. Home
  2. Acromegaly
  3. NCT06344650
  4. Details
NCT06344650 Clinical Trial

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

Acromegaly Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06344650
Other study ID # RF-2021-12373584
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 28, 2023
Est. completion date July 2024

Study information
Verified date March 2024
Source IRCCS San Raffaele
Contact Stefano Frara, Medical doctor
Phone +390226435136
Email frara.stefano@hsr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Prospective observational clinical, molecular, translational and basic study aimed at identifying the main determinants and predictive factors of risk of bone damage in acromegaly patients

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood sample
Collection of blood serum for molecular and biochemical tests, performance of radiological tests (DXA, VFA, TBS, BSi, HR-pQCT), compilation of questionnaires (AcroQol, SF-36), DXA morphometry

Locations
Country Name City State
Italy Andrea Giustina Milan

Sponsors (3)
Lead Sponsor Collaborator
IRCCS San Raffaele Fondazione Policlinico Universitario Campus Bio-Medico, Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02092129 - Pituitary Histopathology and Hyperprolactinaemia and Risk of Glucose Metabolic Disturbances in Acromegaly. N/A
Completed NCT02012127 - Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
Active, not recruiting NCT01265121 - Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism. N/A
Terminated NCT00765323 - Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly Phase 3
Completed NCT00531908 - Physiopathology of Sodium Retention in Acromegaly N/A
Completed NCT00500227 - Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
Completed NCT01278342 - Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Phase 4
Active, not recruiting NCT01809808 - A Prospective Study of Outcome After Therapy for Acromegaly
Completed NCT00145405 - Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction Phase 4
Completed NCT00210457 - Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Phase 3
Recruiting NCT05401084 - Diet in the Management of Acromegaly N/A
Recruiting NCT00005100 - Measurement of Outcome of Surgical Treatment in Patients With Acromegaly N/A
Completed NCT00521300 - Preoperative Octreotide Treatment of Acromegaly Phase 4
Completed NCT03548415 - Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands Phase 2
Not yet recruiting NCT04066569 - Reproducibility and Utility of OGTT in Acromegaly N/A
Not yet recruiting NCT05298891 - Hypoproteic Diet in Acromegaly N/A
Recruiting NCT04520646 - A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy N/A
Not yet recruiting NCT04529356 - The TMS Treatment for Postoperative Headache in GH Tumor N/A
Active, not recruiting NCT03252353 - Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly Phase 3
Completed NCT02934399 - Dynamic Hormone Diagnostics in Endocrine Disease