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

August 20, 2024 updated by: Andrea Giustina, IRCCS San Raffaele

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Acromegaly patients able to sign informed consent

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Collaborators

Istituto Auxologico Italiano
Fondazione Policlinico Universitario Campus Bio-Medico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RF-2021-12373584

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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