Genetic Polymorphisms Associated With Vertebral Osteochondrosis (OSTEOGEN)

December 9, 2019 updated by: Istituto Ortopedico Galeazzi

Evaluation of Polymorphisms in the Vitamin D Receptor and Involved in Inflammation Associated With Vertebral Osteochondrosis

The present study is proposed for the identification of phenotype, biochemical and genetic markers in adult symptomatic spinal osteochondrosis to promote the early diagnosis of this pathological condition and to establish possible therapeutic targets that favor a conservative approach aimed at treating patients.

Study Overview

Status

Unknown

Detailed Description

The primary outcome is to determine the association between specific phenotypic characteristics of osteochondrosis, in particular linked to osteo-cartilaginous degeneration, with the identified vitamin D receptor genotypes.

The secondary outcomes are to evaluate the circulating levels of the osteo-cartilage degradation markers, of the vitamin D and to evaluate the association of the osteochondrosis phenotype with variants in genes involved in inflammatory processes.

Study Type

Observational

Enrollment (Anticipated)

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

    • Milan
      • Milano, Milan, Italy, 20161
        • Recruiting
        • IRCCS Istituto Ortopedico Galeazzi
        • Contact:
          • Alessandra Colombini

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

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

70-100 adult male and female patients suffering from osteochondrosis and disc degeneration evidenced by MRI will be enrolled, after signing the informed consent, at the Galeazzi Orthopedic Institute.

Description

Inclusion criteria

  • males and females
  • 18≤age ≤ 65 years old
  • patients with adult spinal osteochondrosis Exclusion criteria
  • age < 18 or > 65 years old
  • chronic major diseases such as diabetes, autoimmune diseases, cardiovascular diseases, malignancies

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
association of spinal osteochondrosis with specific VDR genotypes
Time Frame: 1st year
Determine the association between specific phenotypic characteristics of osteochondrosis identified by means of MRI, in particular the presence of wavy/Irregular, notched endplates or Shmorl's nodes with FokI, BsmI, ApaI, TaqI VDR genotypes, assessed by means of TaqMan SNP Genotyping Assays
1st year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
association of spinal osteochondrosis with specific biochemical markers
Time Frame: 2nd year
Determine the association between specific phenotypic characteristics of osteochondrosis identified by means of MRI, in particular the presence of wavy/Irregular, notched endplates or Shmorl's nodes with the circulating levels of the osteo-cartilage degradation markers CTx-I, CTx-II and of the vitamin D.
2nd year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
association of spinal osteochondrosis with specific inflammatory genotypes
Time Frame: 1st year
Exploratory evaluation of the association of the osteochondrosis phenotype with variants in genes involved in inflammatory processes, such as IL-1B and IL-1RN.
1st year

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Alessandra Colombini, IRCCS Istituto Ortopedico Galeazzi

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)

November 19, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 5, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (Actual)

December 12, 2019

Study Record Updates

Last Update Posted (Actual)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 9, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Clinical Trials on Spinal Osteochondrosis

Clinical Trials on presence of genetic variants

Subscribe