Genetic Polymorphisms Associated With Vertebral Osteochondrosis

Overview

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.

Full Title of Study: “Evaluation of Polymorphisms in the Vitamin D Receptor and Involved in Inflammation Associated With Vertebral Osteochondrosis”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2020

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.

Interventions

  • Genetic: presence of genetic variants
    • identification of the presence of genetic variants

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • I.R.C.C.S Ospedale Galeazzi-Sant’Ambrogio
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alessandra Colombini, Principal Investigator, IRCCS Istituto Ortopedico Galeazzi
  • Overall Contact(s)
    • Alessandra Colombini, 0266214067, alessandra.colombini@grupposandonato.it

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