Genetic Polymorphisms Associated With Vertebral Osteochondrosis

• Conditions: Spinal Osteochondrosis

• Registration Number: NCT04195529
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Brief Summary

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.

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 Timeline

• Study Start: 2019-11-19
• Status Verified: 2019-12
• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-09
• Last Update Submitted: 2019-12-09
• Study First Posted: 2019-12-12
• Last Update Posted: 2019-12-12
• Primary Completion: 2020-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
association of spinal osteochondrosis with specific VDR genotypes	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 Outcome Measures

Name	Time	Method
association of spinal osteochondrosis with specific biochemical markers	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.

Trial Locations

Locations (1)

IRCCS Istituto ortopedico Galeazzi; 🇮🇹 Milano, Milan, Italy