Genetic Polymorphisms Associated With Vertebral Osteochondrosis

Spinal Osteochondrosis Clinical Trial

— OSTEOGEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04195529
• Other study ID #: OSTEOGEN
• Status: Recruiting
• Start date: November 19, 2019
• Est. completion date: December 2022

Study information

• Verified date: December 2019
• Source: Istituto Ortopedico Galeazzi
• Contact: Alessandra Colombini
• Phone: 0266214067
• Email: alessandra.colombini[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Scheuermann Disease
• Spinal Osteochondrosis

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Istituto ortopedico Galeazzi	Milano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	association of spinal osteochondrosis with specific inflammatory genotypes	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
Primary	association of spinal osteochondrosis with specific VDR genotypes	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	association of spinal osteochondrosis with specific biochemical markers	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