Genetic Polymorphisms Associated With Vertebral Osteochondrosis
OSTEOGEN
Evaluation of Polymorphisms in the Vitamin D Receptor and Involved in Inflammation Associated With Vertebral Osteochondrosis
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 19, 2019
CompletedFirst Submitted
Initial submission to the registry
December 5, 2019
CompletedFirst Posted
Study publicly available on registry
December 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedDecember 12, 2019
December 1, 2019
1 year
December 5, 2019
December 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
association of spinal osteochondrosis with specific biochemical markers
2nd year
Other Outcomes (1)
association of spinal osteochondrosis with specific inflammatory genotypes
1st year
Interventions
identification of the presence of genetic variants
Eligibility Criteria
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.
You may qualify if:
- males and females
- ≤age ≤ 65 years old
You may not qualify if:
- age \< 18 or \> 65 years old
- chronic major diseases such as diabetes, autoimmune diseases, cardiovascular diseases, malignancies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Istituto ortopedico Galeazzi
Milan, Milan, 20161, Italy
Biospecimen
whole blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alessandra Colombini
IRCCS Istituto Ortopedico Galeazzi
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2019
First Posted
December 12, 2019
Study Start
November 19, 2019
Primary Completion
December 1, 2020
Study Completion
December 1, 2022
Last Updated
December 12, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share