- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04195529
Genetic Polymorphisms Associated With Vertebral Osteochondrosis (OSTEOGEN)
Evaluation of Polymorphisms in the Vitamin D Receptor and Involved in Inflammation Associated With Vertebral Osteochondrosis
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Alessandra Colombini
- Phone Number: 0266214067
- Email: alessandra.colombini@grupposandonato.it
Study Contact Backup
- Name: Elena Cittera
- Phone Number: 0266214057
- Email: elena.cittera@grupposandonato.it
Study Locations
-
-
Milan
-
Milano, Milan, Italy, 20161
- Recruiting
- IRCCS Istituto Ortopedico Galeazzi
-
Contact:
- Alessandra Colombini
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Alessandra Colombini, IRCCS Istituto Ortopedico Galeazzi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSTEOGEN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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