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Genetic Polymorphisms Associated With Vertebral Osteochondrosis (OSTEOGEN)

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ClinicalTrials.gov Identifier: NCT04195529
Recruitment Status : Recruiting
First Posted : December 12, 2019
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

Tracking Information
First Submitted Date December 5, 2019
First Posted Date December 12, 2019
Last Update Posted Date December 12, 2019
Actual Study Start Date November 19, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 9, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 9, 2019)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 9, 2019)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Genetic Polymorphisms Associated With Vertebral Osteochondrosis
Official Title Evaluation of Polymorphisms in the Vitamin D Receptor and Involved in Inflammation Associated With Vertebral Osteochondrosis
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood samples
Sampling Method Probability Sample
Study Population 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.
Condition Spinal Osteochondrosis
Intervention Genetic: presence of genetic variants
identification of the presence of genetic variants
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 9, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Alessandra Colombini 0266214067 alessandra.colombini@grupposandonato.it
Contact: Elena Cittera 0266214057 elena.cittera@grupposandonato.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04195529
Other Study ID Numbers OSTEOGEN
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Istituto Ortopedico Galeazzi
Study Sponsor Istituto Ortopedico Galeazzi
Collaborators Not Provided
Investigators
Principal Investigator: Alessandra Colombini IRCCS Istituto Ortopedico Galeazzi
PRS Account Istituto Ortopedico Galeazzi
Verification Date December 2019