Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Genetic Polymorphisms Associated With Vertebral Osteochondrosis (OSTEOGEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
Spinal Osteochondrosis Genetic: presence of genetic variants

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Polymorphisms in the Vitamin D Receptor and Involved in Inflammation Associated With Vertebral Osteochondrosis
Actual Study Start Date : November 19, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.


Biospecimen Retention:   Samples With DNA
whole blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04195529


Contacts
Layout table for location contacts
Contact: Alessandra Colombini 0266214067 alessandra.colombini@grupposandonato.it
Contact: Elena Cittera 0266214057 elena.cittera@grupposandonato.it

Locations
Layout table for location information
Italy
IRCCS Istituto ortopedico Galeazzi Recruiting
Milano, Milan, Italy, 20161
Contact: Alessandra Colombini         
Sponsors and Collaborators
Istituto Ortopedico Galeazzi
Investigators
Layout table for investigator information
Principal Investigator: Alessandra Colombini IRCCS Istituto Ortopedico Galeazzi
Layout table for additonal information
Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT04195529    
Other Study ID Numbers: OSTEOGEN
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteochondrosis
Spinal Osteochondrosis
Scheuermann Disease
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Kyphosis
Spinal Curvatures