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Genetic Polymorphisms Associated With Vertebral Osteochondrosis

NCT ID: NCT04195529

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-19

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Spinal Osteochondrosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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presence of genetic variants

identification of the presence of genetic variants

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* males and females
* 18≤age ≤ 65 years old

Exclusion Criteria

* age \< 18 or \> 65 years old
* chronic major diseases such as diabetes, autoimmune diseases, cardiovascular diseases, malignancies
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alessandra Colombini

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Ortopedico Galeazzi

Locations

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IRCCS Istituto ortopedico Galeazzi

Milan, Milan, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessandra Colombini

Role: CONTACT

Phone: 0266214067

Email: [email protected]

Elena Cittera

Role: CONTACT

Phone: 0266214057

Email: [email protected]

Facility Contacts

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Alessandra Colombini

Role: primary

Other Identifiers

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OSTEOGEN

Identifier Type: -

Identifier Source: org_study_id