NCT03343899

Brief Summary

The objective of our study will be to analyze the interplay between particular VDR variants and its ligand in cells obtained from intervertebral disc and cartilage endplate and their action on cell proliferation and phenotype maintenance. The identification of novel molecular targets in the vitamin D pathway, potentially promoting pathological alterations of the tissues involved in spinal disc diseases, will allow to develop innovative and more personalized preventive and pharmacological/nutritional therapies.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2019

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

November 10, 2017

Last Update Submit

November 10, 2017

Conditions

Intervertebral Disk Degeneration

Outcome Measures

Primary Outcomes (1)

  • Phenotype and genotype characterization

    To evaluate structural alterations of the intervertebral disc and of the cartilage endplate in patients with spinal disc diseases related to functional FokI polymorphism in the vitamin D receptor (VDR) gene.

    1 year

Secondary Outcomes (1)

  • Disc cell functional response genotype-based

    2 years

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with spinal disc diseases

You may qualify if:

  • patients with spinal disc diseases
  • males and females
  • ≤age ≤ 70 years old
  • Italian white
  • patients with spinal disc diseases that will be surgically treated

You may not qualify if:

  • \- age \< 18 or \> 70 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alessandra Colombini

Milan, 20161, Italy

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2017

First Posted

November 17, 2017

Study Start

February 17, 2016

Primary Completion

February 17, 2018

Study Completion

February 17, 2019

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

IT(1)