Genotype-related Molecular Targets in the Vitamin D Pathway for Spinal Disc Diseases

Intervertebral Disk Degeneration Clinical Trial

— GenVDisc  

Official title:

Identification of Genotype-related Molecular Targets in the Vitamin D Pathway for Personalized Pharmacological Treatments of the Spinal Disc Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03343899
• Other study ID #: GenVDisc
• Status: Recruiting
• Phase: N/A
• First received: November 10, 2017
• Last updated: November 10, 2017
• Start date: February 17, 2016
• Est. completion date: February 17, 2019

Study information

• Verified date: November 2017
• Source: Istituto Ortopedico Galeazzi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: February 17, 2019
• Est. primary completion date: February 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

patients with spinal disc diseases

• males and females

• 18=age = 70 years old

• Italian white

• patients with spinal disc diseases that will be surgically treated

Exclusion criteria:

• age < 18 or > 70 years old

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Intervertebral Disk Degeneration

Locations

Country	Name	City	State
Italy	Alessandra Colombini	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disc cell functional response genotype-based	To characterize cells obtained from different disc tissues (nucleus pulposus, annulus fibrosus, cartilage endplate) and to evaluate their VDR FokI genotype-related response to vitamin D treatment, regulating the cell proliferation and phenotype.	2 years