NCT02829476

Brief Summary

Adolescent idiopathic Scoliosis (AIS) is the most common spine pathology. It is opposed to secondary scoliosis due to chronic diseases. Many hypotheses have been made to elucidate the origin of this illness. Recently, the melatonin pathway has been investigated as pinealectomy of the chicken creates a scoliosis that resembles AIS and melatonin supplementation reverses the process. In addition administration of melatonin to AIS patients improved the pathology. However this hypothesis has shown controversial results. Recent studies have demonstrated melatonin cellular resistance in osteoblastic cells from AIS patients. Melatonin acts through G protein coupled receptor (GPCR), mainly using the Gi pathway. In AIS osteoblasts, this pathway is blocked leading to a decrease in the inactivation of the adenylyl cyclase and therefore maintenance of high level of cyclic adenosine monophosphate (cAMP) concentrations in the cells. As modulation of cAMP is important for osteogenesis such resistance may be critical for the initiation or the development of AIS. Gi signalization is used by several other GPCR, thus, this hormonal resistance could logically be found in other hormonal or mediator pathways. A precedent study previously focused on ghrelin in AIS, and demonstrated that AIS patients possess elevated plasmatic values of ghrelin. This study also observed decreased response to ghrelin in AIS cultures osteoblasts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

July 4, 2016

Last Update Submit

May 10, 2017

Conditions

Scoliosis

Keywords

Adolescent idiopathic ScoliosisGhrelin

Outcome Measures

Primary Outcomes (1)

  • Testing ghrelin cellular resistance by intracellular cAMP dosage

    Testing ghrelin cellular resistance in AIS by measuring the variation of the intracellular cAMP level in response to ghrelin in osteoblast cells in vitro of AIS patients versus controls

    baseline

Secondary Outcomes (2)

  • ghrelin level in serum

    baseline

  • ghrelin levels in cellular supernatants

    baseline

Study Arms (2)

patients with AIS

EXPERIMENTAL

Patients will have 'Osteoblast sample'

Biological: Osteoblast sample

control patients

EXPERIMENTAL
Biological: Osteoblast sample

Interventions

Osteoblast sampleBIOLOGICAL

culture osteoblasts obtained from vertebrae fragments from 30 patients with AIS and from 10 control patients with secondary scoliosis

control patientspatients with AIS

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Group 1 :
  • AIS : spine deformity with angle above 10°,without detected cause
  • Informed consent obtained
  • Group 2 :
  • Secondary scoliosis due to chronic illness, neurologic or syndromic, eligible for spine surgery
  • Spine surgery for reason other than scoliosis
  • Informed consent obtained

You may not qualify if:

  • Not primary scoliosis
  • No consent
  • Legal obstacle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31000, France

Location

Related Publications (1)

  • Sales de Gauzy J, Gennero I, Delrous O, Salles JP, Lepage B, Accadbled F. Fasting total ghrelin levels are increased in patients with adolescent idiopathic scoliosis. Scoliosis. 2015 Nov 30;10:33. doi: 10.1186/s13013-015-0054-7. eCollection 2015.

    PMID: 26628906RESULT

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • SALLES Jean-Pierre, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2016

First Posted

July 12, 2016

Study Start

March 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

May 12, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)