NCT02799173

Brief Summary

Patients with Systemic lupus erythematosus (SLE) are known to present an increased risk of osteoporosis and cardiovascular calcification. It has also been suggested that bone remodelling and cardiovascular calcification are regulated by the same mechanisms, but inversely in terms of calcium deposition, as osteoporosis is often associated with cardiovascular calcification. Inflammatory and immune factors have been implicated in these two processes. The role of the RANKL/OPG system in osteoclast differentiation has been elucidated over the last ten years. RANKL induces differentiation of monocytes-macrophages into osteoclasts, while, inversely, OPG exerts an inhibitory role by inactivating RANKL. Differentiation of smooth muscle cells into osteoblasts in the vessel wall induces calcification, and this phenomenon is counterbalanced by differentiation of monocytes into osteoclasts. Although the role of the RANKL/OPG ratio in the pathogenesis of osteoporosis has now been clearly established, its role in vascular calcification is only hypothetical at the present time. This study will focus on patients with SLE diagnosed and followed in the Amiens University Hospital Internal Medicine and Nephrology departments

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

April 15, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

4.2 years

First QC Date

June 10, 2016

Last Update Submit

August 9, 2018

Conditions

OsteoporosisLupus Erythematosus, Systemic

Keywords

cardiovascular calcificationRANK: Receptor Activator of Nuclear Factor kappa BRANKL: Receptor Activator of Nuclear Factor kappa B LigandOPG: OsteoprotegerinSLE: Systemic lupus erythematosus

Outcome Measures

Primary Outcomes (2)

  • RANKL/OPG ratio

    Day 0

  • presence of osteoporosis

    Day 0

Study Arms (1)

Systemic lupus erythematosus

EXPERIMENTAL

RANKL/OPG ratio bone densitometry fan beam CT scan Doppler ultrasound

Biological: RANKL/OPG ratioDevice: bone densitometryDevice: fan beam CT scanDevice: Doppler ultrasound

Interventions

RANKL/OPG ratioBIOLOGICAL
Systemic lupus erythematosus
bone densitometryDEVICE
Systemic lupus erythematosus
fan beam CT scanDEVICE
Systemic lupus erythematosus
Doppler ultrasoundDEVICE
Systemic lupus erythematosus

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women over 18 years old
  • suffering from systemic lupus erythematosus.

You may not qualify if:

  • underlying diseases that can lead to bone and cardiovascular metabolic disturbances :
  • Malignancies such as cancer metastasized
  • Autoimmune disease other than LED or of overlap syndrome ( rhupus , MCTD )
  • Infection by HIV, hepatitis B and C
  • Hepatic Cirrhosis
  • Chronic renal failure
  • Parathyroid disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Amiens

Amiens, 80054, France

Location

CHU Rouen

Rouen, 76031, France

Location

MeSH Terms

Conditions

OsteoporosisLupus Erythematosus, Systemic

Interventions

Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Cécile MAZIERE, Md, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2016

First Posted

June 14, 2016

Study Start

April 15, 2011

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

FR(2)