Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification

NCT ID: NCT02799173

Last Updated: 2018-08-10

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

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-15

Study Completion Date

2015-07-01

Brief Summary

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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

Detailed Description

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Conditions

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Osteoporosis Lupus Erythematosus, Systemic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Systemic lupus erythematosus

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

Group Type EXPERIMENTAL

RANKL/OPG ratio

Intervention Type BIOLOGICAL

bone densitometry

Intervention Type DEVICE

fan beam CT scan

Intervention Type DEVICE

Doppler ultrasound

Intervention Type DEVICE

Interventions

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RANKL/OPG ratio

Intervention Type BIOLOGICAL

bone densitometry

Intervention Type DEVICE

fan beam CT scan

Intervention Type DEVICE

Doppler ultrasound

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cécile MAZIERE, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status

CHU Rouen

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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PHRCIR09-PR-MAZIERE-MME

Identifier Type: -

Identifier Source: org_study_id

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