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

Not Applicable

Completed

• Conditions: Osteoporosis; Lupus Erythematosus, Systemic
• Interventions: Biological: RANKL/OPG ratio; Device: bone densitometry; Device: fan beam CT scan; Device: Doppler ultrasound

• Registration Number: NCT02799173
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-15
• Primary Completion: 2015-07-01
• Study Completion: 2015-07-01
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-14
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Systemic lupus erythematosus	RANKL/OPG ratio	RANKL/OPG ratio bone densitometry fan beam CT scan Doppler ultrasound
Systemic lupus erythematosus	fan beam CT scan	RANKL/OPG ratio bone densitometry fan beam CT scan Doppler ultrasound
Systemic lupus erythematosus	bone densitometry	RANKL/OPG ratio bone densitometry fan beam CT scan Doppler ultrasound
Systemic lupus erythematosus	Doppler ultrasound	RANKL/OPG ratio bone densitometry fan beam CT scan Doppler ultrasound

Primary Outcome Measures

Name	Time	Method
RANKL/OPG ratio	Day 0
presence of osteoporosis	Day 0

Trial Locations

Locations (2)

CHU Rouen; 🇫🇷 Rouen, France

CHU Amiens; 🇫🇷 Amiens, France