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

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Osteoporosis; Lupus Erythematosus, Systemic

Treatments: Device: fan beam CT scan; Biological: RANKL/OPG ratio; Device: bone densitometry; Device: Doppler ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT02799173

PHRCIR09-PR-MAZIERE-MME

Details and patient eligibility

About

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

Enrollment: 74 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

74 participants in 1 patient group

Systemic lupus erythematosus

Experimental group

Description:

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

Treatment:

Device: Doppler ultrasound

Device: bone densitometry

Device: fan beam CT scan

Biological: RANKL/OPG ratio