This trial is active, not recruiting.

Conditions osteoporosis, lupus erythematosus, systemic
Treatments rankl/opg ratio, bone densitometry, fan beam ct scan, doppler ultrasound
Sponsor Centre Hospitalier Universitaire, Amiens
Start date April 2011
End date April 2017
Trial size 74 participants
Trial identifier NCT02799173, PHRCIR09-PR-MAZIERE-MME


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose basic science
RANKL/OPG ratio bone densitometry fan beam CT scan Doppler ultrasound
rankl/opg ratio
bone densitometry
fan beam ct scan
doppler ultrasound

Primary Outcomes

time frame: Day 0
presence of osteoporosis
time frame: Day 0

Eligibility Criteria

Female participants from 18 years up to 99 years old.

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

Additional Information

Official title Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification
Principal investigator Cécile MAZIERE, Md, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire, Amiens.