Back to resultsDetermination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification (CALCILUP)
Primary Purpose
Osteoporosis, Lupus Erythematosus, Systemic
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
RANKL/OPG ratio
bone densitometry
fan beam CT scan
Doppler ultrasound
Sponsored by
About this trial
This is an interventional basic science trial for Osteoporosis focused on measuring cardiovascular calcification, RANK: Receptor Activator of Nuclear Factor kappa B, RANKL: Receptor Activator of Nuclear Factor kappa B Ligand, OPG: Osteoprotegerin, SLE: Systemic lupus erythematosus
Eligibility Criteria
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
Sites / Locations
- CHU Amiens
- CHU Rouen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Systemic lupus erythematosus
Arm Description
RANKL/OPG ratio bone densitometry fan beam CT scan Doppler ultrasound
Outcomes
Primary Outcome Measures
RANKL/OPG ratio
presence of osteoporosis
Secondary Outcome Measures
Full Information
NCT ID
NCT02799173
First Posted
June 10, 2016
Last Updated
August 9, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT02799173
Brief Title
Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification
Acronym
CALCILUP
Official Title
Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 15, 2011 (Actual)
Primary Completion Date
July 1, 2015 (Actual)
Study Completion Date
July 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Lupus Erythematosus, Systemic
Keywords
cardiovascular calcification, RANK: Receptor Activator of Nuclear Factor kappa B, RANKL: Receptor Activator of Nuclear Factor kappa B Ligand, OPG: Osteoprotegerin, SLE: Systemic lupus erythematosus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systemic lupus erythematosus
Arm Type
Experimental
Arm Description
RANKL/OPG ratio bone densitometry fan beam CT scan Doppler ultrasound
Intervention Type
Biological
Intervention Name(s)
RANKL/OPG ratio
Intervention Type
Device
Intervention Name(s)
bone densitometry
Intervention Type
Device
Intervention Name(s)
fan beam CT scan
Intervention Type
Device
Intervention Name(s)
Doppler ultrasound
Primary Outcome Measure Information:
Title
RANKL/OPG ratio
Time Frame
Day 0
Title
presence of osteoporosis
Time Frame
Day 0
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile MAZIERE, Md, PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
Learn more about this trial
Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification
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