OsteoporosisCALCILUPNCT02799173
Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification
A study testing RANKL/OPG ratio, bone densitometry and fan beam CT scan in people with Osteoporosis and Lupus Erythematosus, Systemic, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Osteoporosis, Lupus Erythematosus, Systemic
- What is being tested?
- RANKL/OPG ratio, bone densitometry and fan beam CT scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Apr 2011to 1 Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over 18 years old
- suffering from systemic lupus erythematosus.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
About this study
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
- Conditions
- Osteoporosis, Lupus Erythematosus, Systemic
- Being tested
- RANKL/OPG ratio, bone densitometry, fan beam CT scan, Doppler ultrasound
- 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
- Medical subject headings
- Osteoporosis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RANKL/OPG ratioBiological
bone densitometryDevice
fan beam CT scanDevice
Doppler ultrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| Systemic lupus erythematosus | Experimental | RANKL/OPG ratio bone densitometry fan beam CT scan Doppler ultrasound Receives: Biological: RANKL/OPG ratio; Device: bone densitometry; Device: fan beam CT scan; Device: Doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
RANKL/OPG ratio
Measured: Day 0
presence of osteoporosis
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start15 Apr 2011
- Primary completion1 Jul 2015
- Study completion1 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile MAZIERE, Md, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799173
- Sponsor's protocol ID
- PHRCIR09-PR-MAZIERE-MME
- Acronym
- CALCILUP
- Status last verified
- Aug 2018
- First submitted
- 10 Jun 2016
- Last updated
- 10 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification
- ClinicalTrials.gov ID
- NCT02799173
- Acronym / sponsor ID
- CALCILUP / PHRCIR09-PR-MAZIERE-MME
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 15 Apr 2011 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systemic lupus erythematosus | Experimental | Biological: RANKL/OPG ratio, Device: bone densitometry, Device: fan beam CT scan, Device: Doppler ultrasoundRANKL/OPG ratio bone densitometry fan beam CT scan Doppler ultrasound |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women over 18 years old
- suffering from systemic lupus erythematosus.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RANKL/OPG ratio | Biological | Systemic lupus erythematosus |
| bone densitometry | Device | Systemic lupus erythematosus |
| fan beam CT scan | Device | Systemic lupus erythematosus |
| Doppler ultrasound | Device | Systemic lupus erythematosus |
Primary outcome
RANKL/OPG ratio
Time frame: Day 0
presence of osteoporosis
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile MAZIERE, Md, PhD principal investigator
CHU Amiens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RANKL/OPG ratio, bone densitometry and fan beam CT scan in people with Osteoporosis and Lupus Erythematosus, Systemic, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RANKL/OPG ratio (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.