Calcinosis Reduction by Pyrophosphate in SSC
Not Applicable
Not yet recruiting
- Conditions
- Systemic SclerosisScleroderma
- Interventions
- Dietary Supplement: PyrophosphateDietary Supplement: Placebo
- Registration Number
- NCT04966416
- Lead Sponsor
- Szeged University
- Brief Summary
Calcinosis, i.e. crystal-like nodules are troublesome complication of systemic sclerosis, an autoimmune disease. Pyrophosphate inhibits its formation is laborytory. We would like to test if orally administered pyrophosphate prevents calcinosis formation.
- Detailed Description
Calcinosis, the formation of hydroxyapatite subcutaneous nodules, often complicates systemic sclerosis. There is no standard treatment for it. Based upon our preclinical experienc, we would like to test it orally administered pyrophosphate inhibits calciosis.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- to meet ACR/ EULAR classification criteria
Exclusion Criteria
- severe upper minfestation of SSC
- hypo- or hyperthyreoidism
- QT prolongation on ECG
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pyrophosphate Pyrophosphate Disodium pyrophosphate Placebo Placebo Glucose
- Primary Outcome Measures
Name Time Method Change in the size of calcinosis nodues. 52 weeks+ 16 weeks Volumetric assessment with low energy CT
- Secondary Outcome Measures
Name Time Method Change of the size of calcinosis by ultrasound 52 weeks+ 16 weeks Volumetric assessment by ultrasound
Change of the severity of sympthoms caused by calcinosis 52 weeks+ 16 weeks Visual analogue scale (0-100)
Change of the activity of calcinosis 52 weeks+ 16 weeks Visual analogue scale (0-100)