Systemic Sclerosis
Conditions
Brief summary
The present study recruits female patients aged 45-65 years with a diagnosis of Systemic Sclerosis according to the EULAR/ACR 2013 criteria and age and gender-matched healthy control subjects. The purpose of the study is to investigate the possible role of Klotho and other cytokines involved in the osteoimmunological control of bone turnover as a possible determinant of the microvascular damage and fibrosis observed in SSc patients
Detailed description
The present study recruits female patients aged 45-65 years with a diagnosis of Systemic Sclerosis according to the EULAR/ACR 2013 criteria and age and gender-matched healthy control subjects. The purpose of the study is to investigate the possible role of Klotho and other cytokines involved in the osteoimmunological control of bone turnover as a possible determinant of the microvascular damage and fibrosis observed in SSc patients . For each patient demographic data, history of fractures and smoking habits will be gathered. Evaluation of bone mineral density will be performed and blood samples to dose DDK1, sclerostin, osteoprotegerin and Klotho will be collected.
Interventions
OTHERPossible Klotho effects on SSc clinical conditions, namely skeletal, fibrotic and microangiopathic damage
Female patients with a diagnosis of Systemic Sclerosis ( EULAR/ACR 2013 criteria ) attending the FPG Department of Rheumatology will be recruited after exclusion criteria are ruled out and informed consent is signed. DXA bone mineral density determination (Lunar Prodigy ) will be performed and bone metabolism parameters, according to routinary clinical practice, will be collected. Immunological and SSc-related disease features will also be recorded. Fibrosis will be determined by the extent of cutaneous involvement (limited or diffuse) and modified Rodnan Skin Score. Microangiopathy will be assessed by videocapillaroscopy and presence of acral ulcers or acrosteolysis; Presence of calcinosis will also be assessed . Upon recruitment each SSc patient will undergo blood sampling, which will be centrifuged and stored at -80° until the day of the processing. Biomarkers (Klotho, OPG, DKK, and sclerostin) will be determined using commercial kit of the ELISA Immunoenzyme techniques
OTHEREvalution in healthy patients of bone mineral density, Klotho level and key bone-related cytokines
Healthy female control patients undergoing bone mineral density determination will be recruited upon exclusion criteria are ruled out. A detailed clinical history will be assessed and blood sempling will be processed for detection of bone-related cytokines
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Female gender * Systemic sclerosis diagnosis * Signature of the informed consent
Exclusion criteria
* Chronic kidney disease * Liver or thyroid disease * Diabetes * Ongoing diuretic treatment * Estrogen replacing treatment * Vitamin D or Calcium supplementation * Drugs able to interfere with bone turn-over (such as bisphosphonates or glucocorticoids)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Klotho serum levels in a group of 63 female SSc patients aged 45-65 years compared to 63 age and sex-matched healthy controls | 21 months | Klotho serum levels in each SSc and control subject will be determined by a commercial ELISA assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Klotho serum levels in female SSc patients: relationship to microvascular damage and fibrosis | 21 months | Evaluation of a possible relationship among Klotho serum levels, the extent and type of the microvascular damage assessed by videocapillaroscopy, and the extent of the cutaneous fibrotic involvement assessed by the modified Rodnan skin score (mRSS). |
| Klotho serum levels in female SSc patients: relationship to bone mineral density values | 21 months | Detection of a possible relationship between Klotho serum levels and bone mineral density values in female SSc patients stratified according to the extent of vascular and fibrotic damage |
| Klotho serum levels in female SSc patients relationship to key bone-related cytokine serum levels | 21 months | Assessment of a possible relationship among Klotho, DDK-1, OPG, and sclerostin serum levels |
Countries
Italy
Outcome results
None listed