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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systemic Sclerosis patients | Female patients with systemic sclerosis with an age between 45 and 65 years old and did not met the exclusion criteria. Blood sample were collected to determine DKK1, Sclerostin Klotho and Osteoprotegerin. Bone mineral density was assessed. No drug was tested during the study. |
| |
| Healthy subjects | Female patients with no history of inflammatory rheumatic disease and who di not met the exclusion criteria. Blood sample were collected to determine DKK1, Sclerostin Klotho and Osteoprotegerin. Bone mineral density was assessed. No drug was tested during the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Possible Klotho effects on SSc clinical conditions, namely skeletal, fibrotic and microangiopathic damage | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Klotho serum levels in each SSc and control subject will be determined by a commercial ELISA assay | 21 months |
| Measure | Description | Time Frame |
|---|---|---|
| Klotho serum levels in female SSc patients: relationship to microvascular damage and fibrosis | 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). | 21 months |
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Inclusion Criteria:
Exclusion Criteria:
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Female patients with a diagnosis of Systemic Sclerosis according to the EULAR/ACR 2013 criteria and followed by the FPG-IRCSS Rheumatology Department will be progressively recruited, after exclusion criteria are ruled out and informed consent is signed.
Concomitantly healthy control female patients undergoing bone mineral density determination are recruited, once exclusion criteria are ruled out.
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| Name | Affiliation | Role |
|---|---|---|
| Luisa Mirone | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Rheumatology, Fondazione Policlinico Universitario A.Gemelli IRCCS | Rome | Lazio | 00168 | Italy |
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two blood samples to dose DKK-1, sclerostin, Osteoprotegerin and Klotho
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| Evalution in healthy patients of bone mineral density, Klotho level and key bone-related cytokines | Other | 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 |
|
| Klotho serum levels in female SSc patients: relationship to bone mineral density values | 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 | 21 months |
| Klotho serum levels in female SSc patients relationship to key bone-related cytokine serum levels | Assessment of a possible relationship among Klotho, DDK-1, OPG, and sclerostin serum levels | 21 months |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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