Klotho and Bone Mineral Density (BMD) in Systemic Sclerosis Patients: Relationship with Microvascular Damage and Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female gender
- •Systemic sclerosis diagnosis
- •Signature of the informed consent
排除标准
- •Chronic kidney disease
- •Liver or thyroid disease
- •Ongoing diuretic treatment
- •Estrogen replacing treatment
- •Vitamin D or Calcium supplementation
- •Drugs able to interfere with bone turn-over (such as bisphosphonates or glucocorticoids)
结局指标
主要结局
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
时间窗: 21 months
Klotho serum levels in each SSc and control subject will be determined by a commercial ELISA assay
次要结局
- Klotho serum levels in female SSc patients: relationship to microvascular damage and fibrosis(21 months)
- Klotho serum levels in female SSc patients relationship to key bone-related cytokine serum levels(21 months)
- Klotho serum levels in female SSc patients: relationship to bone mineral density values(21 months)
研究者
Mirone Luisa
Assistant Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS