Klotho and Mineral Bone Density in Systemic Sclerosis

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Systemic Sclerosis

Treatments: Other: Evalution in healthy patients of bone mineral density, Klotho level and key bone-related cytokines; Other: Possible Klotho effects on SSc clinical conditions, namely skeletal, fibrotic and microangiopathic damage

Study type: Observational

Funder types: Other

Identifiers

NCT05777954

4633

Details and patient eligibility

About

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

Full 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.

Enrollment: 126 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

126 participants in 2 patient groups

Systemic Sclerosis patients

Description:

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.

Treatment:

Other: Possible Klotho effects on SSc clinical conditions, namely skeletal, fibrotic and microangiopathic damage

Healthy subjects

Description:

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.

Treatment:

Other: Evalution in healthy patients of bone mineral density, Klotho level and key bone-related cytokines