Klotho and Mineral Bone Density in Systemic Sclerosis

Recruiting

• Conditions: Systemic Sclerosis
• Interventions: 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

• Registration Number: NCT05777954
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-03-21
• Study First Submitted: 2023-02-21
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-08
• Last Update Submitted: 2023-03-08
• Primary Completion: 2023-03-21
• Study First Posted: 2023-03-21
• Last Update Posted: 2023-03-21
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

• Female gender
• Systemic sclerosis diagnosis
• Signature of the informed consent

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy subjects	Evalution in healthy patients of bone mineral density, Klotho level and key bone-related cytokines	-
Systemic Sclerosis patients	Possible Klotho effects on SSc clinical conditions, namely skeletal, fibrotic and microangiopathic damage	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 key bone-related cytokine serum levels	21 months	Assessment of a possible relationship among Klotho, DDK-1, OPG, and sclerostin serum levels
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

Trial Locations

Locations (1)

Division of Rheumatology, Fondazione Policlinico Universitario A.Gemelli IRCCS; 🇮🇹 Rome, Lazio, Italy