Klotho and Mineral Bone Density in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

Official title:

Klotho and Bone Mineral Density (BMD) in Systemic Sclerosis Patients: Relationship With Microvascular Damage and Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05777954
• Other study ID #: 4633
• Status: Recruiting
• Start date: March 21, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Livia Rossi Massimi
• Phone: 0630154307
• Email: segreteria.reumatologia[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 31, 2023
• Est. primary completion date: March 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• Possible 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
• Evalution 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

Locations

Country	Name	City	State
Italy	Division of Rheumatology, Fondazione Policlinico Universitario A.Gemelli IRCCS	Rome	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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