Klotho and Mineral Bone Density in Systemic Sclerosis

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Recruiting

CT.gov ID

NCT05777954

Collaborator

(none)

126

Enrollment

Location

21.4

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Systemic Sclerosis	Other: Possible Klotho effects on SSc clinical conditions, namely skeletal, fibrotic and microangiopathic damage Other: Evalution in healthy patients of bone mineral density, Klotho level and key bone-related cytokines

Study Design

Study Type:

Observational

Anticipated Enrollment :

126 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Mar 21, 2022

Anticipated Primary Completion Date :

Mar 21, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Systemic Sclerosis patients	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
Healthy subjects	Other: 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

Arm

Intervention/Treatment

Systemic Sclerosis patients

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

Healthy subjects

Other: 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

Outcome Measures

Primary Outcome Measures

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

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 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Rheumatology, Fondazione Policlinico Universitario A.Gemelli IRCCS	Rome	Lazio	Italy	00168

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mirone Luisa, Assistant Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT05777954

Other Study ID Numbers:

4633

First Posted:

Mar 21, 2023

Last Update Posted:

Mar 21, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Scleroderma, Systemic

Scleroderma, Diffuse

Sclerosis

Study Results

No Results Posted as of Mar 21, 2023