Klotho and Mineral Bone Density in Systemic Sclerosis

NCT05777954 | Completed

• 1 other identifier: 4633
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Klotho serum levels in female SSc patients: relationship to microvascular damage and fibrosis

  21 months

• Klotho serum levels in female SSc patients: relationship to bone mineral density values

  21 months

• Klotho serum levels in female SSc patients relationship to key bone-related cytokine serum levels

  21 months

Study Arms (2)

Systemic Sclerosis patients

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.

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

Healthy subjects

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.

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

Interventions

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

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

Systemic Sclerosis patients

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

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

Healthy subjects

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients with a diagnosis of Systemic Sclerosis according to the EULAR/ACR 2013 criteria and followed by the FPG-IRCSS Rheumatology Department will be progressively recruited, after exclusion criteria are ruled out and informed consent is signed. Concomitantly healthy control female patients undergoing bone mineral density determination are recruited, once exclusion criteria are ruled out.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Division of Rheumatology, Fondazione Policlinico Universitario A.Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

two blood samples to dose DKK-1, sclerostin, Osteoprotegerin and Klotho

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Luisa Mirone

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 21, 2023
• Study Start: March 21, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)