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NCT Number: NCT05777954

Klotho and Mineral Bone Density in Systemic Sclerosis

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

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

45 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Division of Rheumatology, Fondazione Policlinico Universitario A.Gemelli IRCCS

Rome, Lazio, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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

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

    Time frame: 21 months

    Klotho serum levels in each SSc and control subject will be determined by a commercial ELISA assay

Secondary outcomes

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

    Time frame: 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).

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

    Time frame: 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

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

    Time frame: 21 months

    Assessment of a possible relationship among Klotho, DDK-1, OPG, and sclerostin serum levels

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 21, 2023
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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