Clinical trial NCT05777954: Klotho and Mineral Bone Density in Systemic Sclerosis
Official title: Klotho and Bone Mineral Density (BMD) in Systemic Sclerosis Patients: Relationship with Microvascular Damage and Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Sclerosis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 126
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: 21 months
Secondary outcomes:
measure: Klotho serum levels in female SSc patients: relationship to microvascular damage and fibrosis
timeFrame: 21 months
measure: Klotho serum levels in female SSc patients: relationship to bone mineral density values
timeFrame: 21 months
measure: Klotho serum levels in female SSc patients relationship to key bone-related cytokine serum levels
timeFrame: 21 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Division of Rheumatology, Fondazione Policlinico Universitario A.Gemelli IRCCS
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Luisa Mirone
role: PRINCIPAL_INVESTIGATOR
References: