Klotho and Mineral Bone Density in Systemic Sclerosis

CompletedOBSERVATIONAL
Enrollment

126

Participants

Timeline

Start Date

March 21, 2022

Primary Completion Date

April 30, 2024

Study Completion Date

April 30, 2024

Conditions
Systemic Sclerosis
Interventions
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"

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

Trial Locations (1)

00168

Division of Rheumatology, Fondazione Policlinico Universitario A.Gemelli IRCCS, Rome

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER