NCT05777954Completed
Klotho and Mineral Bone Density in Systemic Sclerosis
Klotho and Bone Mineral Density (BMD) in Systemic Sclerosis Patients: Relationship with Microvascular Damage and Fibrosis
Source: ClinicalTrials.gov · Last updated 12 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 126 (actual)
- First submitted
- 21 Feb 2023
- Start date
- 21 Mar 2022
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT05777954
What you commit to
- Study type: Observational
- Participants enrolled: 126
- From 21 Mar 2022 to the primary completion date, 30 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Drugs able to interfere with bone turn-over (such as bisphosphonates or glucocorticoids)
Other illness
- Chronic kidney disease
- Liver or thyroid disease
- Diabetes
Lab values
- Vitamin D or Calcium supplementation
Other
- Ongoing diuretic treatment
- Estrogen replacing treatment
Who the study is looking for
- Female gender
- Systemic sclerosis diagnosis
- Signature of the informed consent
Age in the registry: 45 years to 65 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Rheumatology, Fondazione Policlinico Universitario A.Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.