Systemic SclerosisNCT05777954
Klotho and Mineral Bone Density in Systemic Sclerosis
An observational study of Systemic Sclerosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Possible Klotho effects on SSc clinical conditions, namely skeletal, fibrotic and microangiopathic damage and Evalution in healthy patients of bone mineral density, Klotho level and key bone-related cytokines
- How many people
- 126 participants
- Where
- 1 siteItaly
- Study dates
- 21 Mar 2022to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Female gender
- Systemic sclerosis diagnosis
- Signature of the informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Division of Rheumatology, Fondazione Policlinico Universitario A.Gemelli IRCCS
Rome, Lazio, 00168
About this study
Official title: Klotho and Bone Mineral Density (BMD) in Systemic Sclerosis Patients: Relationship with Microvascular Damage and Fibrosis
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
Read the 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.
- Conditions
- Systemic Sclerosis
- Being tested
- Possible Klotho effects on SSc clinical conditions, namely skeletal, fibrotic and microangiopathic damage, Evalution in healthy patients of bone mineral density, Klotho level and key bone-related cytokines
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Possible Klotho effects on SSc clinical conditions, namely skeletal, fibrotic and microangiopathic damageOther
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 cytokinesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Evalution in healthy patients of bone mineral density, Klotho level and key bone-related cytokines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 months
Secondary outcomes (3)
Klotho serum levels in female SSc patients: relationship to microvascular damage and fibrosis
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).
Measured: 21 months
Klotho serum levels in female SSc patients: relationship to bone mineral density values
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
Measured: 21 months
Klotho serum levels in female SSc patients relationship to key bone-related cytokine serum levels
Assessment of a possible relationship among Klotho, DDK-1, OPG, and sclerostin serum levels
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start21 Mar 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirone Luisa, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Luisa Mirone, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777954
- Sponsor's protocol ID
- 4633
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Klotho and Bone Mineral Density (BMD) in Systemic Sclerosis Patients: Relationship with Microvascular Damage and Fibrosis
- ClinicalTrials.gov ID
- NCT05777954
- Acronym / sponsor ID
- 4633
- Conditions
- Systemic Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic Sclerosis patients | – | Other: Possible Klotho effects on SSc clinical conditions, namely skeletal, fibrotic and microangiopathic damageFemale 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. |
| Healthy subjects | – | Other: Evalution in healthy patients of bone mineral density, Klotho level and key bone-related cytokinesFemale 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Female gender
- Systemic sclerosis diagnosis
- Signature of the informed consent
Key exclusion criteria (7 listed)
- Chronic kidney disease
- Liver or thyroid disease
- Diabetes
- Ongoing diuretic treatment
- Estrogen replacing treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Possible Klotho effects on SSc clinical conditions, namely skeletal, fibrotic and microangiopathic damageFemale 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 | Systemic Sclerosis patients |
| Evalution in healthy patients of bone mineral density, Klotho level and key bone-related cytokinesHealthy 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 | Other | Healthy subjects |
Primary outcome
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
3 secondary outcomes
Klotho serum levels in female SSc patients: relationship to microvascular damage and fibrosis
Time frame: 21 months
Klotho serum levels in female SSc patients: relationship to bone mineral density values
Time frame: 21 months
Klotho serum levels in female SSc patients relationship to key bone-related cytokine serum levels
Time frame: 21 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luisa Mirone principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.