AzTrials
AzTrials

Lupus Erythematosus, SystemicFRAILNCT05590390

Osteoporosis and Fragility Fractures Among SLE Patients. (FRAIL Trial)

An observational study of Lupus Erythematosus, Systemic, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The trial is designed to evaluate prevalence of fragility fracture, their impact on quality of life of SLE patients and disease or treatment variables such as steroids dosage or use of specific drugs like hydroxychloroquine, DMARDs or belimumab. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lupus Erythematosus, Systemic
What is being tested?
DXA, serum sample and PROs
How many people
300 participants
Where
1 siteItaly
Study dates
31 Dec 2022to 30 Dec 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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: SLE patients 18-75 years

Who may be able to join

  • SLE fulfilling 2019 ACR/EULAR or 2012 SLICC criteria
  • willing to perform DXA/ x-Ray investigation (common clinical practice)
  • willing to donate blood sample
  • willing to complete questionnaires
  • the patients should be in a stable disease activity.

Who cannot join

  • Uncontrolled endocrinological disease.
  • metabolic bone disease other than osteoporosis ( e.g. Paget disease).
  • celiac disease, inflammatory bowel disease or pancreatic exocrine deficiency resulting in malabsorption
  • patients lacking medication history information (SLE and bone related medications).
  • Have any other clinically significant abnormal laboratory value in the opinion of the investigator
  • Have any intercurrent significant medical illness that the investigator considers would make the candidate unsuitable for the study.
  • The patients shouldn't be enrolled during a moderate to severe flare of disease requiring an escalation of therapy ( especially glucocorticoid) - no new BILAG A or B in the last 3 months.
  • Pregnant patients or during the first year after child birth.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • AOUI Verona - UOC Reumatologia

    Verona, 37134

Other trials in Italy

About this study

Official title: Prevalence and Impact on Quality of Life of Osteoporosis and Fragility Fractures Among SLE Patients. (FRAIL Trial)

The trial is designed to evaluate prevalence of fragility fracture, their impact on quality of life of SLE patients and disease or treatment variables such as steroids dosage or use of specific drugs like hydroxychloroquine, DMARDs or belimumab. Patients will perform DXA evaluation, blood tests and PROs questionnaires. Moreover, the investigators want to correlate those variables to bone turnover markers and bone metabolism modulators. A secondary aim is also to assess the fracture risk of those patients as described by FRAX and DEFRA tools.

Being tested
DXA, serum sample, PROs
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DXADiagnostic test

    bone densitometry at lumbar and femoral site+ morphometry (DXA),

  • serum sampleDiagnostic test

    serum samples for bone biomarkers ( eg. P1NP, CTX, Dkk-1, etc)

  • PROsDiagnostic test

    questionnaires to investigate patients reported outcome on quality of life

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of osteoporosis

    percentage of patient with osteoporosis defined by WHO definition with T score

    Measured: 1 visit - 1 hour

  2. Prevalence of fragility fractures

    percentage of patients with fragility fractures

    Measured: 1 visit 1 hour

  3. EQ5D

    scores at questionnaire on quality of life EQ5D = EuroQol 5 dimension 5 L; (min 1-1-1-1-1, max 5-5-5-5-5 higher score worse + EQ VAS min 0, max 100 higher score better quality of life)

    Measured: 1 visit - 1 hour

  4. FACIT-F

    scores in fatigue as for questionnaire FACIT-F (Functional Assessment of Chronic Illness Therapy - Fatigue; min 0 - max 52, higher score less fatigue)

    Measured: 1 visit - 1 hour

  5. SF-36 v2

    scores on quality of life with SF36 v2 (Short Form 36 version 2 Health Survey; min 0 - max 100, higher score better health)

    Measured: 1 visit - 1 hour

  6. HADS

    scores on mood disorder scale HADS (Health Anxiety and Depression Scale; min 0 - Max 42, higher score worse anxiety)

    Measured: 1 visit - 1 hour

  7. CQR5

    compliance questionnaire in rheumatology 5 items; adherent - not adherent to medication)

    Measured: 1 visit - 1 hour

  8. PGA

    Patient global assessment ( VAS scale 0-10) higher score worse health

    Measured: 1 visit - 1 hour

  9. influence of SLE medication - glucocorticoid

    The population will be analyzed grouping by presence or absence of fragility fracture in relation to medications variables such as difference in cumulative corticosteroid dose (mg)

    Measured: 1 visit - 1 hour

  10. influence of SLE medication - hydroxychloroquine

    The population will be analyzed grouping by presence or absence of fragility fracture in relation to medications variables such as difference in percentage of hydroxychloroquine users.

    Measured: 1 visit - 1 hour

  11. influence of SLE medication - immunosuppressant

    The population will be analyzed grouping by presence or absence of fragility fracture in relation to medications variables such as difference in percentage percentage of immunosuppressant users

    Measured: 1 visit - 1 hour

  12. influence of SLE medication - biologics

    The population will be analyzed grouping by presence or absence of fragility fracture in relation to medications variables such as difference in percentage of percentage of biologics ( e.g. belimumab) users.

    Measured: 1 visit - 1 hour

Secondary outcomes (15)

  1. Descriptive statistics of study population - 1

    The population will be analyzed as whole and also grouping by presence or absence of fragility fracture in relation to clinical variables - SLE disease duration

    Measured: 1 visit - 1 hour

  2. Descriptive statistics of study population - 2

    The population will be analyzed as whole and also grouping by presence or absence of fragility fracture in relation to clinical variables - SDI ( SLICC Damage index - from 0, higher score higher disease damage accrual)

    Measured: 1 visit - 1 hour

  3. Descriptive statistics of study population - 3

    The population will be analyzed as whole and also grouping by presence or absence of fragility fracture in relation to demographic variable - Age ( years)

    Measured: 1 visit - 1 hour

  4. Descriptive statistics of study population - 4

    The population will be analyzed as whole and also grouping by presence or absence of fragility fracture in relation to demographic variable - gender ( % females)

    Measured: 1 visit - 1 hour

  5. serum bone biomarkers - BAP

    bone alkaline phosphatase (BAP) (ug/L) level in study population and difference by fracture status

    Measured: 1 visit - 1 hour

  6. serum bone biomarkers - P1NP

    N-terminal propeptide of type I procollagen - P1NP (ng/ml) level in study population and difference by fracture status

    Measured: 1 visit - 1 hour

  7. serum bone biomarkers - CTX

    C-terminal telopeptide of type I collagen (CTX) (ng/ml), level in study population and difference by fracture status

    Measured: 1 visit - 1 hour

  8. serum bone biomarkers - PTH

    parathormone (PTH) pg/ml level in study population and difference by fracture status

    Measured: 1 visit - 1 hour

  9. serum bone biomarkers - vitamin D(OH)

    25OH vitamin D (ng/ml), level in study population and difference by fracture status

    Measured: 1 visit - 1 hour

  10. serum bone biomarkers - Sclerostin

    sclerostin (pmol/L) level in study population and difference by fracture status

    Measured: 1 visit - 1 hour

  11. serum bone biomarkers - Dkk1

    Dkk1 (pmol/L) level in study population and difference by fracture status

    Measured: 1 visit - 1 hour

  12. serum bone biomarkers - RANKL

    RANKL (pg/ml) level in study population and difference by fracture status

    Measured: 1 visit - 1 hour

  13. serum bone biomarkers - OPG

    OPG (pg/ml level) in study population and difference by fracture status

    Measured: 1 visit - 1 hour

  14. Fracture risk calculation by FRAX tool

    FRAX fracture risk assessment ( % risk major fracture in 10 yrs)

    Measured: 1 visit - 1 hour

  15. Fracture risk calculation by DEFRA tool

    DEFRA fracture risk assessment ( % risk major fracture in 10 yrs)

    Measured: 1 visit - 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2022
  2. Study start31 Dec 2022
  3. Primary completion30 Oct 2024 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

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
Cohort
Time perspective
Cross-sectional
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05590390
Sponsor's protocol ID
3875CESC
Acronym
FRAIL
Status last verified
Aug 2024
First submitted
7 Oct 2022
Last updated
6 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rotta D, Adami G, Galvagni I, Pistillo F, Fassio A, Gatti D, Zen M, Ravagnani V, Maiolini F, Croce J, Volpe A, Dartizio C, Benini C, Ruzzon F, Viapiana O, Rossini M, Orsolini G. Prevalence and determinants of vertebral fractures in a SLE cohort. Lupus Sci Med. 2025 Sep 14;12(2):e001508. doi: 10.1136/lupus-2025-001508.

    PubMed 40953912

Questions about this trial

What is this clinical trial studying?

An observational study of Lupus Erythematosus, Systemic, run by Azienda Ospedaliera Universitaria Integrata Verona 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. 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?

Results are not available in the source record.

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?

Prevalence of osteoporosis (time frame: 1 visit - 1 hour). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05590390, which also lists 1 linked publication.

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 6 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in