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NCT Number: NCT05590390

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AOUI Verona - UOC Reumatologia

Verona, 37134, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

DXA

Diagnostic Test

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

serum sample

Diagnostic Test

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

PROs

Diagnostic Test

questionnaires to investigate patients reported outcome on quality of life

Primary outcomes

  1. Prevalence of osteoporosis

    Time frame: 1 visit - 1 hour

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

  2. Prevalence of fragility fractures

    Time frame: 1 visit 1 hour

    percentage of patients with fragility fractures

  3. EQ5D

    Time frame: 1 visit - 1 hour

    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)

  4. FACIT-F

    Time frame: 1 visit - 1 hour

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

  5. SF-36 v2

    Time frame: 1 visit - 1 hour

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

  6. HADS

    Time frame: 1 visit - 1 hour

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

  7. CQR5

    Time frame: 1 visit - 1 hour

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

  8. PGA

    Time frame: 1 visit - 1 hour

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

  9. influence of SLE medication - glucocorticoid

    Time frame: 1 visit - 1 hour

    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)

  10. influence of SLE medication - hydroxychloroquine

    Time frame: 1 visit - 1 hour

    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.

  11. influence of SLE medication - immunosuppressant

    Time frame: 1 visit - 1 hour

    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

  12. influence of SLE medication - biologics

    Time frame: 1 visit - 1 hour

    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.

Secondary outcomes

  1. Descriptive statistics of study population - 1

    Time frame: 1 visit - 1 hour

    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

  2. Descriptive statistics of study population - 2

    Time frame: 1 visit - 1 hour

    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)

  3. Descriptive statistics of study population - 3

    Time frame: 1 visit - 1 hour

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

  4. Descriptive statistics of study population - 4

    Time frame: 1 visit - 1 hour

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

  5. serum bone biomarkers - BAP

    Time frame: 1 visit - 1 hour

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

  6. serum bone biomarkers - P1NP

    Time frame: 1 visit - 1 hour

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

  7. serum bone biomarkers - CTX

    Time frame: 1 visit - 1 hour

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

  8. serum bone biomarkers - PTH

    Time frame: 1 visit - 1 hour

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

  9. serum bone biomarkers - vitamin D(OH)

    Time frame: 1 visit - 1 hour

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

  10. serum bone biomarkers - Sclerostin

    Time frame: 1 visit - 1 hour

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

  11. serum bone biomarkers - Dkk1

    Time frame: 1 visit - 1 hour

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

  12. serum bone biomarkers - RANKL

    Time frame: 1 visit - 1 hour

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

  13. serum bone biomarkers - OPG

    Time frame: 1 visit - 1 hour

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

  14. Fracture risk calculation by FRAX tool

    Time frame: 1 visit - 1 hour

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

  15. Fracture risk calculation by DEFRA tool

    Time frame: 1 visit - 1 hour

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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

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

Acronym: FRAIL

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 21, 2022
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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