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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Diagnostic test: DXA; Diagnostic test: serum sample; Diagnostic test: PROs

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37134
    • AOUI Verona - UOC Reumatologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

SLE patients 18-75 years

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of osteoporosis	percentage of patient with osteoporosis defined by WHO definition with T score	1 visit - 1 hour
Prevalence of fragility fractures	percentage of patients with fragility fractures	1 visit 1 hour
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)	1 visit - 1 hour
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)	1 visit - 1 hour
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)	1 visit - 1 hour
HADS	scores on mood disorder scale HADS (Health Anxiety and Depression Scale; min 0 - Max 42, higher score worse anxiety)	1 visit - 1 hour
PGA	Patient global assessment ( VAS scale 0-10) higher score worse health	1 visit - 1 hour
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)	1 visit - 1 hour
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.	1 visit - 1 hour
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	1 visit - 1 hour
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.	1 visit - 1 hour
CQR5	compliance questionnaire in rheumatology 5 items; adherent - not adherent to medication)	1 visit - 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 visit - 1 hour
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)	1 visit - 1 hour
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)	1 visit - 1 hour
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)	1 visit - 1 hour
serum bone biomarkers - BAP	bone alkaline phosphatase (BAP) (ug/L) level in study population and difference by fracture status	1 visit - 1 hour
serum bone biomarkers - P1NP	N-terminal propeptide of type I procollagen - P1NP (ng/ml) level in study population and difference by fracture status	1 visit - 1 hour
serum bone biomarkers - CTX	C-terminal telopeptide of type I collagen (CTX) (ng/ml), level in study population and difference by fracture status	1 visit - 1 hour
serum bone biomarkers - PTH	parathormone (PTH) pg/ml level in study population and difference by fracture status	1 visit - 1 hour
serum bone biomarkers - vitamin D(OH)	25OH vitamin D (ng/ml), level in study population and difference by fracture status	1 visit - 1 hour
serum bone biomarkers - Sclerostin	sclerostin (pmol/L) level in study population and difference by fracture status	1 visit - 1 hour
serum bone biomarkers - Dkk1	Dkk1 (pmol/L) level in study population and difference by fracture status	1 visit - 1 hour
serum bone biomarkers - RANKL	RANKL (pg/ml) level in study population and difference by fracture status	1 visit - 1 hour
serum bone biomarkers - OPG	OPG (pg/ml level) in study population and difference by fracture status	1 visit - 1 hour
Fracture risk calculation by FRAX tool	FRAX fracture risk assessment ( % risk major fracture in 10 yrs)	1 visit - 1 hour
Fracture risk calculation by DEFRA tool	DEFRA fracture risk assessment ( % risk major fracture in 10 yrs)	1 visit - 1 hour

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
• Investigators: Principal Investigator: Maurizio Rossini, MD, PhD, AOUI Verona - University of Verona

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2022
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Bone Diseases, Metabolic; Lupus Erythematosus, Systemic; Osteoporosis
• Other Study ID Numbers: 3875CESC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No