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

Lupus Erythematosus, Systemic Clinical Trial

— FRAIL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05590390
• Other study ID #: 3875CESC
• Status: Recruiting
• Start date: December 31, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2022
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: Giovanni Orsolini, MD, PhD
• Phone: +390458128035
• Email: giovanni.orsolini[@]aovr.veneto.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Osteoporosis

Intervention

Diagnostic Test:
• DXA
bone densitometry at lumbar and femoral site+ morphometry (DXA),
• serum sample
serum samples for bone biomarkers ( eg. P1NP, CTX, Dkk-1, etc)
• PROs
questionnaires to investigate patients reported outcome on quality of life

Locations

Country	Name	City	State
Italy	AOUI Verona - UOC Reumatologia	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of osteoporosis	percentage of patient with osteoporosis defined by WHO definition with T score	1 visit - 1 hour
Primary	Prevalence of fragility fractures	percentage of patients with fragility fractures	1 visit 1 hour
Primary	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
Primary	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
Primary	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
Primary	HADS	scores on mood disorder scale HADS (Health Anxiety and Depression Scale; min 0 - Max 42, higher score worse anxiety)	1 visit - 1 hour
Primary	CQR5	compliance questionnaire in rheumatoogy 5 items; adherent - not adherent to medication)	1 visit - 1 hour
Primary	PGA	Patient global assessment ( VAS scale 0-10) higher score worse health	1 visit - 1 hour
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	serum bone biomarkers - BAP	bone alkaline phosphatase (BAP) (ug/L) level in study population and difference by fracture status	1 visit - 1 hour
Secondary	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
Secondary	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
Secondary	serum bone biomarkers - PTH	parathormone (PTH) pg/ml level in study population and difference by fracture status	1 visit - 1 hour
Secondary	serum bone biomarkers - vitamin D(OH)	25OH vitamin D (ng/ml), level in study population and difference by fracture status	1 visit - 1 hour
Secondary	serum bone biomarkers - Sclerostin	sclerostin (pmol/L) level in study population and difference by fracture status	1 visit - 1 hour
Secondary	serum bone biomarkers - Dkk1	Dkk1 (pmol/L) level in study population and difference by fracture status	1 visit - 1 hour
Secondary	serum bone biomarkers - RANKL	RANKL (pg/ml) level in study population and difference by fracture status	1 visit - 1 hour
Secondary	serum bone biomarkers - OPG	OPG (pg/ml level) in study population and difference by fracture status	1 visit - 1 hour
Secondary	Fracture risk calculation by FRAX tool	FRAX fracture risk assessment ( % risk major fracture in 10 yrs)	1 visit - 1 hour
Secondary	Fracture risk calculation by DEFRA tool	DEFRA fracture risk assessment ( % risk major fracture in 10 yrs)	1 visit - 1 hour