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

August 5, 2024 updated by: Azienda Ospedaliera Universitaria Integrata Verona

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of osteoporosis
Time Frame: 1 visit - 1 hour
percentage of patient with osteoporosis defined by WHO definition with T score
1 visit - 1 hour
Prevalence of fragility fractures
Time Frame: 1 visit 1 hour
percentage of patients with fragility fractures
1 visit 1 hour
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)
1 visit - 1 hour
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)
1 visit - 1 hour
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)
1 visit - 1 hour
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)
1 visit - 1 hour
PGA
Time Frame: 1 visit - 1 hour
Patient global assessment ( VAS scale 0-10) higher score worse health
1 visit - 1 hour
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)
1 visit - 1 hour
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.
1 visit - 1 hour
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
1 visit - 1 hour
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.
1 visit - 1 hour
CQR5
Time Frame: 1 visit - 1 hour
compliance questionnaire in rheumatology 5 items; adherent - not adherent to medication)
1 visit - 1 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
1 visit - 1 hour
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)
1 visit - 1 hour
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)
1 visit - 1 hour
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)
1 visit - 1 hour
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
1 visit - 1 hour
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
1 visit - 1 hour
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
1 visit - 1 hour
serum bone biomarkers - PTH
Time Frame: 1 visit - 1 hour
parathormone (PTH) pg/ml level in study population and difference by fracture status
1 visit - 1 hour
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
1 visit - 1 hour
serum bone biomarkers - Sclerostin
Time Frame: 1 visit - 1 hour
sclerostin (pmol/L) level in study population and difference by fracture status
1 visit - 1 hour
serum bone biomarkers - Dkk1
Time Frame: 1 visit - 1 hour
Dkk1 (pmol/L) level in study population and difference by fracture status
1 visit - 1 hour
serum bone biomarkers - RANKL
Time Frame: 1 visit - 1 hour
RANKL (pg/ml) level in study population and difference by fracture status
1 visit - 1 hour
serum bone biomarkers - OPG
Time Frame: 1 visit - 1 hour
OPG (pg/ml level) in study population and difference by fracture status
1 visit - 1 hour
Fracture risk calculation by FRAX tool
Time Frame: 1 visit - 1 hour
FRAX fracture risk assessment ( % risk major fracture in 10 yrs)
1 visit - 1 hour
Fracture risk calculation by DEFRA tool
Time Frame: 1 visit - 1 hour
DEFRA fracture risk assessment ( % risk major fracture in 10 yrs)
1 visit - 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Ospedaliera Universitaria Integrata Verona

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maurizio Rossini, MD, PhD, AOUI Verona - University of Verona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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