Prevalence of Subclinical Vertebral Fractures in Rheumatoid Arthritis and Ankylosing Spondylitis

October 16, 2023 updated by: BASMA ZARIEF NAGEH FAHMY, Assiut University

Prevalence of Subclinical Vertebral Fractures in Rheumatoid Arthritis and Ankylosing Spondylitis in Egyptian Patients and Its Relation to Some Clinical Data

Study of prevalence of subclinical vertebral fractures in Rheumatoid Arthritis and Ankylosing spondylitis

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Detection of the prevalence of subclinical vertebral fractures in Rheumatoid Arthritis and Ankylosing spondylitis Study the relation between vertebral fractures and some clinical data like demographics data, disease duration and disease severity

Study Type

Observational

Enrollment (Estimated)

93

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 Backup

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

RA patients Age from 25 to 45 AS patients age from 25 to 45 Healthy people age from 25 to 45

Description

Inclusion Criteria:

  • Patients fulfilling ACR/EULAR 2010 rheumatoid arthritis classification criteria.

Patients diagnosed as ankylosing spondylitis according to ASAS criteria (2000). Age (18-50).

Exclusion Criteria:

  • Patient with other autoimmune Rheumatic disease other than RA and AS. Infections including hepatitis C or B, HIV, tuberculosis. RA and AS patients with known vertebral fractures. Malignancy, hypogonadism, thyroid problems, chronic kidney disease, Hypoparathyroidism, Type 1 DM.

Pregnancy and breast-feeding.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RA group
DEXA scan X_rays lumber, dorsal spine
Device: DEXA scan,X_ray

DEXA scan detect osteoporosis

,X_ray show subclinical vertebral fractures
AS group
DEXA scan X_rays lumber, dorsal spine
Device: DEXA scan,X_ray

DEXA scan detect osteoporosis

,X_ray show subclinical vertebral fractures
Control group
DEXA scan X_rays lumber, dorsal spine
Device: DEXA scan,X_ray

DEXA scan detect osteoporosis

,X_ray show subclinical vertebral fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of prevalence of subclinical vertebral fractures in RA ,AS and control group
Time Frame: Baseline
Detection of prevalence of subclinical vertebral fractures in RA, AS and control group
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Doaa ABDELHAFEZ, Associte prof, yes
  • Study Director: REEM RAMADAN, Dr, yes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vertebral fractures RA ,AS

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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