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Prevalence of Subclinical Vertebral Fractures in Rheumatoid Arthritis and Ankylosing Spondylitis

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06092775
Collaborator
(none)
93
Enrollment
13
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: DEXA scan,X_ray

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 Design

Study Type:
Observational
Anticipated Enrollment :
93 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prevalence of Subclinical Vertebral Fractures in Rheumatoid Arthritis and Ankylosing Spondylitis in Egyptian Patients and Its Relation to Some Clinical Data
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Comparison of prevalence of subclinical vertebral fractures in RA ,AS and control group [Baseline]

    Detection of prevalence of subclinical vertebral fractures in RA, AS and control group

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
BASMA ZARIEF NAGEH FAHMY, Resident doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT06092775
Other Study ID Numbers:
  • Vertebral fractures RA ,AS
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Fractures, Bone
Spinal Fractures

Study Results

No Results Posted as of Oct 23, 2023