14-3-3η Protein, Disease Activity and Bone Mineral Density, in Female Patients With Rheumatoid Arthritis

Completed

• Conditions: Osteoporosis; Rheumatoid Arthritis
• Interventions: Diagnostic Test: 14-3-3η Protein assay

• Registration Number: NCT03999528
• Lead Sponsor: Al-Azhar University

Brief Summary

Is to investigate the relation between 14-3-3η protein, disease activity, and bone mineral density in female patients with rheumatoid arthritis.

Detailed Description

Methods: all patients in the study will subject to:

* Clinical assessment, WT, Height ,BMI, parity, medications,

* DAS 28.

* Serum 14-3-3η protein.

* DEXA scan.

Grouping:

* Group I: RA Patients with low BMD.

* Group II: RA Patients with normal BMD.

* Group III: normal control.

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-26
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-07
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

• Rheumatoid arthritis according to ACR 2010 criteria with at least one year duration.
• Premenopausal females.
• On conventional DMARD with maximum 5 mg steroids.

Exclusion Criteria

• Biological treatment.
• Previous antiresorptive treatment, or bone anabolics.
• High dose corticosteroid.
• Chronic renal or kidney disease.
• Medications affecting bone metabolism.
• Thyroid or adrenal dysfunction,

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	14-3-3η Protein assay	normal control
study group	14-3-3η Protein assay	RA Patients

Primary Outcome Measures

Name	Time	Method
14-3-3η Protein and RA disease activity	three months	percent of active RA disease and study the correlation between 14-3-3η Protein and RA disease activity

Secondary Outcome Measures

Name	Time	Method
14-3-3η Protein and osteoporosis in RA patients	three months	percent of low BMD and study the correlation between 14-3-3η Protein and osteoporosis in RA patients

Trial Locations

Locations (1)

Al-Azhar Faculty of medicine, Rheumatology Department; 🇪🇬 Cairo, Egypt