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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03999528
• Other study ID #: Rheu-med.9med.research
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: August 1, 2019

Study information

• Verified date: June 2020
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoporosis
• Rheumatoid Arthritis

Intervention

Diagnostic Test:
• 14-3-3? Protein assay
blood sampling for assessment of serum 14-3-3? Protein

Locations

Country	Name	City	State
Egypt	Al-Azhar Faculty of medicine, Rheumatology Department	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	14-3-3? Protein and RA disease activity	percent of active RA disease and study the correlation between 14-3-3? Protein and RA disease activity	three months
Secondary	14-3-3? Protein and osteoporosis in RA patients	percent of low BMD and study the correlation between 14-3-3? Protein and osteoporosis in RA patients	three months