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

June 7, 2020 updated by: Ahmed Abogamal, Al-Azhar University
Is to investigate the relation between 14-3-3η protein, disease activity, and bone mineral density in female patients with rheumatoid arthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

45

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt, 11311
        • Al-Azhar Faculty of medicine, Rheumatology Department

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

patients with rheumatoid arthritis attending the Rheumatology department, at Al-Azhar faculty of medicine from May 2019 to August 2019

Description

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 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
study group
RA Patients
Diagnostic test: 14-3-3η Protein assay
blood sampling for assessment of serum 14-3-3η Protein
control group
normal control
Diagnostic test: 14-3-3η Protein assay
blood sampling for assessment of serum 14-3-3η Protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
14-3-3η Protein and RA disease activity
Time Frame: three months
percent of active RA disease and study the correlation between 14-3-3η Protein and RA disease activity
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
14-3-3η Protein and osteoporosis in RA patients
Time Frame: three months
percent of low BMD and study the correlation between 14-3-3η Protein and osteoporosis in RA patients
three months

Collaborators and Investigators

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

Sponsor

Al-Azhar University

Investigators

  • Study Chair: AHMED ABOGAMAL, Al-Azhar Faculty of medicine- Cairo

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)

May 1, 2019

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

June 10, 2019

First Submitted That Met QC Criteria

June 25, 2019

First Posted (Actual)

June 26, 2019

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 7, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rheu-med.9med.research

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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