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NCT Number: NCT03999528

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Bone Diseases, Metabolic Connective Tissue Diseases Immune System Diseases Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Al-Azhar Faculty of medicine, Rheumatology Department

Cairo, 11311, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

14-3-3η Protein assay

Diagnostic Test

blood sampling for assessment of serum 14-3-3η Protein

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 26, 2019
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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