14-3-3η Protein, Disease Activity and Bone Mineral Densit... | NCT03999528

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

NCT03999528

Sponsor

Al-Azhar University

Status

Completed

Last Update Posted

Jun 9, 2020Actual

Enrollment

45Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis
Osteoporosis

Interventions

14-3-3η Protein assay

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Aug 1, 2019Actual

Completion Date

Aug 1, 2019Actual

First Submitted Date

Jun 10, 2019

First Submission Date that Met QC Criteria

Jun 25, 2019

First Posted Date

Jun 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2020

Last Update Posted Date

Jun 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group		RA Patients	Diagnostic Test: 14-3-3η Protein assay
control group		normal control	Diagnostic Test: 14-3-3η Protein assay

Interventions

Name	Type	Description	Arm Group Labels	Other Names
14-3-3η Protein assay	Diagnostic Test	blood sampling for assessment of serum 14-3-3η Protein	control group study group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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,

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AHMED ABOGAMAL	Al-Azhar Faculty of medicine- Cairo	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-Azhar Faculty of medicine, Rheumatology Department		Cairo		11311	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided