Bone Intake Proteins and Muscle Mass Deficiency in Proximal Femur Fractures

NCT ID: NCT05804604

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-07

Study Completion Date

2022-11-29

Brief Summary

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The aim of this clinical trial is to compare serum concentration of bone intake proteins \[ sex hormone-binding globulin (SHBG), cross linked C-telopeptide of type I collagen (CTX-I)\] and muscle atrophy marker \[creatine kinase (CK-MB)\] between patients after the fracture of proximal femur and their age corresponding counterpart without the fracture. The main question it aims to answer is:

• Is the higher concentration of bone intake proteins and muscle atrophy marker a predictive factor of proximal femur fracture?

The part of participants (Group 1) will be hospitalized at the Department of Orthopaedics and Rehabilitation and will undergo a surgical treatment (open reduction of the fracture). The rest (Group 2) will be admitted to the Department of Internal Medicine. Participants of both Groups will have the blood sample test taken, to evaluate and compare the serum concentration of SHBG, CTX-I and CK-MB proteins.

Detailed Description

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Conditions

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Femoral Neck Fractures Pertrochanteric Fracture Bone Resorption Bone Loss Muscle Loss Muscle Damage

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Level of bone intake proteins and muscle atrophy marker in patients after proximal femur fracture

Open reduction of femoral neck or pertrochanteric fracture and preoperative analysis of bone intake proteins and muscle atrophy marker serum concentration

Surgical treatment of proximal femur fracture and blood sample test

Intervention Type PROCEDURE

Open reduction of femoral neck or pertrochanteric fracture with hemi/total hip arthroplasty or gamma nail. Analysis of serum concentration of: SHBG, CTX - I, CK-MB

Level of bone intake proteins and muscle atrophy marker in patients without proximal femur fracture

Control group without a history of proximal femur fracture. Analysis of the bone intake proteins and muscle atrophy marker serum level

Blood sample test

Intervention Type PROCEDURE

Analysis of serum concentration of: SHBG, CTX - I, CK-MB

Interventions

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Surgical treatment of proximal femur fracture and blood sample test

Open reduction of femoral neck or pertrochanteric fracture with hemi/total hip arthroplasty or gamma nail. Analysis of serum concentration of: SHBG, CTX - I, CK-MB

Intervention Type PROCEDURE

Blood sample test

Analysis of serum concentration of: SHBG, CTX - I, CK-MB

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age over 65
* Proximal femur fracture (Group 1)

Exclusion Criteria

* neoplasmatic history in the anamnesis,
* prevalent fracture
* mental illness
* immune disease affecting protein balance
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Artur Stolarczyk

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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WarsawMU/FOPF

Identifier Type: -

Identifier Source: org_study_id

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