Bone Intake Proteins and Muscle Mass Deficiency in Proximal Femur Fractures

Study Overview
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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.

Official Title
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Serum Concentration of Bone Intake Proteins and Muscle Decay Markers as Risk Factors of Proximal Femur Fractures

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

Intervention / Treatment
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* Procedure: Surgical treatment of proximal femur fracture and blood sample test
* Procedure: Blood sample test


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Level of bone intake proteins and muscle atrophy marker in patients after proximal femur fracture<br>Open reduction of femoral neck or pertrochanteric fracture and preoperative analysis of bone intake proteins and muscle atrophy marker serum concentration | Procedure: Surgical treatment of proximal femur fracture and blood sample test<br>* 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<br>|
| Level of bone intake proteins and muscle atrophy marker in patients without proximal femur fracture<br>Control group without a history of proximal femur fracture. Analysis of the bone intake proteins and muscle atrophy marker serum level | Procedure: Blood sample test<br>* Analysis of serum concentration of: SHBG, CTX - I, CK-MB<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration of SHBG and comparison between intervention groups |  | (Group 1) At the day of the admission to the Department of Orthopaedics and Rehabilitation prior the surgical treatment or (Group 2) at the day of the admission to the Department of Internal Medicine | 
| Serum concentration of CTX-I and comparison between intervention groups |  | (Group 1) At the day of the admission to the Department of Orthopaedics and Rehabilitation prior the surgical treatment or (Group 2) at the day of the admission to the Department of Internal Medicine | 
| Serum concentration of CK-MB and comparison between intervention groups |  | (Group 1) At the day of the admission to the Department of Orthopaedics and Rehabilitation prior the surgical treatment or (Group 2) at the day of the admission to the Department of Internal Medicine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proximal femur fracture, femoral neck fracture, pertrochanteric fracture, bone intake proteins, bone resorption, bone loss, muscle damage, muscle loss