Bone Intake Proteins and Muscle Mass Deficiency in Proximal Femur Fractures

Completed

• Conditions: Bone Loss; Bone Resorption; Muscle Loss; Muscle Damage; Femoral Neck Fractures; Pertrochanteric Fracture
• Interventions: Procedure: Blood sample test; Procedure: Surgical treatment of proximal femur fracture and blood sample test

• Registration Number: NCT05804604
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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

Not available

Study Timeline

• Study Start: 2022-05-07
• Primary Completion: 2022-11-29
• Study Completion: 2022-11-29
• Status Verified: 2023-03
• Study First Submitted: 2023-03-26
• Study First Submitted QC: 2023-03-26
• Study First Posted: 2023-04-07
• Last Update Submitted: 2023-07-29
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Level of bone intake proteins and muscle atrophy marker in patients without proximal femur fracture	Blood sample test	Control group without a history of proximal femur fracture. Analysis of the bone intake proteins and muscle atrophy marker serum level
Level of bone intake proteins and muscle atrophy marker in patients after proximal femur fracture	Surgical treatment of proximal femur fracture and blood sample test	Open reduction of femoral neck or pertrochanteric fracture and preoperative analysis of bone intake proteins and muscle atrophy marker serum concentration

Primary Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

Locations (1)

Department of Othopedics and Rehabilitation, Medical University of Warsaw; 🇵🇱 Warsaw, Poland