Bone Intake Proteins and Muscle Mass Deficiency in Proximal Femur Fractures

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 04-749
    • Department of Othopedics and Rehabilitation, Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients admitted to the Department of Orthopaedics and Rehabilitation (due to proximal femur fracture) or to the Department of Internal Medicine (due to exacerbation of chronic disease process). The citizens of Warsaw in age over 65 who meet inclusion criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: 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
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	Procedure: Blood sample test; Analysis of serum concentration of: SHBG, CTX - I, CK-MB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2022
• Primary Completion (Actual): November 29, 2022
• Study Completion (Actual): November 29, 2022

Study Registration Dates

• First Submitted: March 26, 2023
• First Submitted That Met QC Criteria: March 26, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: pertrochanteric fracture; femoral neck fracture; bone loss; bone resorption; muscle loss; muscle damage; proximal femur fracture; bone intake proteins
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Musculoskeletal Diseases; Bone Diseases; Hip Injuries; Hip Fractures; Femoral Fractures; Fractures, Bone; Femoral Neck Fractures; Bone Resorption
• Other Study ID Numbers: WarsawMU/FOPF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No