Bone Intake Proteins and Muscle Mass Deficiency in Proximal Femur Fractures

NCT05804604 | Completed

• 1 other identifier: WarsawMU/FOPF
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

proximal femur fracture; femoral neck fracture; pertrochanteric fracture; bone intake proteins; bone resorption; bone loss; muscle damage; muscle loss

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

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

Interventions

Surgical treatment of proximal femur fracture and blood sample test 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 after proximal femur fracture

Blood sample test PROCEDURE

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• neoplasmatic history in the anamnesis,
• prevalent fracture
• mental illness
• immune disease affecting protein balance

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, 04-749, Poland

Location

MeSH Terms

Conditions

Femoral Neck Fractures; Bone Resorption; Bone Diseases, Metabolic; Muscular Atrophy; Proximal Femoral Fractures

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 7, 2023
• Study Start: May 7, 2022
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-03

Locations

PL (1)