Bone Intake Proteins and Muscle Mass Deficiency in Proximal Femur Fractures

• Sponsor: Medical University of Warsaw (Other)
• Overall Status: Completed
• CT.gov ID: NCT05804604
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Actual Duration (Months): 6.8
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

The aim of this clinical trial is to compare serum concentration of bone intake proteins (SHBG, CTX-I) and muscle atrophy marker (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.

Condition or Disease	Intervention/Treatment	Phase
Femoral Neck Fractures; Pertrochanteric Fracture; Bone Resorption; Bone Loss; Muscle Loss; Muscle Damage	Procedure: Surgical treatment of proximal femur fracture and blood sample test; Procedure: Blood sample test

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Serum Concentration of Bone Intake Proteins and Muscle Decay Markers as Risk Factors of Proximal Femur Fractures
• Actual Study Start Date: May 7, 2022
• Actual Primary Completion Date: Nov 29, 2022
• Actual Study Completion Date: Nov 29, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Othopedics and Rehabilitation, Medical University of Warsaw	Warsaw		Poland	03-984

Sponsors and Collaborators

• Medical University of Warsaw

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Warsaw
• ClinicalTrials.gov Identifier: NCT05804604
• Other Study ID Numbers: WarsawMU/FOPF
• First Posted: Apr 7, 2023
• Last Update Posted: Apr 7, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Medical University of Warsaw: proximal femur fracture; femoral neck fracture; pertrochanteric fracture; bone intake proteins; bone resorption; bone loss; muscle damage; muscle loss
• Additional relevant MeSH terms: Bone Resorption; Fractures, Bone; Femoral Neck Fractures; Femoral Fractures

Study Results

No Results Posted as of Apr 7, 2023