Bone Intake Proteins and Muscle Mass Deficiency in Proximal Femur Fractures

Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05804604
• Other study ID #: WarsawMU/FOPF
• Status: Completed
• Start date: May 7, 2022
• Est. completion date: November 29, 2022

Study information

• Verified date: March 2023
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 29, 2022
• Est. primary completion date: November 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• Blood sample test
Analysis of serum concentration of: SHBG, CTX - I, CK-MB

Locations

Country	Name	City	State
Poland	Department of Othopedics and Rehabilitation, Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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