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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05804604
Other study ID # WarsawMU/FOPF
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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