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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05804604
Enrollment
40
Registered
2023-04-07
Start date
2022-05-07
Completion date
2022-11-29
Last updated
2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

PROCEDURESurgical 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

Analysis of serum concentration of: SHBG, CTX - I, CK-MB

Sponsors

Medical University of Warsaw
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

Design outcomes

Primary

MeasureTime 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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026