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OpenTrials
Completed

NCT Number: NCT05804604

Bone Intake Proteins and Muscle Mass Deficiency in Proximal Femur Fractures

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.

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Key information

Conditions

Femoral Neck Fractures Atrophy Bone Diseases Bone Diseases, Metabolic Bone Loss Bone Resorption Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Metabolic Diseases Muscle Damage Muscle Loss Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pertrochanteric Fracture Proximal Femoral Fractures Signs and Symptoms Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, 04-749, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Blood sample test

Procedure

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

Primary outcomes

  1. Serum concentration of SHBG and comparison between intervention groups

    Time frame: (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

    Time frame: (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

    Time frame: (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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 7, 2023
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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