Clinical trial NCT05804604: Bone Intake Proteins and Muscle Mass Deficiency in Proximal Femur Fractures
Official title: Serum Concentration of Bone Intake Proteins and Muscle Decay Markers as Risk Factors of Proximal Femur Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Neck Fractures
Pertrochanteric Fracture
Bone Resorption
Bone Loss
Muscle Loss
Muscle Damage
Keywords: proximal femur fracture
femoral neck fracture
pertrochanteric fracture
bone intake proteins
bone resorption
bone loss
muscle damage
muscle loss
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the Department of Orthopaedics and Rehabilitation (due to proximal femur fracture) or to the Department of Internal Medicine (due to exacerbation of chronic disease process). The citizens of Warsaw in age over 65 who meet inclusion criteria.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serum concentration of SHBG and comparison between intervention groups
timeFrame: (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
measure: Serum concentration of CTX-I and comparison between intervention groups
timeFrame: (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
measure: Serum concentration of CK-MB and comparison between intervention groups
timeFrame: (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
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Othopedics and Rehabilitation, Medical University of Warsaw
Study officials:
References: