Femoral Neck FracturesNCT05804604
Bone Intake Proteins and Muscle Mass Deficiency in Proximal Femur Fractures
An observational study of Femoral Neck Fractures and Pertrochanteric Fracture, run by Medical University of Warsaw at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Femoral Neck Fractures, Pertrochanteric Fracture, Bone Resorption
- What is being tested?
- Surgical treatment of proximal femur fracture and blood sample test and Blood sample test
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 7 May 2022to 29 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- Age over 65
- Proximal femur fracture (Group 1)
Who cannot join
- neoplasmatic history in the anamnesis,
- prevalent fracture
- mental illness
- immune disease affecting protein balance
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Othopedics and Rehabilitation, Medical University of Warsaw
Warsaw, 04-749
About this study
Official title: Serum Concentration of Bone Intake Proteins and Muscle Decay Markers as Risk Factors of 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.
- Conditions
- Femoral Neck Fractures, Pertrochanteric Fracture, Bone Resorption, Bone Loss, Muscle Loss, Muscle Damage
- Being tested
- Surgical treatment of proximal femur fracture and blood sample test, Blood sample test
- Keywords
- proximal femur fracture, femoral neck fracture, pertrochanteric fracture, bone intake proteins, bone resorption, bone loss, muscle damage, muscle loss
- Medical subject headings
- Femoral Neck Fractures, Bone Resorption, Bone Diseases, Metabolic, Muscular Atrophy, Proximal Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatment of proximal femur fracture and blood sample testProcedure or surgery
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 testProcedure or surgery
Analysis of serum concentration of: SHBG, CTX - I, CK-MB
| Study group | Role | What they receive |
|---|---|---|
| Level of bone intake proteins and muscle atrophy marker in patients after proximal femur fracture | Open reduction of femoral neck or pertrochanteric fracture and preoperative analysis of bone intake proteins and muscle atrophy marker serum concentration Receives: Procedure: Surgical treatment of proximal femur fracture and blood sample test | |
| Level of bone intake proteins and muscle atrophy marker in patients without proximal femur fracture | Control group without a history of proximal femur fracture. Analysis of the bone intake proteins and muscle atrophy marker serum level Receives: Procedure: Blood sample test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of SHBG and comparison between intervention groups
Measured: (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
Measured: (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
Measured: (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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start7 May 2022
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Artur Stolarczyk, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804604
- Sponsor's protocol ID
- WarsawMU/FOPF
- Status last verified
- Mar 2023
- First submitted
- 26 Mar 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Concentration of Bone Intake Proteins and Muscle Decay Markers as Risk Factors of Proximal Femur Fractures
- ClinicalTrials.gov ID
- NCT05804604
- Acronym / sponsor ID
- WarsawMU/FOPF
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 7 May 2022 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Level of bone intake proteins and muscle atrophy marker in patients after proximal femur fracture | – | Procedure: Surgical treatment of proximal femur fracture and blood sample testOpen reduction of femoral neck or pertrochanteric fracture and preoperative analysis of bone intake proteins and muscle atrophy marker serum concentration |
| Level of bone intake proteins and muscle atrophy marker in patients without proximal femur fracture | – | Procedure: Blood sample testControl group without a history of proximal femur fracture. Analysis of the bone intake proteins and muscle atrophy marker serum level |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (2 listed)
- Age over 65
- Proximal femur fracture (Group 1)
Key exclusion criteria (4 listed)
- neoplasmatic history in the anamnesis,
- prevalent fracture
- mental illness
- immune disease affecting protein balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical treatment of proximal femur fracture and blood sample testOpen 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 | Procedure or surgery | Level of bone intake proteins and muscle atrophy marker in patients after proximal femur fracture |
| Blood sample testAnalysis of serum concentration of: SHBG, CTX - I, CK-MB | Procedure or surgery | Level of bone intake proteins and muscle atrophy marker in patients without proximal femur fracture |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Neck Fractures and Pertrochanteric Fracture, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.