Hip Fracture of Intertrochanteric TypeHSP 47NCT06959017
Diffrence in Thromboprofilaksis in Elderly Ostoepenic Hip Fractures According to Mobility Status by Genetic Analysis
A study testing Gene Expression Analysis in people with Hip Fracture of Intertrochanteric Type and Thromboembolic Event, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Hip fracture is a common and severe disease in elderly patients. The question of the study is whether elderly patients with severe osteopenia have significantly lower levels of the collagen-binding protein Hsp47 than relatively mobile patients due to advanced immobility before the fracture, and whether they… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Fracture of Intertrochanteric Type, Thromboembolic Event, Osteopenia
- What is being tested?
- Gene Expression Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- >65 years of age
- Interthrocanteric femur fracture AO Type 31A1, 31A2, 31A3
- Patients treated proksimal femoral nail
- Minor trauma
- Fracture mobility score 1,2,3,4,5
- Inial thrombocytes count 150.000-450.000 /µL
Who cannot join
- Body mass index >40
- Fracture mobility score 6 (unknown type)
- stage 4 chronic kidney disease
- Patients with rheumatological diseases
- Patients at serious risk of VTE(Venous thromboembolism) (according to the International Society on Thrombosis and Hemostasis, categorization of venous thromboembolism) :
- Active Hematologic Cancer
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- Antiphospholipid syndrome
- History of recurrent thrombosis (DVT)
- Paroxysmal nocturnal hemoglobinuria
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof Dr emil Tascıoglu City Hospital
Istanbul, Şişli, 34384
About this study
Official title: Is Thromboprotection Preserved in Elderly Ostopenic Patients Who Are Severly Immobilized Before Hip Fracture?
Hip fracture is a common and severe disease in elderly patients. The question of the study is whether elderly patients with severe osteopenia have significantly lower levels of the collagen-binding protein Hsp47 than relatively mobile patients due to advanced immobility before the fracture, and whether they participants have a similar risk of VTE to the normal population despite having had a hip fracture and surgery.
Read the detailed description
In this study, the investigators aimed to prospectively measure the Hsp 47 gene expression levels in patients scheduled for surgery due to intertrochanteric femur fracture and healthy volunteers in the same age group and compare the results with the literature.
Also the complications prior or after surgery will be compared.
- Conditions
- Hip Fracture of Intertrochanteric Type, Thromboembolic Event, Osteopenia, Thrombosis Embolism
- Being tested
- Gene Expression Analysis
- Keywords
- hip fracture, serpinh1, thromboembolism, rock1
- Medical subject headings
- Thromboembolism, Bone Diseases, Metabolic, Embolism and Thrombosis, Hip Fractures, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene Expression AnalysisGenetic
Each subject analysed for SERPİNH1 and ROCK1 gene exppression
| Study group | Role | What they receive |
|---|---|---|
| Sedentary | Active comparator | This group is consist of the patients with pre-fracture mobility score 3-4-5 Receives: Genetic: Gene Expression Analysis |
| Active | Experimental | This group is consist of the patients with pre-fracture mobility score 1-2 Receives: Genetic: Gene Expression Analysis |
| Control | Experimental | This group is consist of the volunteered healty people which >65 years of age Receives: Genetic: Gene Expression Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
HSP 47
HSP 47 (SERPİNH1, ROCK1) gene expression analysis
Measured: Gene expression analysis will be performed once samples are collected from all participants.
Secondary outcomes (1)
Thromboembolie
Thromboembolic events
Measured: from fracture occur up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 Nov 2024
- Primary completion1 Jun 2025
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip Fracture of Intertrochanteric TypeStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- All patients undergo genetic expression analysis of HSP 47 (SERPİNH1, ROCK1) and the also classified by their mobility score before fracture. There is also a control group consist of age appropied healty adults
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İsmail Demirkale, Saglik Bilimleri Universitesi
- Investigators
- İsmail Demirkale, Prof Dr, Study chair, Saglik Bilimleri Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959017
- Sponsor's protocol ID
- 01.04.2024-65
- Acronym
- HSP 47
- Status last verified
- Jun 2025
- First submitted
- 18 Apr 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thienel M, Muller-Reif JB, Zhang Z, Ehreiser V, Huth J, Shchurovska K, Kilani B, Schweizer L, Geyer PE, Zwiebel M, Novotny J, Lusebrink E, Little G, Orban M, Nicolai L, El Nemr S, Titova A, Spannagl M, Kindberg J, Evans AL, Mach O, Vogel M, Tiedt S, Ormanns S, Kessler B, Dueck A, Friebe A, Jorgensen PG, Majzoub-Altweck M, Blutke A, Polzin A, Stark K, Kaab S, Maier D, Gibbins JM, Limper U, Frobert O, Mann M, Massberg S, Petzold T. Immobility-associated thromboprotection is conserved across mammalian species from bear to human. Science. 2023 Apr 14;380(6641):178-187. doi: 10.1126/science.abo5044. Epub 2023 Apr 13.
PubMed 37053338
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Thromboprotection Preserved in Elderly Ostopenic Patients Who Are Severly Immobilized Before Hip Fracture?
- ClinicalTrials.gov ID
- NCT06959017
- Acronym / sponsor ID
- HSP 47 / 01.04.2024-65
- Conditions
- Hip Fracture of Intertrochanteric Type, Thromboembolic Event, Osteopenia, Thrombosis Embolism
- Keywords
- hip fracture, serpinh1, thromboembolism, rock1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 6 May 2025 (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.
Hip fracture is a common and severe disease in elderly patients. The question of the study is whether elderly patients with severe osteopenia have significantly lower levels of the collagen-binding protein Hsp47 than relatively mobile patients due to advanced immobility before the fracture, and whether they participants have a similar risk of VTE to the normal population despite having had a hip fracture and surgery.
Detailed description
In this study, the investigators aimed to prospectively measure the Hsp 47 gene expression levels in patients scheduled for surgery due to intertrochanteric femur fracture and healthy volunteers in the same age group and compare the results with the literature.
Also the complications prior or after surgery will be compared.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All patients undergo genetic expression analysis of HSP 47 (SERPİNH1, ROCK1) and the also classified by their mobility score before fracture. There is also a control group consist of age appropied healty adults
| Arm | Type | Receives |
|---|---|---|
| Sedentary | Active comparator | Genetic: Gene Expression AnalysisThis group is consist of the patients with pre-fracture mobility score 3-4-5 |
| Active | Experimental | Genetic: Gene Expression AnalysisThis group is consist of the patients with pre-fracture mobility score 1-2 |
| Control | Experimental | Genetic: Gene Expression AnalysisThis group is consist of the volunteered healty people which >65 years of age |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- >65 years of age
- Interthrocanteric femur fracture AO Type 31A1, 31A2, 31A3
- Patients treated proksimal femoral nail
- Minor trauma
- Fracture mobility score 1,2,3,4,5
Key exclusion criteria (9 listed)
- Body mass index >40
- Fracture mobility score 6 (unknown type)
- stage 4 chronic kidney disease
- Patients with rheumatological diseases
- Patients at serious risk of VTE(Venous thromboembolism) (according to the International Society on Thrombosis and Hemostasis, categorization of venous thromboembolism) :
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 |
|---|---|---|
| Gene Expression AnalysisEach subject analysed for SERPİNH1 and ROCK1 gene exppression | Genetic | Active, Control, Sedentary |
Primary outcome
HSP 47
Time frame: Gene expression analysis will be performed once samples are collected from all participants.
HSP 47 (SERPİNH1, ROCK1) gene expression analysis
1 secondary outcome
Thromboembolie
Time frame: from fracture occur up to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Background: PubMed 37053338Thienel M, Muller-Reif JB, Zhang Z, Ehreiser V, Huth J, Shchurovska K, Kilani B, Schweizer L, Geyer PE, Zwiebel M, Novotny J, Lusebrink E, Little G, Orban M, Nicolai L, El Nemr S, Titova A, Spannagl M, Kindberg J, Evans AL, Mach O, Vogel M, Tiedt S, Ormanns S, Kessler B, Dueck A, Friebe A, Jorgensen PG, Majzoub-Altweck M, Blutke A, Polzin A, Stark K, Kaab S, Maier D, Gibbins JM, Limper U, Frobert O, Mann M, Massberg S, Petzold T. Immobility-associated thromboprotection is conserved across mammalian species from bear to human. Science. 2023 Apr 14;380(6641):178-187. doi: 10.1126/science.abo5044. Epub 2023 Apr 13.
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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.
İsmail Demirkale, Prof Dr study chair
Saglik Bilimleri Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gene Expression Analysis in people with Hip Fracture of Intertrochanteric Type and Thromboembolic Event, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
HSP 47 (time frame: Gene expression analysis will be performed once samples are collected from all participants.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06959017, which also lists 1 linked publication.
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 5 Jun 2025.