Hip FractureNCT01583660
Clinical Research of the Prognostic Influence of NSAIDS's Anti-inflammatory Effect on Senior Patients With Hip Fracture
An observational study of Hip Fracture, run by Beijing Army General Hospital at 1 site in China.
Trial summary
With the development of society, aged population is growing. Hip fracture is the most common disease for aged people. With the life being longer than before, incidence of this disease is growing. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- celecoxib and Acetaminophen oxycodone
- Type of treatment
- Pill or oral medicine
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2015
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly patients(age > 60 years old)with hip fracture(intertrochanteric fractures and femoral neck fractures)adimited into Beijing Army General Hospital
Who may be able to join
- age > 60 years old,
- new patients with hip fracture(intertrochanteric fractures and femoral neck fractures),
- sign informed consent,
- can be followed up
Who cannot join
- have autoimmune disease,
- with blood disease, a history of thrombosis,
- with sulfonamides, aspirin or celebrex race Levin allergies,
- pathological fracture
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Army General Hospital
Beijing, Beijing Municipality, 100700
Shaoguang Li, Dr., 13488865818, 13488865818@139.com
Tiansheng Sun, Dr., 13501072165, suntiansheng-@163.com
About this study
With the development of society, aged population is growing. Hip fracture is the most common disease for aged people. With the life being longer than before, incidence of this disease is growing. The mortality of this disease is high-- almost 10% patients will die within 1 month, about 1/3 of patients will die within 12 months. About 20%-30% aged people who have hip fracture will die within one year.
The damaged organs caused by excessive inflammatory is one of possible reasons to cause higher mortality. Therefore, the investigators imagined that if they gave medicines to patients in time to reduce the inflammatory level, the inflammatory might have less effects on organs, and the recovery could be improved.
The investigators hypothesis on the basic research: the anti-inflammatory function of non steroidal antiinflammatory drugs (NSAIDs) can inhibit the inflammatory level of elderly hip fracture, so as to improve the recovery level and reduce the complicating disease and mortality. The investigators designed a clinic study to research NSAIDS' effects on inflammatory level and prognosis of elderly hip fracture.
Read the detailed description
With the development of society, aged population is growing. The number of the aged people over 60 years old now reaches to 130 million. Hip fracture is the most common disease for aged people. According to Britain's statistical data of hip fracture, the average age of males who have hip fracture is 84 years old, and female, 83 years old, and female patients account for 74% of all the reported cases. The disease is deadly-- when attacked almost 10% patients die within 1 month, about 1/3 of patients die within 12 months. When seniors are attacked by hip fracture, about 20%-30% die within one year, 25% recover to normal life before the attack, and 55% patients become disabled in different degrees. Senile fracture has become an important issue relating to public health, brought huge burdens to average families. While developing very fast, our modern society has to come up with a solution to this urgent scientific problem.
The study has shown that the increasing inflammatory cytokines after senile fracture are independent dangerous factors of death and complications and the systemic inflammatory response after senile fracture causes organ damage and may explain why the seniors attacked by hip fracture are more likely to die than their peers. Therefore, we intend to give drug therapy to patients in the early stage after the attack, to reduce the inflammatory response of the body, thus reducing the damage of the body by the inflammatory response, and improving the prognosis of patients.
By inhibiting cyclooxygenase COX, and in turn the arachidonic acid (AA)'s transformation into prostaglandians (PGs) and thromboxane TXA, NSAIDs produces anti-inflammatory, antipyretic, analgesic and anti-rheumatism actions. It has been widely applied in clinic. According to study, there are two cyclooxygenase insomers in human body namely COX-1 and COX-2. COX-1, which exists in normal tissues, with physiological stimulation, can stimulate arachidonic acid to produce thromboxane A, prostaglandin e (PGE2) and prostacyclin I2 (PGI2). It can therefore protect the gastrointestinal tract, kidney, platelets, and vascular endothelial cells, and is also called structural enzyme. COX-2 is a type of COX induced by cytokines and produced under inflammatory stimulation, COX-2 mediates arachidonic acid to produce PGE-2 and PGI-2. As inflammatory prostaglandin, COX-2 has inflammation-causing effects and pain-causing effects. Its inhibition lays the pharmacological foundation for the antipyretic, analgesic, and anti-inflammatory effects of NSAIDs
Some animal experiment has showed that the inhibitor of COX-2 reduces the inflammatory expression of animal models after multiple severe traumas and enhances the survival rate. Recent reports suggest that the inhibitor of COX-2 (parecoxib) can reduce pro inflammatory cytokines after traumas, chemokine level and relieve acute lung injury. Clinic study shows that if applying the inhibitor of COX-2 into arthroplasty, the level of systemic inflammatory cytokines can be reduced, and a better postoperative function realized. There has been no report about the treatment of inflammatory response by NSAID after severe trauma.
In clinic, pain treatment has been conventional in modern wards and become a symbol of modern wards. In the newly published British NICE clinical guidelines of hip fracture, pain treatment of patients with hip fracture is pointed out as an appropriate method. Sufficient pain-treating enables patients to take part in necessary activities, and undergo medical examination, nursing care and rehabilitation. N-acethy aminophenol (paracetamol) is recommended. In case that the alone application of N-acethy aminophenol cannot completely relieve the pain, opiate drugs should be added. The guideline does not recommend NSAIDS since it may induce gastrointestinal complication. However, since it overcomes the side effect of gastrointestinal reaction, NSAIDS as a fundamental drug in pain treatment, especially an inhibitor of COX-2 has been widely applied in the treatment of trauma pain. But its anti-inflammatory effect has not been paid enough attention. Based on the above findings and research foundations, we wonder that besides its analgesic effect, whether NSAIDS has a equally beneficial anti-inflammatory effect on the excessive inflammatory response patient with severe trauma, and senior patients with hip fracture and improve their prognosis. Therefore, based on the fundamental research, we assume that the anti-inflammatory effect of NSAIDs can relieve the systemic inflammatory effect of senior patients with hip fracture, improve their prognosis, reduce incidence of complications and deaths. Through a prospective clinical experiment, we plan to study the effect of NSAIDS on the changes of inflammatory factors of senior patients with hip fracture, and their prognosis.
- Conditions
- Hip Fracture
- Being tested
- celecoxib, Acetaminophen oxycodone
- Keywords
- NSAIDs, Anti-inflammatory, elderly hip fracture, mortality
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
Also called celebrex
200mg, PO.Bid, last from admission to hospital to one week after operation.
Acetaminophen oxycodoneDrug
Also called Oxydodone and Acetaminophen Tablets
1 tablet(Acetaminophen 325mg oxycodone 5mg), Q6h orally take,last from admission to hospital to one week after operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Army General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Li Shaoguang, Beijing Army General Hospital
- Investigators
- Tiangsheng Sun, Prof., Study chair, Beijing Army General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583660
- Sponsor's protocol ID
- EC-KS-2011-026
- Status last verified
- Apr 2012
- First submitted
- 13 Feb 2012
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research of the Prognostic Influence of NSAIDS's Anti-inflammatory Effect on Senior Patients With Hip Fracture
- ClinicalTrials.gov ID
- NCT01583660
- Acronym / sponsor ID
- EC-KS-2011-026
- Conditions
- Hip Fracture
- Keywords
- NSAIDs, Anti-inflammatory, elderly hip fracture, mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Beijing Army General HospitalOther government
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 Apr 2012 (estimated)
- 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.
With the development of society, aged population is growing. Hip fracture is the most common disease for aged people. With the life being longer than before, incidence of this disease is growing. The mortality of this disease is high-- almost 10% patients will die within 1 month, about 1/3 of patients will die within 12 months. About 20%-30% aged people who have hip fracture will die within one year.
The damaged organs caused by excessive inflammatory is one of possible reasons to cause higher mortality. Therefore, the investigators imagined that if they gave medicines to patients in time to reduce the inflammatory level, the inflammatory might have less effects on organs, and the recovery could be improved.
The investigators hypothesis on the basic research: the anti-inflammatory function of non steroidal antiinflammatory drugs (NSAIDs) can inhibit the inflammatory level of elderly hip fracture, so as to improve the recovery level and reduce the complicating disease and mortality. The investigators designed a clinic study to research NSAIDS' effects on inflammatory level and prognosis of elderly hip fracture.
Detailed description
With the development of society, aged population is growing. The number of the aged people over 60 years old now reaches to 130 million. Hip fracture is the most common disease for aged people. According to Britain's statistical data of hip fracture, the average age of males who have hip fracture is 84 years old, and female, 83 years old, and female patients account for 74% of all the reported cases. The disease is deadly-- when attacked almost 10% patients die within 1 month, about 1/3 of patients die within 12 months. When seniors are attacked by hip fracture, about 20%-30% die within one year, 25% recover to normal life before the attack, and 55% patients become disabled in different degrees. Senile fracture has become an important issue relating to public health, brought huge burdens to average families. While developing very fast, our modern society has to come up with a solution to this urgent scientific problem.
The study has shown that the increasing inflammatory cytokines after senile fracture are independent dangerous factors of death and complications and the systemic inflammatory response after senile fracture causes organ damage and may explain why the seniors attacked by hip fracture are more likely to die than their peers. Therefore, we intend to give drug therapy to patients in the early stage after the attack, to reduce the inflammatory response of the body, thus reducing the damage of the body by the inflammatory response, and improving the prognosis of patients.
By inhibiting cyclooxygenase COX, and in turn the arachidonic acid (AA)'s transformation into prostaglandians (PGs) and thromboxane TXA, NSAIDs produces anti-inflammatory, antipyretic, analgesic and anti-rheumatism actions. It has been widely applied in clinic. According to study, there are two cyclooxygenase insomers in human body namely COX-1 and COX-2. COX-1, which exists in normal tissues, with physiological stimulation, can stimulate arachidonic acid to produce thromboxane A, prostaglandin e (PGE2) and prostacyclin I2 (PGI2). It can therefore protect the gastrointestinal tract, kidney, platelets, and vascular endothelial cells, and is also called structural enzyme. COX-2 is a type of COX induced by cytokines and produced under inflammatory stimulation, COX-2 mediates arachidonic acid to produce PGE-2 and PGI-2. As inflammatory prostaglandin, COX-2 has inflammation-causing effects and pain-causing effects. Its inhibition lays the pharmacological foundation for the antipyretic, analgesic, and anti-inflammatory effects of NSAIDs
Some animal experiment has showed that the inhibitor of COX-2 reduces the inflammatory expression of animal models after multiple severe traumas and enhances the survival rate. Recent reports suggest that the inhibitor of COX-2 (parecoxib) can reduce pro inflammatory cytokines after traumas, chemokine level and relieve acute lung injury. Clinic study shows that if applying the inhibitor of COX-2 into arthroplasty, the level of systemic inflammatory cytokines can be reduced, and a better postoperative function realized. There has been no report about the treatment of inflammatory response by NSAID after severe trauma.
In clinic, pain treatment has been conventional in modern wards and become a symbol of modern wards. In the newly published British NICE clinical guidelines of hip fracture, pain treatment of patients with hip fracture is pointed out as an appropriate method. Sufficient pain-treating enables patients to take part in necessary activities, and undergo medical examination, nursing care and rehabilitation. N-acethy aminophenol (paracetamol) is recommended. In case that the alone application of N-acethy aminophenol cannot completely relieve the pain, opiate drugs should be added. The guideline does not recommend NSAIDS since it may induce gastrointestinal complication. However, since it overcomes the side effect of gastrointestinal reaction, NSAIDS as a fundamental drug in pain treatment, especially an inhibitor of COX-2 has been widely applied in the treatment of trauma pain. But its anti-inflammatory effect has not been paid enough attention. Based on the above findings and research foundations, we wonder that besides its analgesic effect, whether NSAIDS has a equally beneficial anti-inflammatory effect on the excessive inflammatory response patient with severe trauma, and senior patients with hip fracture and improve their prognosis. Therefore, based on the fundamental research, we assume that the anti-inflammatory effect of NSAIDs can relieve the systemic inflammatory effect of senior patients with hip fracture, improve their prognosis, reduce incidence of complications and deaths. Through a prospective clinical experiment, we plan to study the effect of NSAIDS on the changes of inflammatory factors of senior patients with hip fracture, and their prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly patients(age > 60 years old)with hip fracture(intertrochanteric fractures and femoral neck fractures)adimited into Beijing Army General Hospital
Key inclusion criteria (4 listed)
- age > 60 years old,
- new patients with hip fracture(intertrochanteric fractures and femoral neck fractures),
- sign informed consent,
- can be followed up
Key exclusion criteria (4 listed)
- have autoimmune disease,
- with blood disease, a history of thrombosis,
- with sulfonamides, aspirin or celebrex race Levin allergies,
- pathological fracture
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 |
|---|---|---|
| celecoxibAlso: celebrex200mg, PO.Bid, last from admission to hospital to one week after operation. | Drug | – |
| Acetaminophen oxycodoneAlso: Oxydodone and Acetaminophen Tablets1 tablet(Acetaminophen 325mg oxycodone 5mg), Q6h orally take,last from admission to hospital to one week after operation. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
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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.
Tiangsheng Sun, Prof. study chair
Beijing Army General Hospital
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 Hip Fracture, run by Beijing Army General Hospital at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 24 Apr 2012. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaoguang Li, Dr. (+86013488865818, 13488865818@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 24 Apr 2012.