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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Shaoguang Li, Dr. contact

+86013488865818

13488865818@139.com

Tiangsheng Sun, Dr. contact

+8601066721207

suntiansheng-@163.com

China1 site, 1 recruiting
  • Beijing Army General Hospital

    Beijing, Beijing Municipality, 100700

    Shaoguang Li, Dr., 13488865818, 13488865818@139.com

    Tiansheng Sun, Dr., 13501072165, suntiansheng-@163.com

    Recruiting

Other trials in China

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.

  1. First posted24 Apr 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2013 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

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)
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

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.

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