Clinical Research of the Prognostic Influence of NSAIDS's Anti-inflammatory Effect on Senior Patients With Hip Fracture

This study is currently recruiting participants.
Verified April 2012 by Beijing Army General Hospital
Sponsor:
Information provided by (Responsible Party):
Li Shaoguang, Beijing Army General Hospital
ClinicalTrials.gov Identifier:
NCT01583660
First received: February 13, 2012
Last updated: April 21, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Hip Fracture
Drug: celecoxib
Drug: Acetaminophen oxycodone

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Research of the Prognostic Influence of NSAIDS's Anti-inflammatory Effect on Senior Patients With Hip Fracture

Resource links provided by NLM:


Further study details as provided by Beijing Army General Hospital:

Biospecimen Retention:   Samples Without DNA

Peripheral blood serum


Estimated Enrollment: 800
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: celecoxib
    200mg, PO.Bid, last from admission to hospital to one week after operation.
    Other Name: celebrex
    Drug: Acetaminophen oxycodone
    1 tablet(Acetaminophen 325mg oxycodone 5mg), Q6h orally take,last from admission to hospital to one week after operation.
    Other Name: Oxydodone and Acetaminophen Tablets
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Elderly patients(age > 60 years old)with hip fracture(intertrochanteric fractures and femoral neck fractures)adimited into Beijing Army General Hospital

Criteria

Inclusion Criteria:

  • age > 60 years old,
  • new patients with hip fracture(intertrochanteric fractures and femoral neck fractures),
  • sign informed consent,
  • can be followed up

Exclusion Criteria:

  • have autoimmune disease,
  • with blood disease, a history of thrombosis,
  • with sulfonamides, aspirin or celebrex race Levin allergies,
  • pathological fracture
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583660

Contacts
Contact: Shaoguang Li, Dr. +86013488865818 13488865818@139.com
Contact: Tiangsheng Sun, Dr. +8601066721207 suntiansheng-@163.com

Locations
China, Beijing
Beijing Army General Hospital Recruiting
Beijing, Beijing, China, 100700
Contact: Shaoguang Li, Dr.    13488865818    13488865818@139.com   
Contact: Tiansheng Sun, Dr.    13501072165    suntiansheng-@163.com   
Principal Investigator: Shaoguang Li, Dr.         
Sponsors and Collaborators
Beijing Army General Hospital
Investigators
Study Chair: Tiangsheng Sun, Prof. Beijing Army General Hospital
  More Information

No publications provided

Responsible Party: Li Shaoguang, Beijing Army General Hospital
ClinicalTrials.gov Identifier: NCT01583660     History of Changes
Other Study ID Numbers: EC-KS-2011-026
Study First Received: February 13, 2012
Last Updated: April 21, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Army General Hospital:
NSAIDs
Anti-inflammatory
elderly hip fracture
mortality

Additional relevant MeSH terms:
Hip Fractures
Fractures, Bone
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Acetaminophen
Acetaminophen, hydrocodone drug combination
Celecoxib
Oxycodone
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antirheumatic Agents
Narcotics
Central Nervous System Depressants
Analgesics, Opioid
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014