NCT01583660

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 24, 2012

Status Verified

April 1, 2012

Enrollment Period

1.9 years

First QC Date

February 13, 2012

Last Update Submit

April 21, 2012

Conditions

Keywords

NSAIDsAnti-inflammatoryelderly hip fracturemortality

Interventions

200mg, PO.Bid, last from admission to hospital to one week after operation.

Also known as: celebrex

1 tablet(Acetaminophen 325mg oxycodone 5mg), Q6h orally take,last from admission to hospital to one week after operation.

Also known as: Oxydodone and Acetaminophen Tablets

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • have autoimmune disease,
  • with blood disease, a history of thrombosis,
  • with sulfonamides, aspirin or celebrex race Levin allergies,
  • pathological fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Army General Hospital

Beijing, Beijing Municipality, 100700, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood serum

MeSH Terms

Conditions

Hip Fractures

Interventions

Celecoxiboxycodone-acetaminophenAcetaminophen

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesAnilidesAniline CompoundsAmines

Study Officials

  • Tiangsheng Sun, Prof.

    Beijing Army General Hospital

    STUDY CHAIR

Central Study Contacts

Shaoguang Li, Dr.

CONTACT

Tiangsheng Sun, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Li Shaoguang

Study Record Dates

First Submitted

February 13, 2012

First Posted

April 24, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2015

Last Updated

April 24, 2012

Record last verified: 2012-04

Locations