Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture (CHIP)

September 3, 2016 updated by: Marius Aliuskevicius

It is believed, that Non Steroidal Antiinflammatory Drug (NSAID) drugs slows bone healing, but the knowledge is based only on animal studies, and the results are automatically raised for the people.

Many patients with bone fracture must therefore avoid the formerly so popular and good painkillers, although no clinical trial evidence is, that this medicine is really harmful for patients with fractures.

The purpose of this study is to investigate whether these drugs slows bone healing, and what the relationship is between various bone studies - DEXA scanning, biochemical bone marker tests, radiographic controls and tissue examination of newly formed bone under a microscope. How sensitive and specific, each of the above study methods? If they are just as sensitive, the cheapest of them recommended as a routine investigation on suspicion of bone effects. Furthermore, to compare the benefit (pain-relieving effect, influence on rehabilitation) of these drugs and their possible harmful side effects (affected and delayed bone healing).

The expectation is that the study may contribute to increased knowledge about NSAIDs effect do pain management, rehabilitation and the entire treatment process significantly easier and safer, so that patients recover faster and return to usual activities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Department of Orthopaedic Surgery, Aalborg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written acceptance to participate in the study
  • immobilisation or reposition or surgery demanding Colles fracture (which needs to be fixed with external fixation).

Exclusion Criteria:

  • age - younger than 50 years or older than 80 years
  • treatment with prednisolon
  • NSAIDs - treatment
  • previous fracture or surgery at the wrist
  • lack of mental and physical capacity to follow studies' instructions
  • lack of informed consent
  • other diseases can affect bone substance (oncology, endocrine diseases)
  • medical contraindications to NSAIDs use
  • smoking, alcohol consumption of more than 14 drinks per week
  • secondary dislocation of fracture also apply as exclusion criterion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NSAIDs in 7 days
NSAIDs (Ibuprofen) in 7 days
Drug: Ibuprofen
Treatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis
Other Names:
  • M01AE01 7 days
Drug: Ibuprofen
Treatment with Ibuprofen 600mg 3 times daily in 3 days after´diagnosis - Colles fracture
Other Names:
  • M01AE01 3 days
Active Comparator: NSAIDs in 3 days
NSAIDs (Ibuprofen) in the first 3 days and placebo in the last 4 days
Drug: Ibuprofen
Treatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis
Other Names:
  • M01AE01 7 days
Drug: Ibuprofen
Treatment with Ibuprofen 600mg 3 times daily in 3 days after´diagnosis - Colles fracture
Other Names:
  • M01AE01 3 days
Placebo Comparator: Placebo
Only placebo in 7 days
Drug: Placebo
Only placebo treatment instead of NSAID painkillers
Other Names:
  • M01AE01 0 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of changes of fractures position by X rays investigation
Time Frame: 1 week, 2 weeks, 6 weeks
Measurement of possible secondary dislocation
1 week, 2 weeks, 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DEXA - scanning
Time Frame: 12 weeks
Evaluation of bone density
12 weeks
Bone Biochemical markers
Time Frame: 1 week, 2 weeks, 5 weeks, 3 months, 1 year
Se CrossLaps ELISA, N/Mid Osteocalcin Elisa
1 week, 2 weeks, 5 weeks, 3 months, 1 year
Histomorfometrical evaluation of bone biopsy from callus area
Time Frame: 6 weeks
qualitative evaluation of bone ossification
6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeated measurements of pain in 14 days
Time Frame: 2 weeks
subjective pain registration in 10 points scala 3 times dayly in 14 days
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marius Aliuskevicius

Collaborators

University of Aarhus

Investigators

  • Principal Investigator: Marius Aliuskevicius, Physician, Aalborg University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

March 20, 2012

First Submitted That Met QC Criteria

March 29, 2012

First Posted (Estimate)

March 30, 2012

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 3, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-018543-34

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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