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Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture

NCT01567072 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2016-09-07

No results posted yet for this study

Summary

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.

Conditions

  • Forearm Fracture

Interventions

DRUG

Ibuprofen

Treatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis

DRUG

Ibuprofen

Treatment with Ibuprofen 600mg 3 times daily in 3 days after´diagnosis - Colles fracture

DRUG

Placebo

Only placebo treatment instead of NSAID painkillers

Sponsors & Collaborators

  • University of Aarhus

    collaborator OTHER

  • Marius Aliuskevicius

    lead OTHER

Principal Investigators

  • Marius Aliuskevicius, Physician · Aalborg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2016-06-30
Completion
2016-09-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01567072 on ClinicalTrials.gov