Clinical Trials Directory

Trials / Completed

CompletedNCT01567072

Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
192 (actual)
Sponsor
Marius Aliuskevicius · Academic / Other
Sex
All
Age
50 Years – 80 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGIbuprofenTreatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis
DRUGIbuprofenTreatment with Ibuprofen 600mg 3 times daily in 3 days after´diagnosis - Colles fracture
DRUGPlaceboOnly placebo treatment instead of NSAID painkillers

Timeline

Start date
2012-04-01
Primary completion
2016-06-01
Completion
2016-09-01
First posted
2012-03-30
Last updated
2016-09-07

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT01567072. Inclusion in this directory is not an endorsement.