Non Steroidal Antiinflammatory Drugs Influence on Heal of Colles Fracture (CHIP)
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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
- Evaluation of changes of fractures position by X rays investigation [ Time Frame: 1 week, 2 weeks, 6 weeks ] [ Designated as safety issue: Yes ]Measurement of possible secondary dislocation
- Evaluation of changes in value of biochemical bone markers [ Time Frame: 1 week, 2 weeks, 6 weeks, 12 weeks, 52 weeks. ] [ Designated as safety issue: Yes ]Helps to evaluate process of bone resorbtion and formation
- DEXA - scanning [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Evaluation of bone density
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: NSAIDs in 7 days
NSAIDs (Ibuprofen) in 7 days
Treatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis
Active Comparator: NSAIDs in 3 days
NSAIDs (Ibuprofen) in the first 3 days and placebo in the last 4 days
Treatment with Ibuprofen 600mg 3 times daily in 3 days after´diagnosis - Colles fracture
Placebo Comparator: Placebo
Only placebo in 7 days
Only placebo treatment instead of NSAID painkillers
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567072
|Contact: Marius Aliuskevicius, Master of Medicin||+45 firstname.lastname@example.org|
|Contact: Jane Dorthea Livoni||+45 email@example.com|
|Department of Orthopaedic Surgery, Aalborg University Hospital||Recruiting|
|Aalborg, Denmark, 9000|
|Contact: Marius Aliuskevicius, Master of Medicine +45 99325195 firstname.lastname@example.org|
|Principal Investigator: Marius Aliuskevicius, Master of Medicine|