Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture

Study Overview
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Brief Summary
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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.

Official Title
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Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture

Conditions
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Forearm Fracture

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Ibuprofen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DEXA - scanning | Evaluation of bone density | 12 weeks | 
| Bone Biochemical markers | 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 | qualitative evaluation of bone ossification | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSAID, bone fracture, heal