Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture
NCT ID: NCT01567072
Last Updated: 2016-09-07
Study Results
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Basic Information
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COMPLETED
PHASE3
192 participants
INTERVENTIONAL
2012-04-30
2016-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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NSAIDs in 7 days
NSAIDs (Ibuprofen) in 7 days
Ibuprofen
Treatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis
NSAIDs in 3 days
NSAIDs (Ibuprofen) in the first 3 days and placebo in the last 4 days
Ibuprofen
Treatment with Ibuprofen 600mg 3 times daily in 3 days after´diagnosis - Colles fracture
Placebo
Only placebo in 7 days
Placebo
Only placebo treatment instead of NSAID painkillers
Interventions
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Ibuprofen
Treatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis
Ibuprofen
Treatment with Ibuprofen 600mg 3 times daily in 3 days after´diagnosis - Colles fracture
Placebo
Only placebo treatment instead of NSAID painkillers
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* immobilisation or reposition or surgery demanding Colles fracture (which needs to be fixed with external fixation).
Exclusion Criteria
* 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.
50 Years
80 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Marius Aliuskevicius
OTHER
Responsible Party
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Marius Aliuskevicius
Principal Investigator
Principal Investigators
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Marius Aliuskevicius, Physician
Role: PRINCIPAL_INVESTIGATOR
Aalborg University Hospital
Locations
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Department of Orthopaedic Surgery, Aalborg University Hospital
Aalborg, , Denmark
Countries
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References
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Persson PE, Nilsson OS, Berggren AM. Do non-steroidal anti-inflammatory drugs cause endoprosthetic loosening? A 10-year follow-up of a randomized trial on ibuprofen for prevention of heterotopic ossification after hip arthroplasty. Acta Orthop. 2005 Dec;76(6):735-40. doi: 10.1080/17453670510045309.
Other Identifiers
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2010-018543-34
Identifier Type: -
Identifier Source: org_study_id
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