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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSAIDs in 7 days | Experimental | NSAIDs (Ibuprofen) in 7 days |
|
| NSAIDs in 3 days | Active Comparator | NSAIDs (Ibuprofen) in the first 3 days and placebo in the last 4 days |
|
| Placebo | Placebo Comparator | Only placebo in 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | Treatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Repeated measurements of pain in 14 days | subjective pain registration in 10 points scala 3 times dayly in 14 days | 2 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marius Aliuskevicius, Physician | Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopaedic Surgery, Aalborg University Hospital | Aalborg | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16470423 | Background | 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. |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Ibuprofen | Drug | Treatment with Ibuprofen 600mg 3 times daily in 3 days after´diagnosis - Colles fracture |
|
|
| Placebo | Drug | Only placebo treatment instead of NSAID painkillers |
|
|
| Histomorfometrical evaluation of bone biopsy from callus area | qualitative evaluation of bone ossification | 6 weeks |