Clinical trial NCT01567072: Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture
Official title: Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Forearm Fracture
Keywords: NSAID
bone fracture
heal
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2012-03-30
Enrollment: 192
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of changes of fractures position by X rays investigation
timeFrame: 1 week, 2 weeks, 6 weeks
Secondary outcomes:
measure: DEXA - scanning
timeFrame: 12 weeks
measure: Bone Biochemical markers
timeFrame: 1 week, 2 weeks, 5 weeks, 3 months, 1 year
measure: Histomorfometrical evaluation of bone biopsy from callus area
timeFrame: 6 weeks
Other outcomes:
measure: Repeated measurements of pain in 14 days
timeFrame: 2 weeks
Locations:
city: Aalborg
country: Denmark
facility: Department of Orthopaedic Surgery, Aalborg University Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Marius Aliuskevicius, Physician
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.