Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius 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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Aalborg, Denmark, 9000
- Department of Orthopaedic Surgery, Aalborg University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NSAIDs in 7 days
NSAIDs (Ibuprofen) in 7 days
|
Treatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis
Other Names:
Treatment with Ibuprofen 600mg 3 times daily in 3 days after´diagnosis - Colles fracture
Other Names:
|
|
Active Comparator: NSAIDs in 3 days
NSAIDs (Ibuprofen) in the first 3 days and placebo in the last 4 days
|
Treatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis
Other Names:
Treatment with Ibuprofen 600mg 3 times daily in 3 days after´diagnosis - Colles fracture
Other Names:
|
|
Placebo Comparator: Placebo
Only placebo in 7 days
|
Only placebo treatment instead of NSAID painkillers
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of changes of fractures position by X rays investigation
Time Frame: 1 week, 2 weeks, 6 weeks
|
Measurement of possible secondary dislocation
|
1 week, 2 weeks, 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DEXA - scanning
Time Frame: 12 weeks
|
Evaluation of bone density
|
12 weeks
|
|
Bone Biochemical markers
Time Frame: 1 week, 2 weeks, 5 weeks, 3 months, 1 year
|
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
Time Frame: 6 weeks
|
qualitative evaluation of bone ossification
|
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Repeated measurements of pain in 14 days
Time Frame: 2 weeks
|
subjective pain registration in 10 points scala 3 times dayly in 14 days
|
2 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marius Aliuskevicius, Physician, Aalborg University Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Arm Injuries
- Forearm Injuries
- Fractures, Bone
- Radius Fractures
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ibuprofen
Other Study ID Numbers
- 2010-018543-34
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