Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture

Phase 3

Completed

• Conditions: Forearm Fracture
• Interventions: Drug: Ibuprofen; Drug: Placebo

• Registration Number: NCT01567072
• Lead Sponsor: Marius Aliuskevicius

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-29
• Study First Posted: 2012-03-30
• Study Start: 2012-04
• Primary Completion: 2016-06
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-03
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSAIDs in 3 days	Ibuprofen	NSAIDs (Ibuprofen) in the first 3 days and placebo in the last 4 days
Placebo	Placebo	Only placebo in 7 days
NSAIDs in 7 days	Ibuprofen	NSAIDs (Ibuprofen) in 7 days

Primary Outcome Measures

Name	Time	Method
Evaluation of changes of fractures position by X rays investigation	1 week, 2 weeks, 6 weeks	Measurement of possible secondary dislocation

Secondary Outcome Measures

Name	Time	Method
Bone Biochemical markers	1 week, 2 weeks, 5 weeks, 3 months, 1 year	Se CrossLaps ELISA, N/Mid Osteocalcin Elisa
Histomorfometrical evaluation of bone biopsy from callus area	6 weeks	qualitative evaluation of bone ossification
DEXA - scanning	12 weeks	Evaluation of bone density

Trial Locations

Locations (1)

Department of Orthopaedic Surgery, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark