Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture

Forearm Fracture Clinical Trial

— CHIP  

Official title:

Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01567072
• Other study ID #: 2010-018543-34
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2012
• Last updated: September 3, 2016
• Start date: April 2012
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Forearm Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Denmark	Department of Orthopaedic Surgery, Aalborg University Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Marius Aliuskevicius	University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Repeated measurements of pain in 14 days	subjective pain registration in 10 points scala 3 times dayly in 14 days	2 weeks	Yes
Primary	Evaluation of changes of fractures position by X rays investigation	Measurement of possible secondary dislocation	1 week, 2 weeks, 6 weeks	Yes
Secondary	DEXA - scanning	Evaluation of bone density	12 weeks	Yes
Secondary	Bone Biochemical markers	Se CrossLaps ELISA, N/Mid Osteocalcin Elisa	1 week, 2 weeks, 5 weeks, 3 months, 1 year	Yes
Secondary	Histomorfometrical evaluation of bone biopsy from callus area	qualitative evaluation of bone ossification	6 weeks	Yes

External Links

•   Hospitals Unit for Research in Orthopaedics