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Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture (CHIP)

Primary Purpose

Forearm Fracture

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Ibuprofen
Ibuprofen
Placebo
Sponsored by
Marius Aliuskevicius
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Forearm Fracture focused on measuring NSAID, bone fracture, heal

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Orthopaedic Surgery, Aalborg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

NSAIDs in 7 days

NSAIDs in 3 days

Placebo

Arm Description

NSAIDs (Ibuprofen) in 7 days

NSAIDs (Ibuprofen) in the first 3 days and placebo in the last 4 days

Only placebo in 7 days

Outcomes

Primary Outcome Measures

Evaluation of changes of fractures position by X rays investigation
Measurement of possible secondary dislocation

Secondary Outcome Measures

DEXA - scanning
Evaluation of bone density
Bone Biochemical markers
Se CrossLaps ELISA, N/Mid Osteocalcin Elisa
Histomorfometrical evaluation of bone biopsy from callus area
qualitative evaluation of bone ossification

Full Information

First Posted
March 20, 2012
Last Updated
September 3, 2016
Sponsor
Marius Aliuskevicius
Collaborators
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01567072
Brief Title
Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture
Acronym
CHIP
Official Title
Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marius Aliuskevicius
Collaborators
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Forearm Fracture
Keywords
NSAID, bone fracture, heal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NSAIDs in 7 days
Arm Type
Experimental
Arm Description
NSAIDs (Ibuprofen) in 7 days
Arm Title
NSAIDs in 3 days
Arm Type
Active Comparator
Arm Description
NSAIDs (Ibuprofen) in the first 3 days and placebo in the last 4 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Only placebo in 7 days
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
M01AE01 7 days
Intervention Description
Treatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
M01AE01 3 days
Intervention Description
Treatment with Ibuprofen 600mg 3 times daily in 3 days after´diagnosis - Colles fracture
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
M01AE01 0 days
Intervention Description
Only placebo treatment instead of NSAID painkillers
Primary Outcome Measure Information:
Title
Evaluation of changes of fractures position by X rays investigation
Description
Measurement of possible secondary dislocation
Time Frame
1 week, 2 weeks, 6 weeks
Secondary Outcome Measure Information:
Title
DEXA - scanning
Description
Evaluation of bone density
Time Frame
12 weeks
Title
Bone Biochemical markers
Description
Se CrossLaps ELISA, N/Mid Osteocalcin Elisa
Time Frame
1 week, 2 weeks, 5 weeks, 3 months, 1 year
Title
Histomorfometrical evaluation of bone biopsy from callus area
Description
qualitative evaluation of bone ossification
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Repeated measurements of pain in 14 days
Description
subjective pain registration in 10 points scala 3 times dayly in 14 days
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius Aliuskevicius, Physician
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopaedic Surgery, Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
16470423
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.
Results Reference
background
Links:
URL
http://www.aalborgsygehus.rn.dk/Afdelinger/Hoved-+Orto-+Hjertecenter/Afdelinger/Ortopaedkirurgiske+afdelinger/For+fagfolk/OrtopaedkirurgiskForskningsenhed/
Description
Hospitals Unit for Research in Orthopaedics

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Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture

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