NCT01567072

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

4.2 years

First QC Date

March 20, 2012

Last Update Submit

September 3, 2016

Conditions

Forearm Fracture

Keywords

NSAIDbone fractureheal

Outcome Measures

Primary Outcomes (1)

  • Evaluation of changes of fractures position by X rays investigation

    Measurement of possible secondary dislocation

    1 week, 2 weeks, 6 weeks

Secondary Outcomes (3)

  • DEXA - scanning

    12 weeks

  • Bone Biochemical markers

    1 week, 2 weeks, 5 weeks, 3 months, 1 year

  • Histomorfometrical evaluation of bone biopsy from callus area

    6 weeks

Other Outcomes (1)

  • Repeated measurements of pain in 14 days

    2 weeks

Study Arms (3)

NSAIDs in 7 days

EXPERIMENTAL

NSAIDs (Ibuprofen) in 7 days

Drug: Ibuprofen

NSAIDs in 3 days

ACTIVE COMPARATOR

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

Drug: Ibuprofen

Placebo

PLACEBO COMPARATOR

Only placebo in 7 days

Drug: Placebo

Interventions

IbuprofenDRUG

Treatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis

Also known as: M01AE01 7 days
NSAIDs in 7 days
PlaceboDRUG

Only placebo treatment instead of NSAID painkillers

Also known as: M01AE01 0 days
Placebo

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written acceptance to participate in the study
  • immobilisation or reposition or surgery demanding Colles fracture (which needs to be fixed with external fixation).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedic Surgery, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Related 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. doi: 10.1080/17453670510045309.

    PMID: 16470423BACKGROUND

MeSH Terms

Conditions

Fractures, Bone

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Marius Aliuskevicius, Physician

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 20, 2012

First Posted

March 30, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations

DK(1)