Skip to main content
OpenTrials
Completed

NCT Number: NCT01567072

Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Orthopaedic Surgery, Aalborg University Hospital

Aalborg, 9000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ibuprofen

Drug

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

Other names: M01AE01 7 days

Placebo

Drug

Only placebo treatment instead of NSAID painkillers

Other names: M01AE01 0 days

Primary outcomes

  1. Evaluation of changes of fractures position by X rays investigation

    Time frame: 1 week, 2 weeks, 6 weeks

    Measurement of possible secondary dislocation

Secondary outcomes

  1. DEXA - scanning

    Time frame: 12 weeks

    Evaluation of bone density

  2. Bone Biochemical markers

    Time frame: 1 week, 2 weeks, 5 weeks, 3 months, 1 year

    Se CrossLaps ELISA, N/Mid Osteocalcin Elisa

  3. Histomorfometrical evaluation of bone biopsy from callus area

    Time frame: 6 weeks

    qualitative evaluation of bone ossification

Other outcomes

  1. Repeated measurements of pain in 14 days

    Time frame: 2 weeks

    subjective pain registration in 10 points scala 3 times dayly in 14 days

Sponsors and collaborators

Lead sponsor

Marius Aliuskevicius

Other

Collaborators

  • University of Aarhus

Registry information

Acronym: CHIP

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 30, 2012
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.