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

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ClinicalTrials.gov Identifier: NCT01567072
Recruitment Status : Completed
First Posted : March 30, 2012
Last Update Posted : September 7, 2016
University of Aarhus
Information provided by (Responsible Party):
Marius Aliuskevicius, Aalborg Universitetshospital

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.

Condition or disease Intervention/treatment Phase
Forearm Fracture Drug: Ibuprofen Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture
Study Start Date : April 2012
Primary Completion Date : June 2016
Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: NSAIDs in 7 days
NSAIDs (Ibuprofen) in 7 days
Drug: Ibuprofen
Treatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis
Other Name: M01AE01 7 days
Active Comparator: NSAIDs in 3 days
NSAIDs (Ibuprofen) in the first 3 days and placebo in the last 4 days
Drug: Ibuprofen
Treatment with Ibuprofen 600mg 3 times daily in 3 days after´diagnosis - Colles fracture
Other Name: M01AE01 3 days
Placebo Comparator: Placebo
Only placebo in 7 days
Drug: Placebo
Only placebo treatment instead of NSAID painkillers
Other Name: M01AE01 0 days

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567072

Department of Orthopaedic Surgery, Aalborg University Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Marius Aliuskevicius
University of Aarhus
Principal Investigator: Marius Aliuskevicius, Physician Aalborg Universitetshospital

Additional Information:
Responsible Party: Marius Aliuskevicius, Principal Investigator, Aalborg Universitetshospital
ClinicalTrials.gov Identifier: NCT01567072     History of Changes
Other Study ID Numbers: 2010-018543-34
First Posted: March 30, 2012    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016

Keywords provided by Marius Aliuskevicius, Aalborg Universitetshospital:
bone fracture

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action