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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Aalborg Universitetshospital
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
Marius Aliuskevicius, Aalborg Universitetshospital
ClinicalTrials.gov Identifier:
NCT01567072
First received: March 20, 2012
Last updated: January 13, 2015
Last verified: January 2015
  Purpose

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 Intervention Phase
Forearm Fracture
Drug: Ibuprofen
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture

Resource links provided by NLM:


Further study details as provided by Aalborg Universitetshospital:

Primary Outcome Measures:
  • Evaluation of changes of fractures position by X rays investigation [ Time Frame: 1 week, 2 weeks, 6 weeks ] [ Designated as safety issue: Yes ]
    Measurement of possible secondary dislocation


Secondary Outcome Measures:
  • DEXA - scanning [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Evaluation of bone density

  • Bone Biochemical markers [ Time Frame: 1 week, 2 weeks, 5 weeks, 3 months, 1 year ] [ Designated as safety issue: Yes ]
    Se CrossLaps ELISA, N/Mid Osteocalcin Elisa

  • Histomorfometrical evaluation of bone biopsy from callus area [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    qualitative evaluation of bone ossification


Other Outcome Measures:
  • Repeated measurements of pain in 14 days [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    subjective pain registration in 10 points scala 3 times dayly in 14 days


Estimated Enrollment: 192
Study Start Date: April 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567072

Contacts
Contact: Marius Aliuskevicius, Physician +45 26910156 aliuskevicius@yahoo.dk
Contact: Jane Dorthea Livoni, Therapist +45 99369118 jane.dorthea.livoni@rn.dk

Locations
Denmark
Department of Orthopaedic Surgery, Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Marius Aliuskevicius, Physician    +45 99325195    marali@rn.dk   
Principal Investigator: Marius Aliuskevicius, Physician         
Sponsors and Collaborators
Marius Aliuskevicius
University of Aarhus
Investigators
Principal Investigator: Marius Aliuskevicius, Physician Aalborg Universitetshospital
  More Information

Additional Information:
Publications:
Responsible Party: Marius Aliuskevicius, Principal Investigator, Aalborg Universitetshospital
ClinicalTrials.gov Identifier: NCT01567072     History of Changes
Other Study ID Numbers: 2010-018543-34
Study First Received: March 20, 2012
Last Updated: January 13, 2015
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Aalborg Universitetshospital:
NSAID
bone fracture
heal

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

ClinicalTrials.gov processed this record on May 21, 2015