Forearm FracturePhase 3CHIPNCT01567072
Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture
A Phase 3 study testing Ibuprofen in people with Forearm Fracture, run by Marius Aliuskevicius at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Forearm Fracture
- What is being tested?
- Ibuprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2012to Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written acceptance to participate in the study
- immobilisation or reposition or surgery demanding Colles fracture (which needs to be fixed with external fixation).
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Orthopaedic Surgery, Aalborg University Hospital
Aalborg, 9000
About this study
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.
Read more
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.
- Conditions
- Forearm Fracture
- Being tested
- Ibuprofen, Placebo
- Keywords
- NSAID, bone fracture, heal
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called M01AE01 7 days
Treatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis
IbuprofenDrug
Also called M01AE01 3 days
Treatment with Ibuprofen 600mg 3 times daily in 3 days after´diagnosis - Colles fracture
PlaceboDrug
Also called M01AE01 0 days
Only placebo treatment instead of NSAID painkillers
| Study group | Role | What they receive |
|---|---|---|
| NSAIDs in 7 days | Experimental | NSAIDs (Ibuprofen) in 7 days Receives: Drug: Ibuprofen |
| NSAIDs in 3 days | Active comparator | NSAIDs (Ibuprofen) in the first 3 days and placebo in the last 4 days Receives: Drug: Ibuprofen |
| Placebo | Placebo comparator | Only placebo in 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of changes of fractures position by X rays investigation
Measurement of possible secondary dislocation
Measured: 1 week, 2 weeks, 6 weeks
Secondary outcomes (3)
DEXA - scanning
Evaluation of bone density
Measured: 12 weeks
Bone Biochemical markers
Se CrossLaps ELISA, N/Mid Osteocalcin Elisa
Measured: 1 week, 2 weeks, 5 weeks, 3 months, 1 year
Histomorfometrical evaluation of bone biopsy from callus area
qualitative evaluation of bone ossification
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Forearm FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marius Aliuskevicius
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor-investigator, Marius Aliuskevicius, Aalborg University Hospital
- Investigators
- Marius Aliuskevicius, Physician, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567072
- Sponsor's protocol ID
- 2010-018543-34
- Acronym
- CHIP
- Status last verified
- Sep 2016
- First submitted
- 20 Mar 2012
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16470423
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT01567072
- Acronym / sponsor ID
- CHIP / 2010-018543-34
- Conditions
- Forearm Fracture
- Keywords
- NSAID, bone fracture, heal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Marius AliuskeviciusUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- Apr 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NSAIDs in 7 days | Experimental | Drug: IbuprofenNSAIDs (Ibuprofen) in 7 days |
| NSAIDs in 3 days | Active comparator | Drug: IbuprofenNSAIDs (Ibuprofen) in the first 3 days and placebo in the last 4 days |
| Placebo | Placebo comparator | Drug: PlaceboOnly placebo in 7 days |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- written acceptance to participate in the study
- immobilisation or reposition or surgery demanding Colles fracture (which needs to be fixed with external fixation).
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenAlso: M01AE01 7 daysTreatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis | Drug | NSAIDs in 7 days |
| IbuprofenAlso: M01AE01 3 daysTreatment with Ibuprofen 600mg 3 times daily in 3 days after´diagnosis - Colles fracture | Drug | NSAIDs in 3 days |
| PlaceboAlso: M01AE01 0 daysOnly placebo treatment instead of NSAID painkillers | Drug | Placebo |
Primary outcome
Evaluation of changes of fractures position by X rays investigation
Time frame: 1 week, 2 weeks, 6 weeks
Measurement of possible secondary dislocation
3 secondary outcomes
DEXA - scanning
Time frame: 12 weeks
Bone Biochemical markers
Time frame: 1 week, 2 weeks, 5 weeks, 3 months, 1 year
Histomorfometrical evaluation of bone biopsy from callus area
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Background: PubMed 16470423Persson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marius Aliuskevicius, Physician principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibuprofen in people with Forearm Fracture, run by Marius Aliuskevicius at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of changes of fractures position by X rays investigation (time frame: 1 week, 2 weeks, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01567072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.