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

Marius Aliuskevicius

Status and phase: Completed; Phase 3

Conditions: Forearm Fracture

Treatments: Drug: Placebo; Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT01567072

2010-018543-34

Details and patient eligibility

About

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.

Enrollment: 192 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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192 participants in 3 patient groups, including a placebo group

NSAIDs in 7 days

Experimental group

Description:

NSAIDs (Ibuprofen) in 7 days

Treatment:

Drug: Ibuprofen

Drug: Ibuprofen

NSAIDs in 3 days

Active Comparator group

Description:

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

Treatment:

Drug: Ibuprofen

Drug: Ibuprofen

Placebo

Placebo Comparator group

Description:

Only placebo in 7 days

Treatment:

Drug: Placebo