Randomized Controlled Trial of Hyperbaric Oxygen in Patients Who Have Taken Bisphosphonates

Completed · Phase 1

Conditions studied: Osteonecrosis

In brief

Osteonecrosis of the jaw (ONJ) has recently been recognized as associated with bisphosphonate therapy, however there is little information on the natural history, treatment or prevention strategies for this condition. The purpose of this study is to determine the effectiveness of hyperbaric oxygen as a treatment. We will randomize 35 out of 70 ONJ patients to receive HBO in addition to their routine oral surgery care and follow both groups over a 2-year period.

Key facts

Study ID

NCT00462098

Run by

Duke University

People needed

54

Starts

2006-08-01

Expected to finish

2010-12-01

Last updated by the study team

2013-02-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to consent
• Meets definition of ONJ
• Has taken amino-bisphosphonates

You may not qualify if…

• Unable to consent
• Ineligible for HBO
• Taking protease inhibitors for HIV
• Any past history of radiation to head or neck
• Life expectancy less than 12 months
• Tobacco use

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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