Status:
COMPLETED
Randomized Controlled Trial of Hyperbaric Oxygen in Patients Who Have Taken Bisphosphonates
Lead Sponsor:
Duke University
Conditions:
Osteonecrosis
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
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 fo...
Detailed Description
Osteonecrosis of the jaw (ONJ) has recently been recognized as associated with bisphosphonate (BP) therapy, however there is little information on the natural history, treatment or prevention strategi...
Eligibility Criteria
Inclusion
- Able to consent
- Meets definition of ONJ
- Has taken amino-bisphosphonates
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00462098
Start Date
August 1 2006
End Date
December 1 2010
Last Update
February 21 2013
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710