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

NCT00462098 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2013-02-21

No results posted yet for this study

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 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.

Conditions

  • Osteonecrosis

Interventions

DEVICE

hyperbaric oxygen

40 sessions of 100% oxygen at 2 atmospheres of pressure for 2 hours each

DEVICE

non-treated control group

no change from routine care, no HBO

Sponsors & Collaborators

Principal Investigators

  • John Freiberger, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00462098 on ClinicalTrials.gov