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NCT00462098 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Osteonecrosis, sponsored by Duke University.

Completed
Registry status
Phase 1
Development phase
54
Enrollment target
1
Study location

NCT00462098 is a Phase 1 study of Osteonecrosis that has completed, run by Duke University. The registered enrollment target is 54 participants, below the 2,915-participant average among 7 other Osteonecrosis trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00462098, a Phase 1 study of Osteonecrosis, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 1
Development phase
54 participants
Enrollment target
1
Study location

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 Studied

Osteonecrosis

Interventions

  • DEVICE hyperbaric oxygen
  • DEVICE non-treated control group

Study Locations (1)

North Carolina

  • Duke University Medical Center - Durham

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2006-08
Est. Completion 2010-12
Phase Phase 1

Sponsor

Duke University

1,725 total trials

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What the Registry Record Tells You About NCT00462098

The ClinicalTrials.gov registry entry for NCT00462098 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,915-participant average among 7 other Osteonecrosis trials with a reported enrollment target (98% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Osteonecrosis appearing as the primary indexed condition, and to 2 interventions - of which hyperbaric oxygen is the first listed.

NCT00462098 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT00462098 about?

NCT00462098 is a clinical study titled "Randomized Controlled Trial of Hyperbaric Oxygen in Patients Who Have Taken Bisphosphonates". 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 a...

What is the current status of trial NCT00462098?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2006-08. Estimated completion is 2010-12.

What conditions does trial NCT00462098 study?

This clinical trial studies the following conditions: Osteonecrosis.

What interventions are being tested in trial NCT00462098?

The interventions under investigation include: hyperbaric oxygen (DEVICE), non-treated control group (DEVICE).

Who is sponsoring clinical trial NCT00462098?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00462098 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.