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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: Completed Phase 1 study of Osteonecrosis, sponsored by Duke University.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Interventions
- DEVICE hyperbaric oxygen
- DEVICE non-treated control group
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2006-08 |
| Est. Completion | 2010-12 |
| Phase | Phase 1 |
What the finished NCT00462098 record still lists
NCT00462098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 2,915-participant average among 7 other Osteonecrosis trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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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