Randomized Controlled Trial of Hyperbaric Oxygen in Patients Who Have Taken Bisphosphonates
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 strategies for this condition1. Bisphosphonates, particularly compounds containing
an aliphatic chain with an amino group in the R2 position, (pamidronate, alendronate and
zoledronate) are extremely effective and widely used in the treatment of breast cancer,
prostate cancer, multiple myeloma and non-malignant bone disease. Although ONJ appears to
develop in less than one percent of patients taking these drugs, the seriousness of the
disease plus the current lack of treatment options makes this a very difficult clinical
problem This study will randomize 35 out of 70 patients to receive HBO in addition to their
routine oral surgery therapy for ONJ and follow both groups over a 2-year period. The study
design is an interventional, prospective, randomized trial with a 2-year follow up period.
Seventy subjects meeting the inclusion criteria for ONJ will be recruited by participating
physicians and randomized to receive 40 HBO treatments over a 4 week period or to continue
their normal oral care. No subject, HBO treated or not, will be asked to change, initiate or
discontinue any ongoing therapies they may be receiving from their primary care giver for ONJ
or any other medical condition. The analysis will compare remission rates between the two
groups while controlling for age, gender, race, previous local trauma or surgery, tumor type,
diabetes, immunosuppression, bisphosphonate duration, indication (hypercalcemia), infection,
corticosteroids, and thalidomide and dental hygiene. All subjects will be closely followed
throughout the 24 month course of the study with weekly contacts by phone or email to log jaw
pain level as well as to record any change in general medical condition. The 17 question Duke
Health Profile will be used to measure quality of life indicators at 4 key points during the
study.
Comparison(s): 1) clinical remission rate in patients receiving and not receiving HBO. 2)
Bone turnover and molecular measures of osteoclast signaling in ONJ patients before and after
HBO and relative to non-diseased controls (labs from non-diseased controls to be obtained
from a companion study).
Condition:
Osteonecrosis
Treatment:
hyperbaric oxygen
Start Date:
August 2006
Sponsor:
Duke University
For More Information:
https://clinicaltrials.gov/show/NCT00462098