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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00462098
First received: April 17, 2007
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Osteonecrosis
Device: hyperbaric oxygen
Device: non-treated control group
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Hyperbaric Oxygen in Patients Who Have Taken Bisphosphonates

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Clinical outcome assessments. Effect of HBO as an adjunct to the routine treatment of ONJ will be evaluated by physical exam and pain scores [ Time Frame: Weekly for pain score. All others at: 3 months 6 months 12 months 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life measurements by the Duke Health Profile [ Time Frame: 3 months, 6 months, 12 months and 18 months ] [ Designated as safety issue: No ]
  • Laboratory measures of bone turnover [ Time Frame: 3 months, 6 months 12 months and 18 months ] [ Designated as safety issue: No ]
  • Molecular indicators of osteoclast activation (RANK, RANKL, OPG, pAKt) [ Time Frame: 3 months 6 months 12 months 18 months ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: August 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HBO
Subject receives 40 HBO sessions at 2 atmospheres of pressure over 4 weeks
Device: hyperbaric oxygen
40 sessions of 100% oxygen at 2 atmospheres of pressure for 2 hours each
Active Comparator: Control
non-HBO comparison group
Device: non-treated control group
no change from routine care, no HBO

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 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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to consent
  • Meets definition of ONJ
  • Has taken amino-bisphosphonates

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462098

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: John Freiberger, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00462098     History of Changes
Other Study ID Numbers: Pro00007527
Study First Received: April 17, 2007
Last Updated: February 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Osteonecrosis of the jaw
hyperbaric oxygen
bisphosphonates

Additional relevant MeSH terms:
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014