OsteonecrosisPhase 1NCT00462098
Randomized Controlled Trial of Hyperbaric Oxygen in Patients Who Have Taken Bisphosphonates
A Phase 1 study testing hyperbaric oxygen in people with Osteonecrosis, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteonecrosis
- What is being tested?
- hyperbaric oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Able to consent
- Meets definition of ONJ
- Has taken amino-bisphosphonates
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
Read the 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).
- Conditions
- Osteonecrosis
- Being tested
- hyperbaric oxygen, non-treated control group
- Keywords
- Osteonecrosis of the jaw, hyperbaric oxygen, bisphosphonates
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric oxygenDevice
40 sessions of 100% oxygen at 2 atmospheres of pressure for 2 hours each
non-treated control groupDevice
no change from routine care, no HBO
| Study group | Role | What they receive |
|---|---|---|
| HBO | Experimental | Subject receives 40 HBO sessions at 2 atmospheres of pressure over 4 weeks Receives: Device: hyperbaric oxygen |
| Control | Active comparator | non-HBO comparison group Receives: Device: non-treated control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome assessments. Effect of HBO as an adjunct to the routine treatment of ONJ will be evaluated by physical exam and pain scores
Measured: Weekly for pain score. All others at: 3 months 6 months 12 months 18 months
Secondary outcomes (3)
Quality of life measurements by the Duke Health Profile
Measured: 3 months, 6 months, 12 months and 18 months
Laboratory measures of bone turnover
Measured: 3 months, 6 months 12 months and 18 months
Molecular indicators of osteoclast activation (RANK, RANKL, OPG, pAKt)
Measured: 3 months 6 months 12 months 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startAug 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteonecrosisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Freiberger, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462098
- Sponsor's protocol ID
- Pro00007527
- Status last verified
- Feb 2013
- First submitted
- 17 Apr 2007
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beth-Tasdogan NH, Mayer B, Hussein H, Zolk O, Peter JU. Interventions for managing medication-related osteonecrosis of the jaw. Cochrane Database Syst Rev. 2022 Jul 12;7(7):CD012432. doi: 10.1002/14651858.CD012432.pub3.
PubMed 35866376
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Hyperbaric Oxygen in Patients Who Have Taken Bisphosphonates
- ClinicalTrials.gov ID
- NCT00462098
- Acronym / sponsor ID
- Pro00007527
- Conditions
- Osteonecrosis
- Keywords
- Osteonecrosis of the jaw, hyperbaric oxygen, bisphosphonates
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBO | Experimental | Device: hyperbaric oxygenSubject receives 40 HBO sessions at 2 atmospheres of pressure over 4 weeks |
| Control | Active comparator | Device: non-treated control groupnon-HBO comparison group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Able to consent
- Meets definition of ONJ
- Has taken amino-bisphosphonates
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperbaric oxygen40 sessions of 100% oxygen at 2 atmospheres of pressure for 2 hours each | Device | HBO |
| non-treated control groupno change from routine care, no HBO | Device | Control |
Primary outcome
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
3 secondary outcomes
Quality of life measurements by the Duke Health Profile
Time frame: 3 months, 6 months, 12 months and 18 months
Laboratory measures of bone turnover
Time frame: 3 months, 6 months 12 months and 18 months
Molecular indicators of osteoclast activation (RANK, RANKL, OPG, pAKt)
Time frame: 3 months 6 months 12 months 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
- Derived from this study: PubMed 35866376Beth-Tasdogan NH, Mayer B, Hussein H, Zolk O, Peter JU. Interventions for managing medication-related osteonecrosis of the jaw. Cochrane Database Syst Rev. 2022 Jul 12;7(7):CD012432. doi: 10.1002/14651858.CD012432.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Freiberger, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hyperbaric oxygen in people with Osteonecrosis, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00462098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2013.