Bone DiseasesNCT01325142
Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer
An observational study of Bone Diseases and Metastases, run by University of Michigan at 1 site in United States.
Trial summary
This study seeks to identify risk factors associated with the development of a jaw condition seen in patients with cancer treated with certain medications. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Bone Diseases, Metastases, Osteonecrosis
- How many people
- 271 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Nov 2014
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Academic medical center(s)
Who may be able to join
- The study candidate must have sufficient Formalin Fixed Paraffin Embedded (FFPE)Specimens (lymph node or tumor) for DNA extraction available for study SNP assessment
- Patients over the age of 21 with a histologically confirmed diagnosis of cancer who have received nitrogen containing bisphosphonate therapy for metastatic bone disease.
- FFPE tissues are to have been removed for clinical indication and sufficience study volume of specimen must be available in an established tissue repository.
- - Study FFPE tissues include:
- formalin fixed paraffin embedded leukocytes from lymph nodes with or without involvement by tumor AND/OR
- formalin fixed paraffin embedded tumor tissue (tumor block without invasive cancer is acceptable if the specimen is believed to be sufficiently cellular (breast tissue or noninvasive cancer) to yield adequate DNA)
- Medical records available for data abstraction
Who cannot join
- Insufficient specimen available to perform the assays proposed for specimen DNA analysis
- No accessable medical records
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to identify risk factors associated with the development of a jaw condition seen in patients with cancer treated with certain medications.
Read the detailed description
The goal of this research is to build an index of risk for estimating an individual's risk of developing osteonecrosis of the jaw (ONJ). The bisphosphonates are an important supportive therapy in the care of patients with metastatic bone disease; they are able to prevent catastrophic events such as fracture and spinal cord compression. However, ONJ has been associated with the use of the bisphosphonates and ONJ carries significant morbidity. Presently, there are insufficient data to calculate the ONJ risk benefit ratio of bisphosphonate use. An ONJ risk assessment tool would improve both the oncologist's and the dental health professional the ability to anticipate and potentially mitigate oral toxicities from bisphosphonate therapy.
This protocol consists of a case (ONJ) control (no ONJ) study to identify factors associated with the risk of ONJ and to build an index predictive of an individual's risk of developing ONJ. The index of ONJ risk will be comprised of clinical, epidemiologic and genetic factors
- Conditions
- Bone Diseases, Metastases, Osteonecrosis, Bisphosphonate-Associated Osteonecrosis of the Jaw
- Keywords
- Osteonecrosis of the Jaw (ONJ)
- Medical subject headings
- Bone Diseases, Neoplasm Metastasis, Osteonecrosis, Bisphosphonate-Associated Osteonecrosis of the Jaw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ONJ | Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has developed ONJ | |
| No ONJ | Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has NOT developed ONJ |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify clinical and epidemiologic characteristics associated with ONJ in patients with metastatic bone disease treated with a nitrogen containing bisphosphonate.
analysis is ongoing
Measured: 2009-2014
To identify single nucleotide polymorphisms (SNPs) in genes affected by osteoclast inhibiting therapy that are associated with an increased risk of developing ONJ in patients with metastatic bone disease treated with nitrogen containing bisphosphonates.
analysis is ongoing
Measured: 2009-2014
To generate a multifactorial index of ONJ risk by multivariate analysis of the clinical, epidemiologic and genetic factors
analysis is ongoing
Measured: 2009-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startAug 2010
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DiseasesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Indiana University, M.D. Anderson Cancer Center, Memorial Sloan Kettering Cancer Center
- Responsible party
- Principal investigator, Catherine Van Poznak, University of Michigan
- Investigators
- Catherine Van Poznak, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325142
- Sponsor's protocol ID
- HUM00040101
- Other IDs
- 5K23DE020197-02
- Status last verified
- Dec 2014
- First submitted
- 28 Mar 2011
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer
- ClinicalTrials.gov ID
- NCT01325142
- Acronym / sponsor ID
- HUM00040101
- Conditions
- Bone Diseases, Metastases, Osteonecrosis, Bisphosphonate-Associated Osteonecrosis of the Jaw
- Keywords
- Osteonecrosis of the Jaw (ONJ)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Indiana University, M.D. Anderson Cancer Center, Memorial Sloan Kettering Cancer Center
- Study start
- Aug 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 29 Mar 2011 (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.
This study seeks to identify risk factors associated with the development of a jaw condition seen in patients with cancer treated with certain medications.
Detailed description
The goal of this research is to build an index of risk for estimating an individual's risk of developing osteonecrosis of the jaw (ONJ). The bisphosphonates are an important supportive therapy in the care of patients with metastatic bone disease; they are able to prevent catastrophic events such as fracture and spinal cord compression. However, ONJ has been associated with the use of the bisphosphonates and ONJ carries significant morbidity. Presently, there are insufficient data to calculate the ONJ risk benefit ratio of bisphosphonate use. An ONJ risk assessment tool would improve both the oncologist's and the dental health professional the ability to anticipate and potentially mitigate oral toxicities from bisphosphonate therapy.
This protocol consists of a case (ONJ) control (no ONJ) study to identify factors associated with the risk of ONJ and to build an index predictive of an individual's risk of developing ONJ. The index of ONJ risk will be comprised of clinical, epidemiologic and genetic factors
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONJ | – | –Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has developed ONJ |
| No ONJ | – | –Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has NOT developed ONJ |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Academic medical center(s)
Key inclusion criteria (7 listed)
- The study candidate must have sufficient Formalin Fixed Paraffin Embedded (FFPE)Specimens (lymph node or tumor) for DNA extraction available for study SNP assessment
- Patients over the age of 21 with a histologically confirmed diagnosis of cancer who have received nitrogen containing bisphosphonate therapy for metastatic bone disease.
- FFPE tissues are to have been removed for clinical indication and sufficience study volume of specimen must be available in an established tissue repository.
- - Study FFPE tissues include:
- Medical records available for data abstraction
Key exclusion criteria (2 listed)
- Insufficient specimen available to perform the assays proposed for specimen DNA analysis
- No accessable medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify clinical and epidemiologic characteristics associated with ONJ in patients with metastatic bone disease treated with a nitrogen containing bisphosphonate.
Time frame: 2009-2014
analysis is ongoing
To identify single nucleotide polymorphisms (SNPs) in genes affected by osteoclast inhibiting therapy that are associated with an increased risk of developing ONJ in patients with metastatic bone disease treated with nitrogen containing bisphosphonates.
Time frame: 2009-2014
analysis is ongoing
To generate a multifactorial index of ONJ risk by multivariate analysis of the clinical, epidemiologic and genetic factors
Time frame: 2009-2014
analysis is ongoing
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 2 Dec 2014.
Related trials for Bone Diseases
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
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.
Catherine Van Poznak, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Diseases and Metastases, run by University of Michigan 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 7 inclusion and 2 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 2 Dec 2014. 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.
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?
To identify clinical and epidemiologic characteristics associated with ONJ in patients with metastatic bone disease treated with a nitrogen containing bisphosphonate. (time frame: 2009-2014). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2014.