UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048986 |
|---|---|
| Receipt number | R000055801 |
| Scientific Title | Evaluation and clinical application of a quality of life scale for patients with medication-related osteonecrosis of the jaw (MRONJ) |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2022/09/21 14:14:52 |
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Basic information
Public title
Evaluation and clinical application of a quality of life scale for patients with medication-related osteonecrosis of the jaw
Acronym
Evaluation and clinical application of a quality of life scale for patients with medication-related osteonecrosis of the jaw
Scientific Title
Evaluation and clinical application of a quality of life scale for patients with medication-related osteonecrosis of the jaw (MRONJ)
Scientific Title:Acronym
Evaluation and clinical application of a quality of life scale for patients with medication-related osteonecrosis of the jaw (MRONJ)
Region
| Japan |
Condition
Condition
Medication-Related Osteonecrosis of the Jaw
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Bone-modifying drugs such as bisphosphonates (BPs) and denosumab (Dmab) have been administered to treat osteoporosis, bone metastases of malignant tumors, and bone-related events in multiple myeloma. However, many cases of medication-related osteonecrosis of the jaws (MRONJ) have been reported. MRONJ can cause symptoms such as jawbone pain, swelling, and drainage of pus, and if not treated appropriately, can lead to pathological fractures, masticatory dysfunction, and sometimes sepsis. It is rare for MRONJ to be cured by conservative treatment such as administration of antimicrobial agents, and surgical resection of necrotic bone is often required, which is a significant burden for patients undergoing cancer treatment. This study aims to develop an evaluation method for patients with MRONJ who have undergone either conservative or surgical treatment, using quality of life as the outcome measure for each. Objective evaluation of the impact of conservative or aggressive surgical treatment on patients' QOL and high-quality evidence will be expected to be helpful in selecting treatment options for both health care providers and patients in the medical field.
Basic objectives2
Others
Basic objectives -Others
This study aims to develop an evaluation method using QOL as a scale for MRONJ patients who have undergone conservative or surgical treatment. Since the evaluation of QOL is a subjective, multidimensional, and multifactorial concept, it is not easy to accurately grasp the information in a way that everyone can understand and to create an appropriate evaluation method. We aim to establish an evaluation method using a QOL scale that can be used across differentiation in international collaborative clinical research and clinical trials, for which demand has been increasing rapidly in recent years.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient information (basic patient information, risk factors (lifestyle, etc.), treatment history, blood test data before and after treatment, imaging findings, information on underlying disease, and outcome) will be obtained from patient questionnaires and medical records for patients diagnosed with MRONJ. An explanatory questionnaire form (attached) will be distributed to research subjects, and the names of research subjects will be filled in and the data will be tabulated.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with medication-related osteonecrosis of the jaw (MRONJ) at Hiroshima University Hospital
Key exclusion criteria
Patients who refused to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sachiko |
| Middle name | |
| Last name | Yamasaki |
Organization
Hiroshima University
Division name
Department of Oral Oncology,Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi, Minami Ward, Hiroshima
TEL
082-257-5667
sayamasaki@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Yamasaki |
Organization
Hiroshima University
Division name
Department of Oral Oncology,Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi, Minami Ward, Hiroshima
TEL
082-257-5667
Homepage URL
sayamasaki@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University hospital IRB
Address
1-2-3 Kasumi, Minami Ward, Hiroshima
Tel
082-257-5596
hugcp@hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Basic patient information, risk factors (lifestyle, etc.), treatment history, blood test data before and after treatment, imaging findings, information on underlying diseases, and outcomes
Management information
Registered date
| 2022 | Year | 09 | Month | 21 | Day |
Last modified on
| 2022 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055801
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
