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Validation study of biomarker for Medication-related Osteonecrosis of Jaw (MRONJ)

Status Approved

First Submitted Date

2019/02/18
Registered Date

2019/09/11
Last Updated Date

2019/09/09

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0004294
Unique Protocol ID	NRF-2016R1C1B2006270
Public/Brief Title	Validation study of biomarker for Medication-related Osteonecrosis of Jaw (MRONJ)
Scientific Title	Validation study of biomarker for Medication-related Osteonecrosis of Jaw (MRONJ)
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	EUMC 2018-01-046-010
Approval Date	2018-04-20
Institutional Review Board Name	Ewha Womans University Mok-dong Hospital IRB
Institutional Review Board Address	1071, Anyangcheon-ro, Yangcheon-gu, Seoul
Institutional Review Board Telephone	02-2650-5872
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Jin Woo Kim
Title	Professor
Telephone	+82-2-2650-5680
Affiliation	Ewha Womans University Medical Center
Address	1071, Anyangcheon-ro, Yangcheon-gu, Seoul
Contact Person for Public Queries
Name	Seon Hyeon Kim
Title	Researcher
Telephone	+82-2-2650-5903
Affiliation	Ewha Womens University
Address	52, Ewha Womans University-gil, Seodaemun-gu, Seoul
Contact Person for Updating Information
Name	Seon Hyeon Kim
Title	Researcher
Telephone	+82-2-2650-5903
Affiliation	Ewha Womens University
Address	52, Ewha Womans University-gil, Seodaemun-gu, Seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2018-04-23 Actual
Target Number of Participant	87
Primary Completion Date
Study Completion Date
Name of Study	Ewha Womans University Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2018-04-23 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	National Research Foundation
Organization Type	Others
Project ID	NRF-2016R1C1B2006270

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Ewha Womans University Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Since the first report of osteonecrosis of the jaw associated with bisphosphonate (BP) administration in 2003, there have been many efforts to establish the pathophysiologic nature of this disease. Given the fact that its pathogenesis is still poorly understood, and the global dependence on BP use and the entry tor aging society, there is a pressing need of related investigations. Current project therefore aims to investigate pathophysiologic mechanism of BRONJ through detection of new biomarkers, and to propose the evidence-based approach for prevention and treatment.

Study Summary Information

Lay Summary

Since the first report of osteonecrosis of the jaw associated with bisphosphonate (BP)  administration in 2003, there have been many efforts to establish the pathophysiologic nature of this disease. Given the fact that its pathogenesis is still poorly understood, and the global dependence on BP use and the entry tor aging society, there is a pressing need of related investigations. Current project therefore aims to investigate pathophysiologic mechanism of BRONJ through detection of new biomarkers, and to propose the evidence-based approach for prevention and treatment.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-only
Time Perspective	Prospective
Target Number of Participant	87
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Patients receiving an intraoral surgical treatment in patients receiving antiresorptive drug or angiogenesis inhibitors
Cohort/ Group 1	Cohort/Group Description The patients who were diagnosed with BRONJ through outpatient visits and hospitalization, patients with no history of BRONJ but with bisphosphonate use, patients with antitumor to malignant tumors, and patients with multiple myeloma were collected. And Initial examination, Baseline laboratory tests, intraoral examinations, radiological examinations, and blood tests were conducted to compare the presence or absence of jaw changes.
Biospecimen Collection & Archiving	: DNA Collect & Archive: Sample with DNA
Biospecimen Description	whole blood

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Patients who were treated at Oral & Maxillofacial Surgery, Mokdong Hospital, Ewha Womans University, Seoul, Korea
Sampling Method	Non-probablity sampling.purposive sampling
Condition(s)/Problem(s)	* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M87.99)Osteonecrosis, unspecified, site unspecified 1) Medication-Related osteonecrosis of jaw 2) Diseases in which bisphosphonates are administered to osteoporosis, multiple myeloma, breast cancer, etc.
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~No Limit
	Description ① Adult patients whose age is over 20 years of age and whose jaw growth has been completed ② If you have or have been given a medication that can cause jaw necrosis:IV Bisphosphonate, Denosumab, Angiogenesis inhibitor, etc.Oral use for more than 2 years ③ Patients who are scheduled to perform an action that increases the risk of jaw necrosis or have a risk factor (Oral surgery such as extraction, implant, and denture that does not fit well, periodontitis, etc.) ④ Patients who agreed to participate in the clinical trial and signed the patient consent form
Exclusion Criteria	① If there is a history of radiation therapy in the head and neck, including jaw, or a malignant tumor of the jaw area ② Patients taking oral bisphosphonate for 2 years or less ③ If the examiner determines that participation in the clinical trial is inadeqyate becayse it may affect other ethical or clinical trial results
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Blood tests: Calcitonin, C-telopeptide of collagen type 1 (CTX), N-telopeptide (NTX), PYRILINKS-D(Deoxypyridinoline), Osteocalcin, Bone sepcific Alkaline phosphatase (ALP), Parathyroid Hormone (PTH) Intact, 1,25-(OH)2 (1.25 dihydroxy Vitamin D), total, Total calcium
Timepoint	Visit T0(Initial), T1(8 weeks), T2(4~5 months), T3(6~12 months)
Secondary Outcome(s) 1
Outcome	Clinical characteristic / Demographic evaluation
Timepoint	Visit T0(Initial), T1(8 weeks), T2(4~5 months), T3(6~12 months)
Secondary Outcome(s) 2
Outcome	Radiation examination
Timepoint	Visit T0(Initial), T1(8 weeks), T2(4~5 months), T3(6~12 months)

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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