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

Not Applicable

Recruiting

• Conditions: Diseases of the musculo-skeletal system and connective tissue

• Registration Number: KCT0004294
• Lead Sponsor: Ewha Womans University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

? Adult patients whose age is over 20 years of age and whose jaw growth has been completed
? 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
? 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.)
? Patients who agreed to participate in the clinical trial and signed the patient consent form

Exclusion Criteria

? If there is a history of radiation therapy in the head and neck, including jaw, or a malignant tumor of the jaw area
? Patients taking oral bisphosphonate for 2 years or less
? If the examiner determines that participation in the clinical trial is inadeqyate becayse it may affect other ethical or clinical trial results

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Clinical characteristic / Demographic evaluation;Radiation examination