Ie-Wen Sim1,2, Gelsomina L Borromeo3, Claudine Tsao3, Rita Hardiman3, Michael S Hofman4, Christian Papatziamos Hjelle5, Musib Siddique5, Gary J R Cook5, John F Seymour1,6, Peter R Ebeling2. 1. Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia. 2. Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Victoria, Australia. 3. Melbourne Dental School, University of Melbourne, Melbourne, Victoria, Australia. 4. Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia. 5. School of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom. 6. Department of Haematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, Victoria, Australia.
Abstract
PURPOSE:Medication-related osteonecrosis of the jaw (MRONJ) is an infrequent but morbid and potentially serious condition associated with antiresorptive and antiangiogenic therapies. Although MRONJ can be prevented by optimizing oral health, management of established cases is supportive and remains challenging. Teriparatide, an osteoanabolic agent that improves bone healing in preclinical studies and in chronic periodontitis, represents a potential treatment option. PATIENTS AND METHODS: In a double-blind, randomized, controlled trial, 34 participants with established MRONJ, with a total of 47 distinct MRONJ lesions, were allocated to either 8 weeks of subcutaneous teriparatide (20 µg/day) or placebo injections, in addition to calcium and vitamin D supplementation and standard clinical care. Participants were observed for 12 months, with primary outcomes that included the clinical and radiologic resolution of MRONJ lesions. Secondary outcomes included osteoblastic responses as measured biochemically and radiologically and changes in quality of life. RESULTS:Teriparatide was associated with a greater rate of resolution of MRONJ lesions (odds ratio [OR], 0.15 v 0.40; P = .013), and 45.4% of lesions resolved by 52 weeks compared with 33.3% in the placebo group. Teriparatide was also associated with reduced bony defects at week 52 (OR, 8.1; P = .017). The incidence of adverse events was balanced between groups, including nausea, anorexia, and musculoskeletal pain, most of mild severity. CONCLUSION:Teriparatide improves the rate of resolution of MRONJ lesions and represents an efficacious and safe treatment for it.
RCT Entities:
PURPOSE: Medication-related osteonecrosis of the jaw (MRONJ) is an infrequent but morbid and potentially serious condition associated with antiresorptive and antiangiogenic therapies. Although MRONJ can be prevented by optimizing oral health, management of established cases is supportive and remains challenging. Teriparatide, an osteoanabolic agent that improves bone healing in preclinical studies and in chronic periodontitis, represents a potential treatment option. PATIENTS AND METHODS: In a double-blind, randomized, controlled trial, 34 participants with established MRONJ, with a total of 47 distinct MRONJ lesions, were allocated to either 8 weeks of subcutaneous teriparatide (20 µg/day) or placebo injections, in addition to calcium and vitamin D supplementation and standard clinical care. Participants were observed for 12 months, with primary outcomes that included the clinical and radiologic resolution of MRONJ lesions. Secondary outcomes included osteoblastic responses as measured biochemically and radiologically and changes in quality of life. RESULTS:Teriparatide was associated with a greater rate of resolution of MRONJ lesions (odds ratio [OR], 0.15 v 0.40; P = .013), and 45.4% of lesions resolved by 52 weeks compared with 33.3% in the placebo group. Teriparatide was also associated with reduced bony defects at week 52 (OR, 8.1; P = .017). The incidence of adverse events was balanced between groups, including nausea, anorexia, and musculoskeletal pain, most of mild severity. CONCLUSION:Teriparatide improves the rate of resolution of MRONJ lesions and represents an efficacious and safe treatment for it.
Authors: Jin-Woo Kim; Mi Kyung Kwak; Jeong Joon Han; Sung-Tak Lee; Ha Young Kim; Se Hwa Kim; Junho Jung; Jeong Keun Lee; Young-Kyun Lee; Yong-Dae Kwon; Deog-Yoon Kim Journal: J Bone Metab Date: 2021-11-30
Authors: Lorenz Schubert; Guenter Russmueller; Heimo Lagler; Selma Tobudic; Elisabeth Heindel; Michael Kundi; Christoph Steininger Journal: Support Care Cancer Date: 2021-06-30 Impact factor: 3.603