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Teriparatide promotes bone healing in medication-related osteonecrosis of the jaw: a placebo-controlled, randomized trial

Research output: Contribution to journalArticle

Ie-Wen Sim, Gelsomina Borromeo, Claudine Tsao, Rita Hardiman, Michael Hofman, Christian Papatziamos Hjelle, Musib Siddique, Gary Cook, John Seymour, Peter Ebeling

Documents

  • ONJ Trial Manuscript-JCO

    ONJ_Trial_Manuscript_JCO.docx, 456 KB, application/vnd.openxmlformats-officedocument.wordprocessingml.document

    Uploaded date:27 Apr 2020

    Version:Submitted manuscript

King's Authors

Abstract

Purpose
Medication-related osteonecrosis of the jaw (MRONJ) is an infrequent, but morbid and potentially serious condition associated with antiresorptive and anti-angiogenic therapies. Although MRONJ can be prevented by optimising oral health, management of established cases is supportive and remains challenging. Teriparatide, an osteoanabolic agent that improves bone healing in pre-clinical studies and in chronic periodontitis, may represent a potential treatment option.
Patients/Methods/Designs
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 (20µg/day) or placebo injections, in addition to calcium and vitamin D supplementation and standard clinical care. Participants were followed for 12 months, with primary outcomes including the clinical and radiological 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 (OR 0.15 vs 0.40, P = 0.013), with 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 = 0.017). The incidence of adverse events was balanced between groups, with most being mild in severity including nausea, anorexia and musculoskeletal pain.
Conclusion
Teriparatide improves the rate of resolution of MRONJ lesions, and represents an efficacious and safe treatment for MRONJ.

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