Evaluation of Zoledronate for Pain Suppression in Diffuse Sclerosing Osteomyelitis of the Mandible: Protocol for a Prospective, Single-Arm Interventional Study.

INTRODUCTION

Diffuse sclerosing osteomyelitis (DSO) is a non-bacterial osteomyelitis that occurs infrequently and is characterized by recurrent severe pain, swelling of the mandible, and trismus. To date, no effective treatment has been established. Bisphosphonates have been suggested as an efficacious treatment for DSO; however, no prospective studies have examined the effect of bisphosphonate treatment in adults with DSO. This study aims to evaluate the effect of zoledronate on pain suppression in patients with DSO.

METHODS

This is a single-center, exploratory, single-arm, prospective interventional study. The participants will include eight patients with DSO of the mandible. The primary endpoint is the change in pain levels before and after zoledronate administration. The secondary endpoints are assessing the efficacy of the clinical course, imaging changes, and safety monitoring. Patients will be enrolled if they are deemed eligible following screening tests and will receive only one 4.0 mg intravenous dose of zoledronate within seven days of enrollment. Study participants will be followed up at one, four, 12, 24, and 48 weeks post-dose or at discontinuation after zoledronate administration.

CONCLUSION

This study is the first prospective trial to evaluate the effect of administering a single dose of zoledronate on pain suppression in patients with DSO. We believe this study will lead to the conclusion that zoledronate is an effective treatment for DSO.