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

TL;DR

This study will test if zoledronate can reduce pain in patients with a rare bone condition called diffuse sclerosing osteomyelitis.

Contribution

This is the first prospective study to evaluate zoledronate's effect on pain suppression in diffuse sclerosing osteomyelitis.

Findings

The study will measure changes in pain levels before and after zoledronate administration.

Secondary outcomes include clinical course efficacy, imaging changes, and safety monitoring.

Participants will receive a single zoledronate dose and be followed for up to 48 weeks.

Abstract

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.

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