Outcomes of Clinical Trials on Osteonecrosis of the Jaw

Abstract

Objective: The purpose of this study was to provide a cross-sectional view of all registered clinical trials enrolling patients with osteonecrosis of the jaw (ONJ). The primary aim was to report predictors of trial completion and publication of results.

Materials and methods: This is a cross-sectional study of ONJ trials registered with ClinicalTrials.gov. For each included entry, trial characteristics and endpoints were recorded. Predictors were enrollment size, etiology, study type, intervention type, sponsor, funding, study locations, number of centers, and specialty of the principal investigator. Outcomes were trial status, publication on PubMed, journal of publication, and length of time between endpoints. Associations between predictors and outcomes were evaluated using chi-square tests and t-tests.

Results: The final sample included 26 trials. Overall, 50% of trials were completed and 69% of completed trials were published. Three out of four terminated trials were suspended due to lack of funding. The median enrollment for completed trials was 149 participants with a mean length of five years. All trials included medication-related osteonecrosis of the jaw (MRONJ) patients and 26% also included osteoradionecrosis of the jaw (ORNJ) patients. The majority of trials were observational (65%), conducted internationally (62%), and involved multiple centers (54%). Published trials had a mean time of 5.9 years between trial start and publication, which was comparable to trial length (p=0.90) and appeared in either dental (44%) or cancer (56%) journals. Completion and publication rates were not significantly increased by industry sponsorship/funding, larger enrollment sizes, or multi-center involvement. Oral and maxillofacial surgery was the most represented dental specialty of principal investigators (56%).

Conclusions: The majority of completed ONJ trials had their results published in a timely manner. Evidence-based investigation of ONJ is a multi-disciplinary and international effort. Among all specialists, oral and maxillofacial surgeons led the most ONJ trials.

Keywords: bisphosphonate-related osteonecrosis of the jaw; bronj; clinical trials; medication-related osteonecrosis of the jaw; mronj; nct; ornj; osteoradionecrosis of the jaw.