Background: Given the gaps in knowledge that exist in relation to risk stratification for osteonecrosis of the jaw (ONJ) amongst patients treated with anti-resorptive agents, there is a high need for an evidence-based measure which would facilitate the identification of those patients at higher risk of ONJ development; particularly, most of the available advice is empirically based.

Objectives: to develop a valid self-administered questionnaire to facilitate risk stratification and risk minimisation of medication related ONJ in osteoporotic patients treated with anti-resorptive agents.

Methods: Development of ONJ risk assessment questionnaire (ONRAQ) followed 5 stages: 1. Review of the literature to Identify the risk factors associated with medication related ONJ. 2. Item pool development: a list of the main risk factors was compiled. Rare or uncommon factors were excluded. 3. A questionnaire was developed. This was based on the idea that the questions should be straight forward and as clear as possible. 4. Pre-testing of the questionnaire. 5. Validation of the questionnaire by comparing the patients answers with their medical records. Patients at risk were advised to seek dental assessment and the dental report was evaluated. The last prescription was reviewed to verify the current medications. 157 patients were invited to participate and were prospectively monitored for 5-years to assess for the incidence of medication related ONJ. Advice was given regarding how to maintain good dental hygiene to prevent dental disease and to ensure that any dental interventions that are considered necessary are carried out as conservative and preservative as possible. Comprehensibility of the model sections was also assessed.

Results: Stages 1 and 2 identified the risk factors chosen for the questionnaire. These risk factors were stratified into 4 sections: Personal, Dental and oral health, current medications and associated comorbidities. Stage 3 led to the development of the 27 items questionnaire. Personal: 3 risk factors (age, elevated BMI and smoking), Dental and oral health (11 risk factors), current medications (3 risk factors) and associated comorbidities (10 risk factors). Analysis of the answers provided by 126 patients, who completed the study, age range 58-82 years revealed that the mean time to answer the questionnaire was 1.9 + 0.153 minutes. The ONRAQ has shown a strong validity when compared to the patients’ data record (range 0.89-0.97). All patients rated the questionnaire as easily comprehensible. Comprehensibility of the various questionnaire sections ranged between 96.1% and 98.2% denoting that all the questions were well understood by the great majority of patients. 11/126 (8.7%) had a dental procedure in the past 6-months, 13/126 (10.3%) were advised to stop smoking. Whereas 20/126 (20.6%) had associated comorbidities. Risk stratification led to the advice to start oral bisphosphonates/ denosumab rather than IV zoledronate for patients at moderate risk (comorbidities, personal, medication). Treatment was postponed till complete healing for those with recent history of invasive dental procedure (high risk). No ONJ was identified after 5-years of follow up.

Conclusion: Results of this questionnaire revealed that the ONRAQ is valid screening questionnaire. It can be implemented, as a risk minimisation measure, in standard practice. The questionnaire was able to identify patients at risk of developing medication related osteonecrosis of the jaw and facilitate the prospective risk management of ONJ.

Disclosure of Interests: None declared.