Study title: Bisphosphonate-related osteonecrosis of the jaws: a case-control genetic study
Primary aim: to test the hypothesis that genetic traits associated with thrombophilia and hypofibrinolysis are associated with BP-related osteonecrosis of the jaws.
Secondary aims: (i) To ascertain via wide-screening analysis potential gene variations associated with BP-related osteonecrosis of the jaws; (ii) to ascertain potential serum biomarkers variations with risk of developing BP-related osteonecrosis of the jaws.
Experimental design: case-control genetic study including up to 800 individuals categorized into three groups (A, B, C). Group A (n=200) is the test group which encompasses individuals with of BP-related osteonecrosis of the jaws. Group B (n=300) and C (n=300) are control groups consisting of individuals on BP therapy without osteonecrosis and healthy subjects respectively.
Sample size: sample size has been calculated on the basis of minimum detectable odds ratios for 80%/ 90%/ 95% power at the 5% significance level using an additive model.