SPC notes that optimal total duration of treatment for osteoporosis has not been established; need for continued treatment should be re-evaluated periodically, particularly after ≥5 years. Also long-term antiresorptive treatment may contribute to an increased risk for adverse outcomes such as osteonecrosis of the jaw (ONJ) and atypical femur fractures due to significant suppression of bone remodelling. The incidence of ONJ was 0.04% at 3 years, 0.06% at 5 years and 0.44% at 10 years of treatment; risk increased with duration of exposure.