Recommendations for the Registration of Agents to be Used in the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis: Updated Recommendations from the Group for the Respect of Ethics and Excellence in Science

Registration of new chemical entities to be used in the management of GIOP should be granted, based on a 1-year noninferiority trial, using BMD as primary outcome and alendronate or risedronate as comparator. Demonstration of antifracture efficacy should have been previously demonstrated in PMO.