Denosumab discontinuation and fracture risk: getting the balance right

Abstract

Denosumab is a highly effective therapy for osteoporosis. Since its approval by the Therapeutic Goods Administration (TGA) in 2010, use of denosumab has surged across Australia, delivering substantial fracture‐prevention benefits to tens of thousands of patients. However, stopping denosumab may lead to acute loss of bone with an increased risk of fractures. Increasing awareness of this so‐called ‘rebound phenomenon’ has created fear and concern among consumers and prescribers. A recent TGA safety update in November 2025 has raised further concern regarding the risk of spontaneous vertebral fractures in patients ceasing denosumab. This Viewpoint aims to interpret the latest updates in the context of current evidence, examine why Australia is particularly vulnerable to misinterpretation of these warnings and provide practical guidance to support safe, evidence‐based management of denosumab use in Australian practice.