Denosumab – Increased risk of vertebral fractures

Increased risk of vertebral fractures was observed after stopping or delaying ongoing treatment with Denosumab.

Denosumab 60mg (Prolia) is indicated for the treatment of osteoporosis and bone loss. The Commission on Human Medicines’ Pharmacovigilance Expert Advisory Group has considered EU and worldwide safety data, together with data submitted by the manufacturer, suggesting an increased risk of multiple vertebral fractures after stopping denosumab for osteoporosis, alongside national and international clinical guidance advising of the potential risk on treatment cessation.

Between 1 January 2015 and 31 December 2019, approximately 396,000 denosumab 60mg pre-filled syringes were dispensed in the UK, making the estimated UK exposure in this time about 197,000 patient-years.3

Since 2015 and up to and including June 2020, 44 cases of vertebral fracture, including multiple fractures, have been reported in the UK in post-marketing settings in patients after stopping or delaying ongoing treatment with denosumab (Prolia). Where reported, these fractures occurred within 18 months of stopping or delaying denosumab treatment, with some in the first 9 months. These fractures were described as life-changing in some cases.