Denosumab is a relatively new treatment for osteoporosis. It is given subcutaneously.

Oral bisphosphonates are still given first-line, with oral alendronate being the first-line treatment. If alendronate is not tolerated then NICE recommend using an alternative bisphosphonate - either risedronate or etidronate. Following this the advice becomes more complicated with the next-line medications only being started if certain T score and other risk factor criteria being met. Raloxifene and strontium ranelate were recommended as next-line drugs in the NICE criteria but following recent safety concerns regarding strontium ranelate it is likely there will be an increasing role for denosumab.


  • Osteoporosis
  • Prevention of skeletal-related events (i.e. pathological fractures) in adults with bone metastases from solid tumours.

Adverse effects

Denosumab is generally well tolerated. Dyspnoea and diarrhoea are generally considered the two most common side effects, occuring in around 1 in 10 patients. Other less common side effects include hypocalcaemia and upper respiratory tract infections.

What does the Drug Safety Update add?

Cases of atypical femoral fractures have been noted in patients taking denosumab. Doctors are advised to look out for patients complaining of unusual thigh, hip or groin pain.