Denosumab

Question 1

What is denosumab and how does it work?

Answer 1

Denosumab is a human monoclonal antibody that inhibits RANKL, preventing the development of osteoclasts and therefore reducing bone resorption.

Question 2

How is denosumab administered for osteoporosis?

Answer 2

It is given as a 60 mg subcutaneous injection every 6 months.

Question 3

What higher-dose regimen of denosumab is used in cancer patients?

Answer 3

A 120 mg subcutaneous dose every 4 weeks is used to prevent skeletal-related events, such as pathological fractures, in patients with bone metastases from solid tumours.

Question 4

Where does denosumab fit in the management of osteoporosis?

Answer 4

Oral bisphosphonates, particularly alendronate, remain first-line. If alendronate is not tolerated, risedronate or etidronate are recommended. Denosumab may be considered later in the pathway when specific T-score and risk criteria are met, especially as strontium ranelate use declines due to safety concerns.

Question 5

What are the most common side effects of denosumab?

Answer 5

Dyspnoea and diarrhoea, each occurring in around 1 in 10 patients.

Question 6

What other less common side effects are associated with denosumab?

Answer 6

Hypocalcaemia and upper respiratory tract infections.

Question 7

What important safety concern has been highlighted regarding denosumab?

Answer 7

Cases of atypical femoral fractures have been reported. Clinicians should be alert to unusual thigh, hip, or groin pain.