NICE guidance - denosumab

• denosumab is a monoclonal antibody that reduces osteoclast activity, and so reduces bone breakdown
  • denosumab has a UK marketing authorisation for the treatment of osteoporosis in postmenopausal women at increased risk of fractures
  • the summary of product characteristics states in the indication that denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures

NICE state (1):

• denosumab is recommended as a treatment option for the primary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures:
  • who are unable to comply with the special instructions for administering alendronate and either risedronate or etidronate, or have an intolerance of, or a contraindication to, those treatments and
  • who have a combination of T-score, age and number of independent clinical risk factors for fracture as indicated in the following table:

• denosumab is recommended as a treatment option for the secondary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures who are unable to comply with the special instructions for administering alendronate and either risedronate or etidronate, or have an intolerance of, or a contraindication to, those treatments
• people currently receiving denosumab for the primary or secondary prevention of osteoporotic fragility fractures who do not meet the criteria specified in recommendations should have the option to continue treatment until they and their clinician consider it appropriate to stop

For full details then consult the NICE guidance (1).

Notes:

• denosumab 120mg has also been associated with high levels of calcium in the blood (hypercalcaemia) after stopping treatment (rebound hypercalcaemia) in patients with giant cell tumour of bone (2)
  • denosumab 60mg (Prolia) is not licensed for use in children and adolescents
    • should not be used in children and adolescents younger than 18 years because of safety concerns about serious hypercalcaemia

Reference:

• 1) NICE (October 2010).Denosumab for the prevention of osteoporotic fractures in postmenopausal women
• 2) Drug Safety Update volume 15, issue 10: May 2022: 1.