NICE guidance - denosumab

Last edited 05/2022 and last reviewed 06/2022

  • 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:
      • Age (years) 0 independent risk factors for fracture 1 independent risk factors for fracture 2 or more independent risk factors for fracture
        60-69 -a -4.5 -4.0
        70-74 - 4.5 -4.0 -3.5
        75 or older -4.0 -4.0 -3.0

        Notes:

        • For the purposes of this guidance, independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of 4 or more units per day, and rheumatoid arthritis.
        • -a denosumab is not indicated

        • T-score measures bone mineral density using central (hip and/or spine) dual-energy X-ray (DXA) scanning, and is expressed as the number of standard deviations (SD) below peak bone mineral density

  • 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:

Related pages:

osteoporosis