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Denosumab (Prolia) treatment and the COVID-19 pandemic

Information to help healthcare professionals manage osteoporosis patients taking denosumab (Prolia), during the COVID-19 pandemic.

Continuing denosumab treatment is important

Denosumab treatment should be continued through the COVID-19 pandemic.

This need has been highlighted in COVID-19 guidance from both NHSE and NICE. And we're sharing this advice with our beneficiaries.

The offset of treatment effect is very rapid, resulting in accelerated bone loss and an increased risk of 'rebound' fracture:

  • BMD decreases to pre-treatment baseline within 12 months
  • Rebound has been associated with the rapid occurrence of multiple vertebral fractures
  • Offset occurs if treatment is delayed by as little as four weeks, ie. more than seven months after previous injection

Risk of fracture vs. COVID-19 exposure

The increased risk of fracture if treatment is delayed needs to be balanced against the risk of COVID-19 exposure.

Current circumstances dictate the need for pragmatic decisions to be made. As far as possible, these should be based on the individual patient’s circumstances and wishes.

It's particularly important to continue timely treatment in patients meeting one or more of these criteria:

  • Longer duration of denosumab treatment (treatment for less than two years is associated with low risk)
  • History of hip and/or vertebral fracture
  • Lower baseline BMD (BMD will decrease back to this level within 12 months)
  • Greater increase in BMD since initiation of treatment (this predicts the magnitude of bone loss within 12 months and accelerated bone loss is an independent risk for fracture)
  • Concomitant disease/medication increasing fracture risk eg. glucocorticoids, aromatase inhibitors (effects may be dose-dependent)

The pre-treatment calcium check may be omitted for individuals at low risk of hypocalcaemia.

Low-risk patients

  • Have previously received treatment with denosumab on two or more occasions without clinical or biochemical evidence of hypocalcaemia pre- or post-treatment
  • Are taking their usual calcium or vitamin D supplements regularly
  • Have adequate and stable renal function, ie. CKD G1-3a
  • Have no new comorbidities or medications since previous injection that are likely to affect renal function or calcium handling

If the pre-treatment blood test is omitted, apply these precautions to reduce risk of hypocalcaemia:

  • Ensure dietary and supplemental calcium equates to at least 1000mg a day
  • Ensure the patient takes at least 800IU colecalciferol a day (a higher dose may be needed in obese patients)
  • An additional bolus of oral vitamin D a week, or two prior to injection e.g. oral colecalciferol 20,000IU
  • Where feasible, a blood sample to check calcium and creatinine, at the time of injection

High-risk patients

If the patient has CKD 3b or worse, they are at high risk of hypocalcaemia.

These patients:

  • Should be managed within or in conjunction with secondary care services
  • Require the pre-treatment calcium check
  • In many cases, also require post-treatment blood monitoring
  • Are unlikely to benefit from higher doses of colecalciferol (because of the inability to undertake renal hydroxylation of 25(OH)-vitamin D to the active form)

If pre-treatment blood test is considered necessary, local facilities may be available for minimal contact blood tests. For example:

  • Domiciliary phlebotomy
  • Drive-through service
  • Domiciliary administration by primary care or homecare clinician
  • Administration in primary care facility (GP or local pharmacy)
  • Self-administration by patient or a family member/carer supported by their healthcare provider and/or the manufacturer’s, Amgen, Prolong patient support programme
  • Administration in secondary care following stringent infection control measures

The risk of fracture can be minimised by:

  1. Considering use of an alternative anti-resorptive agent to attenuate bone loss (providing no contra-indications), for example:
    • Buffered effervescent alendronic acid (Binosto) for patients unable to tolerate the generic tablet form of treatment
    • Weekly oral risedronate or monthly oral ibandronate may be tolerated by patients intolerant of alendronic acid
    • Raloxifene
    • Strontium ranelate 
  2. Encouraging the patient to continue taking supplements of calcium and vitamin D
  3. Considering strategies to reduce falls risk
  4. Ensuring denosumab treatment is rearranged as soon as possible

Key messages for patients

  • Denosumab (Prolia) treatment wears off very quickly, so it's important that you continue to have your treatment on time every six months. If your treatment is delayed, your risk of breaking a bone may increase very quickly.
  • Denosumab is an antibody-based medication, but it doesn't suppress your immune system. This means it doesn't increase your risk of complications from the coronavirus. This is unlike other antibody-based medications used to treat diseases like rheumatoid arthritis.
  • The clinical team looking after your osteoporosis has put measures in place to ensure you can continue to receive your treatment safely
  • Please continue to take your usual supplements of calcium and/or vitamin D
  • Please discuss any concerns about your treatment with your clinical team
  • Speak to a specialist nurse on the Royal Osteoporosis Society’s free Helpline: 0808 800 0035 or nurses@theros.org.uk
  • Find out more about managing your osteoporosis during the pandemic on the Royal Osteoporosis Society's website: https://theros.org.uk/coronavirus