Zoledronic acid: summary review and side effects profile published on the NPS RADAR

An excerpt of the summary review and side effects profile of Zoledronic acid, published on the australian NPS RADAR:

  • Zoledronic acid is an intravenous bisphosphonate. It is given as a once-yearly infusion for osteoporosis in women with any fracture, and in men with a minimal-trauma hip fracture.
  • Some patients may prefer zoledronic acid to oral therapy for dosing convenience. However, calcium and vitamin D supplements will still need to be taken daily.
  • Oral bisphosphonates should be stopped in patients starting zoledronic acid.
  • Before prescribing zoledronic acid, check if patients have received their first infusion in hospital.
  • Acute-phase reactions, such as fever, myalgia, flu-like illness and headache, frequently occur within 3 days of infusion.
  • Like other bisphosphonates, zoledronic acid may cause hypocalcaemia, and has been associated with serious, often delayed, adverse effects, including renal dysfunction, inflammatory ocular disorders, osteonecrosis of the jaw and possibly atrial fibrillation.

Safety issues

The adverse-effect profile of zoledronic acid is similar to that of oral bisphosphonates. However, it is important to note that for zoledronic acid:

  • infusion-related acute-phase reactions are common
  • serious oesophageal adverse effects are not expected
  • it is not known if the risk of osteonecrosis of the jaw differs from that with oral bisphosphonates in people treated for osteoporosis.

Like other bisphosphonates, zoledronic acid may cause hypocalcaemia, and has been associated with serious, and often delayed, adverse effects, including renal dysfunction, inflammatory ocular disorders, osteonecrosis of the jaw and possibly atrial fibrillation.2–6 Hypersensitivity reactions have been reported post marketing, including bronchoconstriction, urticaria, angioedema and anaphylaxis.

There is currently limited experience with zoledronic acid in people with osteoporosis. Most safety data are from use at higher doses for malignancy.

Source: NPS RADAR. Zoledronic acid (Aclasta) for osteoporosis after fracture

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