Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Annual infusion for osteoporosis

Zoledronic acid (Aclasta®) has been approved in Europe for the treatment of osteoporosis in post-menopausal women at increased risk of fracture. The summary of product characteristics has been updated to reflect this license extension.

The licence extension has been granted following publication earlier this year of the HORIZON-PFT study in the New England Journal of Medicine. This randomised controlled trial involved 7,765 women who were randomised to an annual infusion of zoledronic acid or placebo and followed up for 3 years.

The results of the study found a 70% relative risk reduction in vertebral fractures and a 41% relative risk reduction in hip fractures in the patients on active treatment. For hip fractures this is equivalent to a Number Needed to Treat (NNT) of 91 over 3 years to prevent one hip fracture. In monetary terms this means investing approximately £77,500 over 3 years to prevent one hip fracture.

There are data to show that compliance with bisphosphonate treatments is poor with some papers noting that half of patients stop taking treatment within the first year. This product may improve compliance by avoiding gastrointestinal side effects and simplifying the dosing regimen.

However, consideration needs to be given to the cost of treatment compared to existing strategies and also to delivery of the infusion. Based on the Drug Tariff price for alendronate 70mg, a year of treatment would cost £50.83 compared to £283.74 for zoledronic acid. A 15 minute infusion may also need to be undertaken in a secondary care setting which would invite an additional charge for service delivery.

Action: Clinicians should pro-actively check and encourage continued compliance in patients prescribed oral bisphosphonates. Zoledronic acid may be an option for patients who are unable to tolerate oral bisphosphonates due to intolerable side effects. Clinicians will need to investigate any local arrangements for administration of the infusion.

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4 Comments to “Annual infusion for osteoporosis”

  1. [...] recent HORIZON study found an unexpected increase in the risk of AF in patients assigned to the study drug. This study [...]

    Pingback by Prescribing Advice For GPs » Bisphosphonates Linked To AF — May 2, 2008 #
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  2. […] recent HORIZON study found an unexpected increase in the risk of AF in patients assigned to the study drug. This study […]

    Pingback by Bisphosphonates Linked To AF | Prescribing Advice For GPs — May 2, 2008 #
    Reply

  3. [...] Update to previous Blog. As reported by Matt Robinson’s Prescribing adviser blog, Zoledronic acid (AclastaR) has been approved in Europe for the treatment of osteoporosis in post-menopausal women at increased risk of fracture. The summary of product characteristics has been updated to reflect this license extension. Prescribers should consider the issues highlighted in the earlier blog article on this product, in the So what? and Action sections. [...]

    Pingback by NPCi Blog » Blog Archive » Zoledronic Acid Now Licensed In UK — October 15, 2007 #
    Reply

  4. [...] Update As reported by Matt Robinson’s Prescribing adviser blog, Zoledronic acid (AclastaR) has been approved in Europe for the treatment of osteoporosis in post-menopausal women at increased risk of fracture. The summary of product characteristics has been updated to reflect this license extension. Prescribers need to consider the issues highlighted under So what? and Action: above. [...]

    Pingback by NPCi Blog » Blog Archive » Annual Bisphosphonate Infusion For Secondary Prevention Of Osteoporotic Fracture Reduces Total Fracture Risk And Death Rate But Not Hip Fracture Risk — October 12, 2007 #
    Reply

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