From 1 April 2010, zoledronic acid 5 mg (Aclasta) can be prescribed on the PBS as the sole anti-resorptive agent for:

  • osteoporosis in men without hip fracture
  • people with corticosteroid-induced osteoporosis
  • people with symptomatic Paget's disease.1,2

The authority-required listing for zoledronic acid was previously restricted to:

  • women with osteoporosis and any fracture due to minimal trauma
  • women aged > 70 years with a bone mineral density (BMD) T-score of ≤ –3.0
  • men with a hip fracture due to minimal trauma.

(See the NPS RADAR review: Zoledronic acid (Aclasta) for osteoporosis for more information.3)


No longer restricted to men with hip fracture only

The extended PBS listing for osteoporosis allows zoledronic acid to be prescribed for men with any type of minimal trauma fracture and for men aged > 70 years with a BMD T-score of ≤ –3.0. This is similar to the listings for alendronate and risedronate — other PBS-listed bisphosphonates for osteoporosis (see Table 1).4

Table 1 PBS-listed bisphosphonates for osteoporosis, corticosteroid-induced osteoporosis and symptomatic Paget's disease*4
Generic names Brand names PBS listing


Corticosteroid-induced osteoporosis

Symptomatic Paget's disease

Alendronate sodium

Alendro Once Weekly
Fosamax Once Weekly
Fosamax Plus

Disodium etidronate


Disodium pamidronate


Risedronate sodium

Actonel Once-a-month
Actonel Once-a-week
Actonel Combi
Actonel Combi D

Tiludronate disodium


Zoledronic acid


* Streamlined authority listings except for zoledronic acid (which is authority required)
Restricted to when calcitonin has been found to be unsatisfactory due to either lack of efficacy or unacceptable side effects

Corticosteroid-induced osteoporosis

Zoledronic acid may now be prescribed for people on long-term high-dose (≥ 3 months at ≥ 7.5 mg daily prednisolone or equivalent) corticosteroid therapy and with a BMD T-score ≤ –1.5. Until now, risedronate was the only other PBS-listed medicine for corticosteroid-induced osteoporosis (see the NPS RADAR In Brief news item: Risedronate [Actonel and Actonel Once-a-Week] for corticosteroid-induced osteoporosis5 and Box 1 for more information).4 The PBAC recommended extending the listing of zoledronic acid on a cost-minimisation basis — that is, similar efficacy and cost — compared with risedronate. The equi-effective doses for this comparison were zoledronic acid 5 mg once yearly and risedronate 5 mg once daily.1


Symptomatic Paget's disease

This extended PBS listing is similar to those of alendronate, pamidronate, risedronate and tiludronate — the other PBS-listed bisphosphonates for symptomatic Paget's disease (see Box 1).4 The PBAC recommended this listing on a cost-minimisation basis compared with pamidronate. The equi-effective doses for this comparison were 1 infusion of zoledronic acid 5 mg once yearly and 2 infusions of pamidronate 60 mg per year.1