The Pharmaceutical Benefits Scheme has recently followed the U.S. Food and Drug Administration, and extended the listing for denosumab (Prolia®) to include the treatment of osteoporosis in men who are 70 years or older with a bone mineral density (BMD) T-score of -2.5 or less.

Denosumab is a human monoclonal antibody, which works by inhibiting bone resorption from osteoclasts. It has previously been shown to increase BMD and reduce the risk of vertebral, hip and non-vertebral fractures in postmenopausal women with osteoporosis.

In fact, denosumab offers considerable gains in BMD at skeletal sites when compared with alendronate. Denosumab may also be used for older patients who struggle with the challenging dosing requirements of bisphosphonates and those who have renal dysfunction.

The ADAMO trial compared the efficacy and safety of denosumab, 60mg every six months, against placebo in 242 males with osteoporosis. The result demonstrated that after one year of treatment, men with a low BMD had achieved a statistically significant reduction in bone resorption and an increase in BMD throughout the skeleton.

Please review full product information before prescribing.

References:

  1. Baron R, Ferrari S, Graham R, Russell G. Denosumab and bisphosphonates: different mechanisms of action and effects. Bone 2011; 48(4):677-92.
  2. Diab D, Watts NB. Denosumab in osteoporosis. Expert Opin Drug Saf. 2014; 13(2):247-53.
  3. National Prescribing Service (NPS). Denosumab (Prolia) — listing extended to include men over 70 years with osteoporosis. NPS Radar 2013 Dec 2.
  4. Orwoll E, Teglbjærg CS, Langdahl BL, Chapurlat R, Czerwinski E, Kendler DL. A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density. J Clin Endocrinol Metab. 2012; 97(9):3161-9.
  5. Prolia (denosumab) Australian approved product information. North Ryde: Amgen Australia Pty Ltd. Approved 5 September 2013.

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