Aclasta(R) (zoledronic Acid 5mg) Approved In EU To Treat Steroid Induced Osteoporosis In Men And Post-menopausal Women

Main Category: Bones / Orthopaedics
Also Included In: Arthritis / Rheumatology;  Menopause;  Regulatory Affairs / Drug Approvals
Article Date: 02 Jul 2009 - 0:00 PST

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Aclasta® (zoledronic acid 5 mg)[1] has been approved in the European Union to treat men and post-menopausal women with osteoporosis caused by the long-term use of glucocorticoids, commonly known as steroids.1 The new indication for the treatment of glucocorticoid-induced osteoporosis (GIO) is important because glucocorticoids (often referred to as corticosteroids or steroids) are widely used to treat inflammatory conditions such as asthma, rheumatoid arthritis and inflammatory bowel disease. Patients receiving long-term steroid therapy are at increased risk of fracture, as their use is associated with side effects such as bone loss and consequently osteoporosis.3

"Oral bisphosphonates have been used for many years for the treatment of glucocorticoid-induced osteoporosis, but they are associated with poor compliance as patients frequently fail to take them as prescribed," said Professor David M. Reid, Head of the Division of Applied Medicine at the University of Aberdeen, UK. "Available data show that patients who remember to take their medicines only half of the time receive little or no protection 4."

He added: "The approval of Aclasta is a significant step forward for the treatment of glucocorticoid-induced osteoporosis and has the advantage of year long compliance and sustained osteoprotection."

The new indication for glucocorticoid-induced osteoporosis is based on a study published in The Lancet this year.2 These data show that at 12 months of treatment a yearly infusion of zoledronic acid 5mg increases bone mineral density (BMD) at the lumbar spine significantly more than oral risedronate 5mg taken daily (a current established therapy) for the treatment of glucocorticoid-induced osteoporosis (zoledronic acid 4.1%, risedronate 2.7%; P=0.0001).2 The greater efficacy of zoledronic acid 5mg was evident at the lumbar spine at six months after treatment initiation.2

Safety results from this study show that zoledronic acid 5mg is well-tolerated.2 The most common adverse events associated with zoledronic acid 5mg were transient post-dose symptoms such as fever and muscle pain. The majority of these symptoms occurred in the first three days after administration and resolved within that same period of time.2 Post-dose symptoms can be reduced by taking paracetamol or ibuprofen shortly after the zoledronic acid 5mg infusion.1 The frequency of serious adverse events recorded by the investigators was similar between the zoledronic acid and risedronate groups.2 Please see the summary of product characteristics for Aclasta (zoledronic acid 5mg) and Actonel (risedronate 5mg) for a full list of side effects.

"This approval marks another important achievement for Aclasta by adding to the broad spectrum of patients who can now be treated with this therapy," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "Aclasta has a strong efficacy and safety profile built up during eight years of clinical research experience involving 14,000 men and women. Aclasta has now been used in more than 500,000 patients since its launch in 2007 showing that an annual infusion is a valuable treatment option."

Zoledronic acid 5mg is an annual infusion currently used to treat osteoporosis in men and postmenopausal women at increased risk of fracture, including those who have experienced a low trauma hip fracture. It is also indicated for the treatment of Paget's disease of the bone.1

Zoledronic acid, the active ingredient of Aclasta, is also available under the trade-name Zometa® (zoledronic acid 4mg) for use in oncology indications.

The brand name for risedronate 5mg is Actonel and the marketing authorization is held by Proctor & Gamble Pharmaceuticals UK Ltd.5

References

1. Aclasta Summary of Product Characteristics, Novartis Pharmaceuticals UK limited

2. Reid DM, Devogelaer JP, Saag K et al. Zoledronic acid and risedronate in the prevention and treatment of glucocorticoid-induced osteoprosis (HORIZON): a multicentre, double-blind, double-dummy, randomised controlled trial . Lancet 2009: 373:1253-63.

3. Sambrook PN. Corticosteroid Osteoporosis: Practical Implications of Recent Trials. JBMR 2000; 15:1645-1649.

4. Siris SE, Harris ST, Rosen CT et al. Adherence to Bisphosphonate Therapy and Fracture Rates in Osteoporotic. Women: Relationship to Vertebral and Nonvertebral Fractures From 2 US Claims Databases. Mayo Clin Proc. August 2006;81(8):1013-1022.

5. Actonel Summary of Product Characteristics, Procter & Gamble Pharmaceuticals UK Ltd

Source
Novartis