Released 30 June 2009

EU approves zoledronic acid for osteoporosis

Zoledronic acid has been approved for the treatment of osteoporosis in the EU.

The drug (brand name Aclasta) is to be offered to patients with the bone-thinning disease who have developed the condition through the use of steroids.

It is known that steroids, prescribed to patients with inflammatory conditions like rheumatoid arthritis, result in bone loss and consequently, osteoporosis.

In previous clinical trials, zoledronic acid has been found to show good results in slowing the rate of bone loss in people with steroid or glucocorticoid-induced osteoporosis (GIO).

The drug, which is administered by a yearly injection, has also proven to be more effective in reducing bone loss than bisphosphonates, a common treatment for the bone-thinning disease.

A study published in the medical journal The Lancet found that zoledronic acid showed better results in improving bone mineral density after six months compared to risedronate treatment.

Professor David Reid of the University of Aberdeen, one of the authors of the study, said: "Oral bisphosphonates have been used for many years for the treatment of glucorticoid-induced osteoporosis, but they are associated with poor compliance as patients frequently fail to take them as prescribed.

"Available data show that patients who remember to take their medicines only half of the time receive little or no protection … Approval of Aclasta is a significant step forward, as it is more effective and faster-acting than a current established therapy for the treatment of glucorticoid-induced osteoporosis and has the advantage of year-long compliance and sustained osteoprotection."

Osteoporosis occurs in both men and women but is most common in women after the menopause, as they experience faster declines in bone mineral density. This is because they no longer have the protective effect of the female sex hormone oestrogen.

The Arthritis Research Campaign is currently running a trial of zoledronic acid to establish its effectiveness in another common bone condition, Paget's disease of bone.



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