Injection Offers Hope For Brittle Bone Sufferers

Millions of women could be protected against life-threatening hip fractures by a once-a-year treatment with a new drug.

{mosimage}More than 14,000 women die every year in Britain after breaking their hips as a result of the bone-thinning disease osteoporosis, which affects up to three million people. The new treatment cuts the risk of such fractures by more than 40 per cent.

Almost half a million women, mostly aged over 50, are prescribed drugs for the disease. Well-known sufferers include Rosalind Shand, the mother of the Duchess of Cornwall, Elizabeth Taylor and Doris Lessing. the novelist.

The 15-minute treatment means that women can be protected against developing brittle bones without having to remember to take pills regularly. Poor adherence to treatment is a major problem in the development of osteoporosis. The new drug, zoledronic acid (Aclasta) has been tested on almost 8,000 women in a trial that included patients from Aberdeen, Sheffield, Liverpool and Glasgow.

They were given annual infusions of either Aclasta or a placebo, and followed for three years. The results, published in the New England Journal of Medicine, showed a 70 per cent reduction in fractures of the vertebrae of the spine, and a 41 per cent reduction in hip fractures. Breaks elsewhere in the body, such as the wrist, were reduced by 25 per cent.

There are more than 60,000 hip and 120,000 vertebral fractures every year in Britain, according to the National Osteoporosis Society. One in five of those who suffer a hip fracture dies within three months.

Drugs for the disease, including the class called bisphosphonates to which Aclasta belongs, are given normally as pills that are taken daily or weekly. They are effective but do not always achieve their full potential because women stop taking them.

One study in the US of bisphosphonate users who were followed for two years, found that only 43 per cent took the full course prescribed to them.

Professor Dennis Black, of the University of California, who led the new study, and his co-authors concluded: “A regimen of infusions once a year appears to ensure that patients will have a full treatment effect for at least 12 months. In contrast, many patients who receive prescriptions for oral bisphosphonates stop treatment, and most appear to be taking less than 80 per cent of their prescribed pills by 12 months.” The National Osteoporosis Society welcomed this “exciting new treatment”, saying that when it is available, it will add to the choice of drug treatments available for people at risk of breaking a bone due to osteoporosis.

“An annual intravenous preparation may prove to be a convenient, cost-effective strategy,” the society said.

Richard Eastell, Professor of Bone Metabolism at the University of Sheffield and a co-author of the study, said that the findings provided potential good news for thousands of women. “The ability to only have the treatment once a year does mean that it simplifies the whole regimen. There is no doubt that Aclasta reduces vertebral fracture, hip fracture and other breaks,” he said.

David Reid, of the University of Aberdeen and a co-author, said that the hip fracture data was particularly relevant. “Preventing hip fractures remains the holy grail of treating osteoporosis, as we know that six months after a hip fracture, nearly a fifth of patients will be dead. Reducing hip fractures by 41 per cent is therefore highly clinically significant.”

Professor Juliet Compston of Cambridge University, a specialist in osteoporosis, said that the intravenous administration of Aclasta ensured that treatment was delivered correctly. The side-effects of the infusion appeared to be manageable, although Professor Compston was concerned about a rise in atrial fibrillation (a heart rhythm disturbance) in some patients, but this could be due to chance, she said.

Aclasta is made by Novartis, which funded the study. It is currently licensed for use in Britain in the treatment of Paget’s disease of the bone, and a 100ml infusion containing 5mg of the drug (the dose in the trial) costs the NHS £284.