The Pharmaceutical Journal
Vol 279 No 7470 p318
22 September 2007

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Zoledronic acid once yearly after hip fracture improves survival rate

Once yearly infusions of zoledronic acid — started within the three months following repair of a hip fracture — improves survival and reduces the rate of new clinical fractures, a randomised controlled trial shows.

Researchers assigned 2,127 adults with a mean age of 74 years (mostly white women) who had suffered a previous hip fracture to receive annual intravenous infusions of zoledronic acid (5mg) or placebo. All patients received supplemental vitamin D and calcium.

After a median follow-up of 1.9 years, 101 of the 1,054 patients in the zoledronic acid group (9.6 per cent) had died compared with 141 of the 1,057 patients (13.3 per cent) in the placebo group, a reduction of 28 per cent in deaths from any cause in the zoledronic acid group (P=0.01).

This reduction in mortality was accompanied by a reduction in the rate of new clinical fractures. Treatment with zoledronic acid was associated with a secondary fracture rate of 8.6 per cent compared with 13.9 per cent for placebo (5.3 per cent absolute risk reduction, 35 per cent relative risk reduction).

There were no significant differences in the incidence of cardiovascular or renal toxic effects between the two groups. And previous concerns, linking zoledronic acid with atrial fibrillation, osteonecrosis of the jaw and impairment of fracture healing, were not borne out (published online in New England Journal of Medicine on 17 September 2007).

The author of an accompanying editorial comments: “The reduction in fracture incidence and death was striking and clearly establishes the need for pharmacologic intervention in patients who fracture a hip. … Whether other osteoporosis treatments will show similar benefits remains to be seen, but there is no reason to believe that the positive effects on morbidity and mortality are unique to zoledronic acid or bisphosphonates in general.”

Alastair McLellan, consultant endocrinologist, Western Infirmary, Glasgow, and one of the study’s UK investigators, said: “At the moment, throughout the UK, most women with osteoporosis who break their hip do not receive treatment to prevent further fractures. This is regrettable, because the risk of further fractures is greatly increased after a hip fracture.”

The study was supported by Novartis, manufacturer of zoledronic acid. The company said in a statement that it expects zoledronic acid to be available in the UK before the end of the year for the treatment of postmenopausal osteoporosis in women at risk of fracture.