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A ground-breaking New Zealand trial has discovered a cheap treatment given only once every five to 10 years can prevent devastating bone fractures in women who have gone through menopause.
The results from the University of Auckland researchers have been published in the New England Journal ofMedicine, the world’s most prestigious medical journal, which has highlighted their importance in an editorial.
Oestrogen levels drop after menopause and this weakens bone density, which can result in painful fractures that lead to disability or even death. About half of women suffer a fracture after they reach menopause.
Currently, only people who are at high risk of fracture - due to combinations of old age, lots of falls, low bone density or previous breaks - are offered one of a variety of medicines that can improve bone density.
About half of women suffer a fracture after they reach menopause. New Kiwi research shows this pain and disability can be prevented using a cheap, widely-available drug. Composite photo / 123rf
A generic drug, zoledronate, was used. This is a proven bisphosphonate medicine that is currently given to people with osteoporosis (when bones become weak and brittle) as an infusion annually or every 18 months, to slow down the cells that break down bone.
The 10-year trial led by Mark Bolland, an associate professor at the University of Auckland’s School of Medicine, used very infrequent infusions of the generic drug, zoledronate. Photo / 123rf.com
Bolland and other researchers wanted to know if very infrequent infusions of the drug - once every five or 10 years - would also prevent fractures and maintain bone mineral density in early postmenopausal women, who were not considered high risk.
Women from 50 to 60 years of age were randomly selected from the Auckland electoral roll and invited to participate in the novel study.
The more than 1000 participants were split into three groups: those who received a 5mg zoledronate infusion at the beginning of the study and again after five years, those who received only one infusion at the start, and a placebo group.
After 10 years, the results showed that both a single infusion of zoledronate and an infusion every five years reduced the risk of vertebral (spinal) fractures by about 41-44%, and all fractures by about 23-30%.
Put another way, if 22 women were treated with a single infusion then after 10 years that would prevent one woman having a vertebral fracture.
“No one has given zoledronate so infrequently before, and I suspect many people will find the results astonishing, because there are very few examples of a medicine having effects that last so long,” Bolland said.
“It really does open, for the first time, the idea that perhaps a 50-something woman could have several infusions in her remaining life, keep her bone density close to the level it was when she started treatment, and dramatically reduce her risk of fracture as she ages.
“The results show that for the first 10 years this approach is effective (and more effective than we could have hoped for) and leaves us optimistic that the benefits of five or 10-yearly zoledronate will continue after that. We are doing an extension study to test this.”
Zoledronate study lead author Associate Professor Mark Bolland from Waipapa Taumata Rau, University of Auckland.
Participants in the trial, which was funded by the Health Research Council, will now be monitored for a further 10 years to test this. The extension will also delve further into what difference receiving an infusion every five or 10 years makes. That currently appears to be marginal, Bolland told the Herald.
“The simplest way of saying it is that five-yearly infusions might be a bit better than 10-yearly, but it’s a ‘might’.”
Zoledronate was chosen after previous research by Bolland and others found its effect on bone health lasted at least five years - much longer than the drug company’s initial recommendation of annual treatment.
The cost of a zoledronate infusion, which can be done at general practices, is about $20 for the drug itself, and anywhere from free to about $150 for administration.
The research focused on women, who, because of menopause, lose bone density about 10-15 years earlier than men.
“But I think there’s no reason to think it wouldn’t work in men. Zoledronate prevents fractures in older men,” Bolland said.
It would take the medical community time to digest the findings, he said.
“I don’t think we should insist that people have treatment. But I think the guidelines should change, and they should say that this is an option for people who are not at high risk but are concerned about having fractures in the future.”
Zoledronate is generally safe, Bolland said, but about one in five people get a flu-like illness for around 24-48 hours after the first dose. His team are doing other studies examining if taking a steroid can eliminate this.
In its editorial on the “important” findings, the New England Journal of Medicine noted that, “patients who are candidates for these strategies may be at low risk individually, but if the strategies are implemented in a large proportion of the population, the number of events that can be avoided - such as fractures - can be large…a very infrequent drug regimen presents a real opportunity”.
Other study authors included Zaynah Nisa, Anna Mellar, Chiara Gasteiger, Veronica Pinel, Borislav Mihov, Sonja Bastin, Andrew Grey, Ian Reid, Greg Gamble and Anne Horne.
