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Around 1.5 million hip fractures occur worldwide each year, many of them in older women. (Rosanne Olsen/ Getty)

Pharmaceutical products and supplements widely used to manage osteoporosis have been slammed by two recent studies, with researchers citing industry links as the reason advocacy groups continue to support such treatments. Wendy Zukerman reports.

In a paper published in the British Medical Journal, Grey and his colleague, Mark Bollard, argue that calcium and vitamin D supplements, which are widely recommended to protect aging bones against breaking, are ineffective.

‘Calcium by itself that’s as a tablet supplement slightly decreases fracture risk, but that benefit is balanced by a number of harms, so that overall there is no net benefit. And vitamin D by itself just doesn’t have any benefit.’

Meanwhile in a separate article also published in the BMJ, Dr Barbara Mintzes from the University of Sydney and her colleagues argue that prescription medications called bisphosphonates widely used to treat osteoporosis are overprescribed. The findings are controversial and have come under fire from several organisations, including Osteoporosis Australia, who describe Mintzes’ claims as ‘sensationalist and not based on fact’. ‘As we age our bones become thinner,’ says Mintzes.

Consequently, the risk of a fracture increases as we get older and injuries can result in disability and even death. Currently, over 2.2 million Australiansare affected by osteoporosis.

Supplementing with calcium and vitamin D which in natural form play an important role in bone health has been promoted as a way of staving off the condition.

Grey estimates that US sales of calcium supplements in 2013 were around US$6 billion, and those of vitamin D around US$748 million in 2012. While not all of those sales are for osteoporosis management, Grey says ‘very large numbers of mostly older women’ have been recommended the supplements.

Calcium and vitamin D intake should not have been recommended

According to Grey, in 2002 studies began showing that calcium and vitamin D supplements do not reduce the risk of fractures. By 2007, the researchers wrote, enough evidence had accumulated ‘that increased calcium and vitamin D intake should not have been recommended for older adults living independently’. And, says Grey, the amount of evidence has only grown since.

By the end of 2010, 14 large randomised trials with over 1,
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000 people, had been published looking into calcium and vitamin D supplementation. According to Grey and Bollard, three of those papers reported that supplements reduced fracture risk, nine showed no effect, and two reported that the products increased fracture risk.

Many influential advocacy groups worldwide continue to recommend calcium and vitamin D supplementation, however. The US National Osteoporosis Foundation (NOF), for example, states on their website: ‘If you have osteoporosis and also have a vitamin D deficiency, your healthcare provider may temporarily prescribe a higher dose of vitamin D.’ The Europe based International Osteoporosis Foundation (IOF) likewise has not changed their policy statements to reflect the accumulating evidence, says Grey.

Osteoporosis Australia recommends calcium and vitamin D supplements for those who are deficient, but does not specifically promote a blanket use of the products for all individuals at risk of the disease.

Part of the dispute may be about who precisely should be taking the supplements and what is an acceptable level of risk. A statement from Osteoporosis Australia, written by Professor Peter Ebeling, cited a large systematic review which found that for high risk populations elderly people living in institutions taking vitamin D and calcium together could reduce fractures. The review found that nine hip fractures would be avoided for every 1,000 patients using that combination of supplements each year.

The review also calculated that for low riskpopulations what Grey refers to as those living independently taking calcium and vitamin D combined would lead to one less hip fracture per 1,000 older adults taking the supplements per year.

Conflict of Interest

Grey and his colleague argue that a web of corporate sponsorship and vested interests are partly to blame for the confused messaging, and continued recommendation of supplementation. The team calculated that over half of the NOF and IOF’s corporate sponsors ‘are active in nutrition related commercial enterprises’. Last year, Bayer HealthCare aligned with NOF to launch a campaign promoting the pharmaceutical’s calcium supplement for use in older women. Osteoporosis Australia also receives funds from pharmaceutical companies, including GlaxoSmithKline, as well as the supplement company Swisse.

Meanwhile, medications currently used to manage osteoporosis have also come under fire from Dr Barbara Mintzes’ study.

Drugs called bisphosphonates are frequently used in osteoporosis treatment to block the natural breakdown of bone. But the BMJ paper questions the value of these drugs and the screening processes used to prescribe them.

The first bisphosphonate for osteoporosis hit the market in the mid 1990s, and their use has escalated rapidly. According to the study, the amount spent on bisphosphonates tripled between 2001 and 2008, and is forecast to exceed $11 billion in 2015.

Before the late 1980s, osteoporosis was usually diagnosed following a bone fracture. But with the advent of technology that allowed doctors to measure the mineral density of bones, the diagnostic criteria for osteoporosis changed. It was hoped that by using mineral density, doctors could diagnose osteoporosis earlier and find ways to prevent fractures.

As a consequence of the new diagnostic criteria, however, more people mostly women were diagnosed with osteoporosis and, despite not having broken bones, placed on medication.
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