The current emphasis on using prescription drugs to prevent hip fractures in older adults lacks good scientific evidence and is harming more people than it’s helping, according to an article published Tuesday in the BMJ.
“Pharmacotherapy can achieve at best a marginal reduction in hip fractures at the cost of unnecessary psychological harms, serious medical adverse events, and forgone opportunities to have greater impacts on the health of older people,” write the article’s authors, an international group of 11 physicians and researchers. “As such, it is an intellectual fallacy we will live to regret.”
The article is the latest contribution to the BMJ’s “Too Much Medicine” campaign, which has the goal of educating both the public and the medical community on “the threat to human health posed by overdiagnosis and the waste of resources on unnecessary care.”
And, indeed, how the medical community came to adopt its current drug-based approach to the prevention of hip fractures over the past three decades — and how the public has come to accept it as scientific dogma — is an all-too-familiar tale of overdiagnosis, overtreatment and disease fear-mongering.
A need for prevention
As the authors of the article point out, hip fractures are devastating injuries, often leading to severe disability or death. In the United States, more than 250,000 adults aged 65 and older are admitted to hospitals for hip fractures each year, and 95 percent of those injuries are the result of falls, according to the Centers for Disease Control and Prevention (CDC).
One in three American adults who lived independently before fracturing their hip are confined to a nursing home for at least a year after their injury, and one in five dies within a year.
Those statistics do sound scary, particularly since we know that bones become more fragile with age. But here’s the problem: As defined today by bone density tests or risk calculators, bone fragility — or osteoporosis — is not a good predictor of hip fractures.
Broadening the definition
As the authors of the BMJ article point out, until the late 1980s, osteoporosis was diagnosed only after a bone fracture had occurred.
That situation changed when 1) new technology (dual energy absorptiometry) was developed to measure bone mineral density at the spine and hip, and 2) the World Health Organization (WHO) — with the support of the pharmaceutical industry — introduced a new definition of osteoporosis, which was based on low bone mineral density.
That new definition was issued in 1994. A year later, the first drug to prevent hip fractures, a bisphosphonate called alendronate (Fosamax), came on the market.
Sales of Fosamax and other drugs for the treatment of osteoporosis — as well as sales of the devices for measuring bone density — skyrocketed. The amount spent on the drugs alone tripled between 2001 and 2008, and is expected to exceed more than $11 billion in 2015, according to background information in the BMJ paper.
The development of fracture risk assessment tools, such as FRAX (which was created by WHO with heavy funding from the pharmaceutical industry), has helped to feed those sales trends. For, as a 2009 study pointed out, if all white women over the age of 65 in the United States were to undergo a fracture risk assessment based on those tools, at least 72 percent of them — and 93 percent of the women over the age of 75 — would become candidates to receive drug treatment to prevent fractures.
‘A fundamental flaw’
“Estimating absolute fracture risk is intuitively attractive,” write the BMJ authors, “[b]ut it has a fundamental conceptual flaw: fewer than one in three hip fractures are attributable to bone fragility.”
Health efforts should focus on preventing falls in frail, elderly adults, not on giving them — and much younger women — drugs for their bones, the authors stress.
One prevention strategy that has been shown to reduce falls is physical activity. A meta-analysis published in 2013 found that fall-prevention exercise training was associated with a 60 percent reduction in fracture risk among older women — a reduction “comparable to that of drugs tested in idealized situations with highly selected participants,” the authors of the BMJ article point out.
Research has shown, however, that when older adults are told they have osteoporosis, they tend to decrease their daily activities because they become more fearful of breaking their bones.
Gaps and risks
The BMJ article also details how studies that purport to show that bisphosphonates and other drugs used for fracture prevention (including calcium and vitamin D supplements) are “fraught with gaps.” For example, most of the studies involving these medications tend not to involve frail elderly people over the age of 75 — the group most at risk of experiencing a debilitating hip fracture.
Also, very little research has been done on the optimal length of time for taking the drugs. And none of the major clinical trials have involved men.
These drugs are not without risks. In fact, gastrointestinal symptoms, such as nausea, indigestion, heartburn and vomiting, are so common among people taking the drugs that up to 20 percent of them prematurely stop the treatment. Bisphosphonates are also associated with a rare but increased risk of unusual type of fracture of the thighbone and a deterioration of the jawbone.
Refocusing preventive efforts
“Most of the fracture burden arises from uncommon events among people who do not have osteoporosis rather than from common events in the relative few with the condition,” write the BMJ authors.
We should be focusing our resources on reducing those uncommon events — protecting the elderly from falls — not on unnecessary diagnostic tests and treatments, they stress.
You can read the article on the BMJ website.