New Research Casts Doubt on Benefits of Osteoporosis Drugs

Are millions of women putting up with the undesirable side effects of osteoporosis drugs and not getting the hip fracture-preventing benefits that they are hoping for? And, do efforts to improve balance and prevent falls ultimately produce better results when it comes to preventing hip fractures?

This seems to be the conclusion of a new study published in the British Medical Journal by Finnish researcher Teppo Järvinen, a professor at the University of Helsinki, Finland and colleagues.

Most women over the age of 50 are recommended screenings to check for the thinning bones of osteopenia or full-fledged osteoporosis. And, the logic goes, if the thinning of the bones reaches the benchmark set for a diagnosis of osteoporosis, women should be taking drugs to slow the loss of bone mass density (BMD) or, preferably, even increase bone density.

There is only one problem with this, Järvinen and colleagues point out in the paper. While osteoporosis drugs have been shown to increase bone mass density, this doesn’t necessarily translate into fewer hip fractures.

How could this be? Well, fewer than one in three hip fractures are attributable to bone fragility, the researchers note. Fractures are traumatic events triggered by falls; and most falls serious enough to result in a fracture happen in frail older adults.

The simple question, “Do you have impaired balance?” is a better predictor of fractures than osteoporosis, the researchers note. This question can predict about 40% of all hip fractures, whereas osteoporosis predicts less than 30%.

The Risk of Osteoporosis Fractures

The incidence of hip fracture in women rises 44-fold from the age of 55 to 85, and the effect of aging is 11-fold greater than that of reduced bone mineral density. About a third of generally healthy people aged ≥65 fall at least once a year, this proportion increases to a half by age 80.

As a consequence, the researchers note in the study, we are over diagnosing bone fragility, and this in turn leads to overtreatment. Osteoporosis drugs are big business: In the U.S., about 75 percent of white women over the age of 65 are the primary targets for osteoporosis medication marketing. The amount spent on these drugs tripled from 2001 to 2008, and it is forecast to continue growing.

Bisphosphonates, such as Fosamax, are the dominant drugs for fracture prevention. However, while bisphosphonates do increase bone mass density by blocking the resorption process that is part of the natural process of bone metabolism, the evidence that bisphosphonates prevent fractures is weak, according to the researchers.

Our systematic review of the evidence base for bisphosphonates identified 33 randomized controlled trials of sufficient duration (≥ one year) to expect a preventive effect on hip fractures. In 23 trials reporting on hip fracture, 254/17,164 women taking bisphosphonates versus 289/14,080 taking placebo had hip fractures (relative risk 0.68, (95% confidence interval 0.57% to 0.80%); absolute risk reduction 0.57% for hip fracture over three years. Accordingly, 175 women must be treated for three years for each hip fracture prevented.

But the evidence base is fraught with gaps. Although the mean age of patients with hip fracture in Europe is about 80 years, and over 75% of hip fractures occur among people older than 75, only three of the 23 trials in our systematic review included sufficient women over 75 to allow analysis of hip fracture incidence. All failed to show any significant effect on hip fractures in this age group. Counterintuitively, the evidence thus suggests that those most prone to hip fractures do not benefit from bisphosphonate treatment. This discouraging finding was corroborated by a recent randomised trial of single dose zoledronic acid for osteoporosis in frail elderly women.

Hip fractures in elders often lead to permanently reduced mobility, quality of life and an overall decline in health, as well as significant social and medical costs. So while strengthening the bones intuitively makes sense, Järvinen argues, anti-osteoporotic medication may not be the answer to prevent hip fractures.

“The benefit from the drug treatment is marginal at best. It also seems — and this is an interesting detail — that the better the response to the treatment in the study, the more flaws the study had,” Järvinen said. 

“Only three studies have been conducted on subjects 80 years of age or older, and none of them found that the medication prevented hip fractures.” 

A better strategy for combatting hip fractures: Minimize the risk of falls in seniors by encouraging more physical activity, particularly activities such as yoga that improve balance.  If you are a smoker, quitting smoking is one of the best things you can do to reduce your fracture risk.

In a recent study, YogaU’s Dr. Loren Fishman has shown that yoga offers potential bone-building benefits. Add to that the facts that yoga is a great way to improve balance, and yoga is increasingly emerging as a great technique to reduce the risk of falls and fractures as you get older.

“In contrast to osteoporosis drugs, which come with considerable side effects, yoga offers numerous side benefits,” Dr. Fishman notes. “For millions of women worried about thinning bones and wondering whether they should be taking osteoporosis drugs, it’s important to pay attention to these kind of results.”

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