Chances are, if you are an American woman over the age of 50, you have had your bone density tested. It is highly likely you’ve had a result that has alarmed you and prompted you to consider treatment options. You are not alone. Although a bone density diagnosis was never an accurate predictor of fracture, it is estimated that it has resulted in more than half the US female population over 65 years (and a good percentage of younger women) being treated with osteoporosis drugs – drugs that offer minimal benefit and pose serious harms.
Now, in 2011, the field of osteoporosis diagnosis is even more of a minefield. Whether you are male or female, new US clinicians’ guidelines greatly increase your likelihood of being labelled at risk. You can go on-line (with or without your physician), fill in a free questionnaire, and presto! – determine your apparent risk of fracture in the next yen years, and whether you need to be treated. Created by the WHO, the Fracture Risk Assessment Tool (FRAX) is the latest of many multiple risk factor tools that have been developed over the years. But this has the added sophistication of easy on-line access. It has been sanctioned and adopted by the US National Osteoporosis Foundation (NOF) and other august bodies. It is currently on a calculator in Japan, a CD in Poland, and is also available as an iPhone or iPad app. The FRAX website has an average 60,000 hits daily.
Accurately determining fracture risk is a science still in it infancy. After all, who can ever really predict who is going to fall and break a hip? The questions in the FRAX calculator cover risk factors including age, gender, weight and height, a previous fracture, a parent with a hip fracture, current tobacco smoking, alcohol consumption, treatment with corticosteroids, long term use of corticosteroids, rheumatoid arthritis and secondary osteoporosis due to factors such as diabetes, thyroid conditions, early menopause and liver disease. Bone density of the neck of femur (hip bone) can be included or not.
On the face of it, it seems like a good move to include a range of factors. But The NOF guidelines based on the FRAX algorithm have drawn wide criticism from within the osteoporosis clinical community, as rather than excluding patients at low risk, they run the risk of casting an even wider net and diagnosing and treating much larger populations than those identified by a BMD diagnosis alone.
The NOF guidelines recommend screening all women over 50 years, and if this target is achieved it is estimated that at least 72% of U.S. white women age 65 years and 93% of those aged 75 year of age would be recommended for drug treatment. Application of the same guidelines to men has similarly estimated that a very large proportion of white men in the United States (At least 34% of US white men aged 65 years and older and 49% of those aged 75 years and older) would be recommended for drug treatment.
FRAX has never been tested on a large population over time, and its algorithm formula revealing how each risk is weighted for calculation has been kept secret. But you certainly don’t have to tick every box to qualify for treatment. Just being female, over 60, and of small build may be enough. And if you have broken your wrist, or one of your elderly parents fell and fractured a hip, you are a likely candidate.
And while the calculator includes tobacco and alcohol use, it doesn’t ask how long or how much a person has been smoking or drinking. The effect of cigarette smoking on bone health is also complicated. Long-term smoking does appear to reduce bone density, but the NIH statement on bone health and smoking observes: “It is hard to determine whether a decrease in bone density is due to smoking itself or to other risk factors common among smokers.”
The current evidence around the influence of alcohol on bone is inconclusive and contradictory. Moderate drinking does not seem to be a significant risk factor for bone loss and osteoporosis.
And the inclusion of a previous fracture as a risk factor is always contentious. How is it determined whether the reported fracture was a result of low impact (a sign of fragility), or the result of an impact under which any bone is likely to break? And the reported fracture could have occurred in bones not related to osteoporosis, such as fingers and toes. There is no discrimination around site.
Factors such as risk of falling, vitamin D levels, measurements of physical activity (particularly weight-bearing exercise) and whether a person’s diet is rich in bone building nutrients like calcium, magnesium, vitamin K etc. have not been included.
If the FRAX website is receiving 60,000 hits a day, we can conclude that the osteoporosis drug industry is in great heart. But when is the safety and the interest of the patient going to be the priority? Once in the diagnostic door it is very hard to find a way out.