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Archive for the ‘OSTEOPOROSIS’ Category

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.
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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.

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A sensation was created in osteoporosis research circles recently (Nov 26 2008) when a report published in Cell revealed that serotonin made by the gut appears to control bone formation. Osteoporosis authorities expressed surprised at the development which the investigators hail as a breakthrough that could lead to a new and very different treatment. The preliminary research was conducted on mice that were engineered to have human genes.

Ninety-five percent of serotonin in the body is produced in the gut and only 5 percent in the brain. The discovery is linked to a gene called LRP5 which controls an enzyme that converts the amino acid tryptophan to serotonin in the gut. The new research indicates that high levels of gut serotonin inhibit bone growth, and lowered levels of serotonin make bone denser.

The serotonin link to bone strength was identified in children with a rare condition of very weak bones and in people with extremely dense jaw bones. These conditions were found to be due to mutations of the gene LRP5 which in turn either impaired or increased bone formation. The projection from the discovery is that a drug may be created that reduces serotonin production in the gut thereby stimulating bone growth.

As exciting as it sounds, the information may not alter what we know about age-related osteoporosis as the investigators found osteoporosis patients tend to have normal serotonin levels. And in the trial, animals with normal genes that were fed a tryptophan deficient diet didn’t grown denser bones. Time will tell whether this apparent ‘breakthrough’ will translate into a safe and effective new treatment.  Read more…

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The Osteoporosis Story: Broken Bones or Broken System  examines the historical 1992 redefining of osteoporosis, the multi-billion dollar drug and device industry that burgeoned in the wake of the new definition, and the untold numbers of adverse health events that occurred as a consequence.  The documentary covers the essentials on bone metabolism, details the serious limitations and risks of past and current osteoporosis drug therapies, and questions how ‘evidence-based’ medicine can favour profit before patient safety.  It includes women’s stories on the debilitating effects that bisphosphonate drugs like Fosamax have had on their lives; along with Swedish, Canadian, Georgetown, Harvard  and UCLA physicians’ views on the over-selling of the disease, and comments by leading medical authorities and health activists on the woeful state of much of the science behind the osteoporosis ‘epidemic’ and medicine in general. The Osteoporosis Story was written and directed by Ross Johnston and produced by JPL Productions Dunedin New Zealand.  It can be purchased on line at www.theosteoporosisstory.com

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A National Women’s Health Network article  Bone-Breaking Drugs? reports on the sudden increased incidence of unusual and serious fractures of the femur (thigh bone) in women taking Fosamax (alendronate) for more than four years.  A  Medline search revealing more than 50 reported cases suggests an epidemic of such fractures say the authors Adriane Fugh-Berman and Charlea T. Massion, as reported cases usually tend to be the tip of the iceberg.

 Reports of serious adverse reactions to bisphosphonate drugs continue to accumulate, indicating they may be doing far more harm than previously thought.  Jaw necrosis and other bone necrosis (bone death) is associated with bisphosphonate use and many dentists now won’t work on orthodontic problems in people on bisphosphonates  as even without osteonecrosis of the jaw,  there is an overall impairment of bone repair mechanisms. Earlier this year the FDA issued an alert regarding chronic and debilitating joint bone and muscle pain. And recently, after examining the evidence the FDA has not been able to confirm that the drugs cause irregular heart rhythms (atrial fibrilliation), but can’t rule it out, either. The FDA says it will do further studies of this issue, but in the meantime it has alerted women about the possible problem. 

A 2006 literature review published in Drug Safety concluded that the underreporting by US physicians of adverse drug reactions including serious and fatal adverse drug reactions is in excess of 90 percent.  Astonishing!  If you or someone in your family has experienced a serious reaction to a bisphosphonate drug or any medical product, you can now report directly to the US Food and Drug Administration MedWatch program by going to the MedWatch homepage clicking on “How to Report”, then “Reporting by Health Professionals” or “Reporting by Consumers”. Or you can report your adverse experience directly to the MedWatch Program by calling call 1-800-FDA-1088.

 

There are also consumer websites like  http://www.askapatient.com or http://www.topix.com/forum/drug/ where you can read others experiences, ask questions and discuss your concerns.

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Hard on the heels of the FDA’s January 2008 alert about serious joint bone and muscle pain associated with the bisphosphonates, comes a worrying series of reports of spontaneous fracturing of the femur (thigh bone) in women who have taken Fosamax for several years.

There have long been concerns that the bisphosphonate action of suppressing bone turnover may cause bone to deteriorate in strength and become more brittle over time. It would seem that those fears are being realized and although still small, the number of spontaneous fractures is prompting an FDA investigation of the phenomenon. Reports from Singapore, Hong Kong and the US all have a similar story to tell: the thighbones of women patients on Fosamax for five years or more have simply snapped while they were walking or standing. Some individuals experienced hip and thigh pain leading up to the event, and others had no warning whatsoever. Biopsies after fracture have shown severely depressed bone formation. (more…)

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Emerging serious risks now make calcium supplementation an unwise choice. A five year Auckland University study was recently halted upon finding that supplementing with 1000mg of calcium a day increased the incidence of heart attack by 40 percent in women over 70 years. More

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 A staggering 84,354 New Zealanders are predicted to break bones this year as a result of osteoporosis; that’s one osteoporosis related fracture every six minutes and a hip fracture every two hours. By 2020 the annual osteoporosis-related fracture rates are expected to exceed 115,000. So cautions the Fonterra funded ‘Burden of Osteoporosis in New Zealand Report’ commissioned by Osteoporosis New Zealand. But should we really heed the exhortations to drink more milk, scoff calcium supplements, have our bones scanned or swallow powerful drugs? (more…)

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