Osteoporosis Medications Can Be Fatal

October 13, 2010 — "Bisphosphonates approved for the treatment of osteoporosis will now bear a label warning about the possible increased risk for 2 types of atypical femur fractures, the US Food and Drug Administration (FDA) announced today.

One type of break, subtrochanteric femur fracture, occurs just below the hip joint. Another type, diaphyseal femur fracture, is in the long part of the bone. Both are very uncommon, accounting for less than 1% of all hip and femur fractures overall, according to the agency.

Risedronate sodium, alendronate

The FDA's decision to add a warning about the fractures to the labels of bisphosphonates comes in the wake of a recommendation to do so by a task force of the American Society for Bone and Mineral Research.  In a report released last month, the task force said that of 310 cases of atypical femur fractures under study, 94% of the patients had been taking bisphosphonates, most for more than 5 years. The task force stopped short of declaring that the medications cause the fractures.

The FDA noted today that atypical femur fractures also happen to people not taking bisphosphonates."

Dr. Jacobs' Commentary:

This finding is not surprising as the research on bisphosphonate drugs -such as Boniva, Fosamax and Actonel- clearly show no benefit in reducing bone fractures.  In fact, there has been a trend toward increased bone fractures, despite the fact that these drugs increase bone density, as seen on X-ray density imaging tests. 

Fracture is a major health problem.  Fractures accounted for an estimated $17 billion in health care costs in 2005.  A sharp increase in death following a fracture has been known for some time.  For example, a published 2010 Annals of Internal Medicine meta-analysis paper concluded the following:

"Older adults have a 5- to 8-fold increased risk for all-cause mortality during the first 3 months after hip fracture. Excess annual mortality persists over time for both women and men, but at any given age, excess annual mortality after hip fracture is higher in men than in women."

Most of you will be as surprised as I was to read that even though men and women both have a terrifying increased risk of death following a fracture, men -not women!- were actually more likely to die down the road.  We need to be at least equally concerned with frail elderly men as we are with elderly women.

I am baffled by the backpedaling remark by FDA officials, that atypical femur fractures also occur in people not taking bisphophonates.  The blatant ongoing positive bias the FDA has toward the pharmaceutical industry is epitomized by the selective use of mathematics to down-play a major drug-related health problem. This type of selective mathematics is seen repeatedly in the media, where proponents of conventional medicine and pharmaceutical companies defend their industry and, all-too-often, in also trying to defame complementary and alternative medicine practices.

The article should have stated this: that individuals taking bisphosphonates are almost 16 times more likely to suffer an atypical femur fracture compared to persons not taking the drugs.  A doubling of an adverse health risk is usually considered a major public health issue.  A 16-fold risk increase is an enormous problem! 

The article also failed to reference ongoing major concern regarding bisphophonate-related osteonecrosis (bond death) of the jawbone, for which there is no cure -except prevention by not taking the drugs in the first place!

It appears obvious that there is a serious flaw to the bisphosphonate approach to enhance bone density and reduce fractures.  And the most likely reason because bisphosphonates act to increase bone density via a toxic action on bone cells called osteoclasts.  Osteoclasts are important because they are needed to ensure healthy bone formation and remodeling.  The structural architecture of bone is complex and its design is truly awesome when viewed from a physics and materials strength perspective.  Bisphosphonates interfere with intrinsic architecture, and therefore weaken bones, despite the fact that X-rays prove they make bone denser.  Essentially, bisphosphonate drugs make your bones more like a stick of chalk.  Chalk is dense through-and-through, but it's also brittle and easily snaps in two.

The Osteoporosis Cure

There are proven ways to reverse osteoporosis that are safe, effective and less expensive.  And these "alternatives" are actually healthy for your body!  While it is best to prevent osteoporosis, starting in the teenage years, the most effective way to actually reverse the problem is through diet, nutritional supplementation and corrective hormone replacement therapy. 

Notice that I used the term, corrective, when referring to hormone replacement therapy.  Hormone deficiency states reduce the body's ability to heal, remodel and build bone and other tissues.  Normalizing hormone levels, using bio-identical hormone replacement, nutritional supplements and/or other approaches, supports bone building.  It is absolutely key that you have healthy levels of testosterone, estrogens, growth hormone, and the stress hormones (cortisol and cortisone).

Vitamin K, taken in pharmaceutical dosages not found in over-the-counter supplements, has been proven to be as effective as bisphosphonates at increasing bone density, but without the fracture risk.  The reason is because vitamin K is a nutrient is involved in an essential step in the bone building process.  It appears that high dose vitamin K supplementation supports and accelerates healthy bone mineralization.  High dose vitamin K also appears to have no side effects!  It is for these reason that this approach is a standard medical treatment for osteoporosis in Japan.

Several other nutrients are also vital to optimize bone density and strength.  Nutrient requirements vary from person to person and it is proven that very common genetic variations, lifestyle and dietary factors all influence nutritional needs to stay healthy.  It it best to consult with me to devise an approach that is best suited to address your health needs.

If you or a loved one is taking Actonel, Boniva or Fosamax, then contact my office to schedule an appointment to discuss a safer, more rational approach to reverse and resolve your bone density problem.

Dr. Thaddeus Jacobs Park City & Holladay / Salt Lake City, UT

1881 Prospector Avenue  Park City, UT 84060  435-647-9500

2180 E. 4500 S. suite 185  Holladay, UT 85117  801-277-7000