I was offered my choice of bisphosphonates after breaking my shoulder and ended up with a diagnosis of osteoporosis. I initially opted for Reclast, a drug that only requires one dose a year albeit by IV infusion. I made an appointment to get the drug several weeks later. I wanted to have time to research my options. After reading as much as I could during that time, I made an appointment with my bone health specialist to discuss the treatment. We spent 45 minutes discussing the osteoporosis literature. Despite being a physician, trained in endocrinology, and now pretty up-to-date on the treatment, I just could not bring myself to tell her that, yes, I would take the drug in any of its formulations. Why is that?

I am not anti-medication; I take a ton of them for various conditions that I blame on my mother’s side of the family as well as certain of my less than stellar habits. I also understand the seriousness of the disorder, not only because my broken bone hurt like hell, but also because I am aware of the dismal outcomes of people who fall and break their hips or fracture their vertebrae. This is a definitely a serious condition.

I also know that I am probably not going to build stronger bones without some type of treatment. With the exception of taking calcium supplements, I was already doing all of the recommended lifestyle interventions. I started running in my late 20’s and have continued to do weight-bearing exercises until this day. I eat a healthy diet and I have never had to take any of the drugs known to weaken bones. I even took a selective estrogen receptor modifier (SERM) for more than 20 years. Although I was diagnosed with Vitamin D deficiency a few years ago, I have had D3 levels in the normal range since I started taking supplements.

So, my choice was taking bisphosphonates—the current drug of choice for osteoporosis—or taking my chances that I won’t get another fracture.

 

A crisis in the treatment of osteoporosis

A recent editorial (August 2016) in the Journal of Bone and Mineral Research, titled “A Crises in the Treatment of Osteoporosis,” makes it clear that I am not alone in my ambivalence about the current treatment of choice. A study that looked at bisphosphonate use in 22,598 hip fracture patients to prevent additional fractures, found that the use of the drug decreased from a measly 15% in 2004 to an “abysmal” 3% by 2013.

The authors of the editorial are Sundeep Khosla, MD from Mayo Clinic and Elizabeth Shane from Columbia University (the former with no conflicts of interest, the latter with a history of research support from Lilly, Amgen, and Merck, the manufacturer of the most commonly prescribed bisphosphonate, Fosamax). They note that although bisphosphonates are the “most widely-used drugs today to prevent and treat osteoporosis,” serious side effects, such as osteonecrosis of the jaw, atrial fibrillation, and atypical femur fractures, have scared people away from these drugs even though they are rare.

Citing an analysis of three randomized clinical trials of bisphosphonates, the authors point out that it is the relative risk, not absolute risk that needs to be discussed with patients fearful of taking these drugs. Here is what they mean:

  • About 100 fractures (vertebral and nonvertebral) are prevented if 1000 women with osteoporosis are treated with a bisphosphonate for 3 years. The number needed to treat (NNT) is 10. The number needed to treat for statins is 56. The smaller the number, the better. An NNT of 1 means everyone improves with the treatment and no one in the control group gets better.
  • For the 100 fractures prevented by taking bisphosphonates, 0.02 to 1.25 atypical femur fractures occur. The number needed to harm is 800 to 43,300.

To translate this, there is a very good chance patients will benefit from bisphosphonates and a very small chance that they will be harmed.

In addition to fear of the horrific, albeit rare side effects, there is the difficulty taking the drug in oral form. You have to take it on an empty stomach and not lay down or eat for at least a half hour. If you opt for the IV form, you have to get yourself to an infusion clinic to receive it, which is time-consuming and costly.

 

Stoking the fear

Fear is stoked in no small measure by the large number of stories on the Internet. Google “bisphosphonates” and you will almost certainly come across the prolific writings of Vivian Goldschmidt, Founder of The Save Institute (short for “Save Our Bones”). Her website proclaims the Institute provides

“…natural evidence-based solutions [for osteoporosis] that anyone can understand and implement”

The website is loaded with both testimonials, like this one,

“Been on your program one and a half years. my dexa was -4.9 a year ago, went back this year my dexa was -0.7. I am so happy with the exercises and the supplements.”

and “alerts” about bisphosphonates, like these:

  • ALERT: Bisphosphonates Double the Risk Of Esophageal Cancer

  • ALERT: Bisphosphonates Almost Double The Risk Of Vision Loss

  • Alert! Never-Published Study Uncovers How And Why Bisphosphonates Cause Atypical Fractures

The alerts are accompanied by comments from readers that describe horrible side effects all brought on by taking bisphosphonates.

I don’t mean to pick on Save our Bones but the internet is flooded with bad bisphosphonate stories.

 

What’s a patient to do?

I was lucky. I have access to a bone health expert and a PCP, both of whom have been willing to talk me through my bisphosphonate fears. Interestingly, what finally pushed me over to the “take them, you fool” side of the equation was a photo our Social Media Manager Steffie Harner found to accompany my own story on drugs and osteoporosis.

Elderly woman falling down (1500 x 1147) Adobe Stock

The woman in this photo conjured up visions of my much loved strong but shrinking, blue-haired granny. Although she didn’t fall and break her hip, she clearly had osteoporosis at the end of her life. This could have been her…or, it might be me. Although I am an endocrinology-trained physician who has read the recent osteoporosis literature, it took a photo to really bring home to me what the consequences could be for me if I didn’t take the drug that my doctors and most osteoporosis experts recommend.

Patient decision-making in the era of empowered patients is complex and poorly understood. In the old days when doctors were gods, they (we) said it and you did it (or not). But in the internet era, the inputs into the decision-making process have grown exponentially; there is so much to see, read, and listen to. So, who would have guessed that my own informed decision would be so heavily influenced by my emotional response to a photo? This should give pause to all of us who pontificate about patient behavior.


Postscript: I took my first alendronate (generic Fosamax) pill almost a week ago and outside of the inconvenience of having to plan my morning around the dosing, I didn’t feel a thing. Everything’s good…so far.

1 COMMENT

  1. I think that showing a picture of somebody fallen is a classic case of “Stoking the fear” No treatment will keep you from falling, though you might have better odds of keeping your bones if you take drugs that intervene in the natural process. You also might have even better odds if you do weight bearing exercises and pursue the latest nutritional info on supporting the bone rebuilding process (vs, blocking parts of it) but sure, people want pills and docs want easy interventions, and there are products that are being marketed. You somehow dismiss all this with “I run and take calcium and it’s not enough” I would think not. So you conclude, gotta take these drugs are you will get broken bones. Honestly, most at risk will get broken bones anyway sooner or later, whether they take the drug or not. Unless they die of other diseases first.

    I read the published article and question the wording and tone of many of their statements and implications. They act as though current drug treatments have “conquered” the problem when in reality, it has slightly reduced (or delayed) the numbers of fractures. Most will still occur even with the intervention and it is not a cure.

    Maybe I’m wrong, but you (or the information you share here) also seems to play with statistics in the manner that when you state the risks of ONE type of atypical fracture considered to be a “cost” of Biphosphonates, you do not compare apples to apples to indicate what that risk is among the same number treated for the same time to get the benefit. The time frame is not stated, but apparently of the 1000 treated your statistic chooses to ignore “cost” to 900 of them and ONLY consider the “cost” or bad effects from the drug on the 100 who apparently responded to the drug intervention. There is a problem with this lopsided comparison beyond deceptive statistics, including bias on the part of only noting side effect on the selected 100 responders and not the 900 others who also took the drug – with zero benefit. We want to know the “cost” to the whole group needed to treat in order to get benefits for the 10%.

    This is not to conclude that this intervention does not have a reasonable cost/benefit ratio for some or many but simply that this is not an accurate way to portray the reality.

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