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Fosamax and breast cancer

Last December, many news outlets were reporting the latest finding to come from the 2002 Women’s Health Initiative in articles that trumpeted the finding that women who were taking Fosamax and other bisphosphonates for their bones had 32% fewer breast cancers than women who weren’t. At first blush, the idea that you could prevent two of the most frightening conditions that affect post-menopausal women — osteoporosis and breast cancer — with a single medication would seem to be a breakthrough of tremendous importance. I wanted to know more. So I looked at what little information is available about the study — there’s not very much, just an abstract from the meeting where the study was presented and various news reports — and consulted with Dr. Dixie Mills, Medical Director of the Dr. Susan Love Research Foundation, to make sure I understood clearly what the findings meant.

My findings only confirmed my initial suspicions that popular media outlets were blowing the significance of this study out of proportion. I’d like to caution women not to take the headlines at face value. Why? For four reasons:

1. First, bisphosphonates like Fosamax, Actonel, and Boniva stop the activity of bone-building osteoblasts, which I feel (and science supports) could, over time, make bone brittle and more prone to fracture. Unless you’re at very high risk for breast cancer, trading lower risk of breast cancer for the risk of hip fracture would just not be helpful.

2. The information in the study wasn’t part of a clinical trial — it was drawn from the Women’s Health Initiative, which was never intended to study whether osteoporosis drugs affect breast cancer rates. “Observational” data like this is never as meaningful as data from a well-designed double-blind, randomized clinical trial because there is no way to make sure you’re comparing people and circumstances that are fundamentally alike. It’s as though you’re talking about “citrus fruit” without being able to say whether you’re looking at oranges, grapefruits, lemons, or limes!

3. Even if it’s true that these drugs have the happy side effect of limiting breast cancer it doesn’t change the fact that they also have many other unhappy side effects that make them very difficult, if not impossible, for women to tolerate. These side effects include serious digestive disorders and the increased risk of esophageal cancer.

4. The finding reported in the news consisted of “relative risk” data — that is, they compared the risk statistic of women on the drugs who got cancer to the risk of women not taking drugs who got cancer. This approach obscures the fact that in absolute terms, if you treated 100 women for 10 years with these drugs, you’d prevent only 1 incidence of breast cancer — and statistically speaking, that’s a lot of cost to women’s health, both physical AND financial, for a very small benefit!

5. Finally, as Dr. Mills pointed out, along with the decrease in invasive cancer that was so broadly discussed in the media was a less widely reported increase in the incidence of ductal carcinoma in situ (DCIS), a non-invasive, milder form of cancer that is nevertheless an important health concern for women.

All of these factors mean that this study’s findings really are very weak, so until someone undertakes a large, well-designed clinical trial that shows the same results, I think the hoopla is a bit premature.

I know there are better ways — natural ways — that women can both improve bone health and lower their risk of cancer of any kind (not just breast cancer) than using bisphosphonates. Here are four areas you can explore if you want to know more:

 

• Look into getting your Vitamin D status checked. Vitamin D plays a multitude of roles in our health, including helping us maintain strong bones and cancer prevention.

• Learn more about chronic inflammation, which has been implicated in a wide range of health problems — including some forms of cancer.

• Eat an alkaline diet rich in vegetables and fruits, which offer a range of cancer-fighting and –preventing antioxidants.

• Obtain all the 20 key bone building nutrients in adequate doses. All of these nutrients also help build and maintain immune strength.

 

References:

Bankhead C. SABCS: More evidence that bisphosphonates prevent breast cancer. Medpage Today, December 10, 2009.

Chlebowski RT, Chen Z, Cauley JA, et al. 2009. Oral bisphosphonate and breast cancer: Prospective results from the Women's Health Initiative (WHI) (abstract). Paper presented at the San Antonio Breast Cancer Symposium, December 10, 2009, San Antonio, TX.

 

We created the Osteo Blast blog as our forum to express opinions and educate the public about natural means of supporting and improving bone health and overall wellness. As part of this forum, we sometimes discuss medical issues and medications, and their effects on bone health in general. However, we cannot advise readers about specific medical issues in this forum. If you wish to obtain advice from Susan E. Brown, PhD, about your specific bone health and nutritional concerns, please visit our Consultations page. Other specific medical questions should be referred to your healthcare provider.

Comments

February 9. 2010 11:01

I am 66 years old and am also 49 years post gastrectomy.  I suffer from malabsorption & can not take the different bone building medications.  The Dr.s did convince me to take Reclast a year ago.  NEVER again as I had almost all of the side effects.  Scary....I am taking 5,000 units of Vit D and calcium and have been on the estraderm patch for many years.  My osteoporosis has improved to osteopenia in the hips and getting better in the spine too. My mother had severe osteoporosis and in the clinical trials for fosamax.  She got the real stuff but after 10 years they took her off as it was not doing her any good.  Your articles have made it easier to keep learning more.

Jeanette Bossaller

February 9. 2010 11:02

Thank you Dr. Susan Brown for this excellent look at a report which, as you noted, could get women excited and hopeful about its purported results.
As noted, a key finding is that information from the study was not part of the intended clinical trial, and thus, among other shortcomings, certain variables that would have been taken into account were not. I call this piggy backing on an excellent study, the Womens' Health Initiative, which brought we women valuable information on womens' health. We are fortunate to have clinicians/scholars like you available to clarify reports that do get peoples' hopes up, especially those people who are at risk.
Thank you.
Sally Oesterling  

Sally Oesterling

February 9. 2010 11:03

Sally, thanks indeed for your thoughful reading and response. Together we will bring about new perpectives in women's health care.  Susan E. Brown

Susan Brown

February 9. 2010 11:03


I have just turned 68 and have been warned by my 30 something doctor that she thinks I am 2.50 bone density. And that I need to go on Forteo immediately. They are even willing to give it to me as is Lilly until I can get on the Medicare D bandwagon.
I have been running for years. I always get out and walk at least half an hour. I live in the mountains, so have to pull hills. I have smallish bones but don't feel like going on such a two year regimen but will if necessary
Also, she has put me on a huge dose of Vitamin D for 15 weeks.
How much is too much Vitamin D?
They are in my multivitamins also
What kind of vitamins should I take?

Glenda Bell

February 9. 2010 11:04

Dear Glenda,
You bring up various interesting points.  (1) The amount of vitamin D prescribed depends on your blood level of the substance. The standard protocol for vitamin D deficiency is to use
50,000 IU of vitamin D a week (which is 7,142 IU a day) for 8 weeks and then retest. (2) I do not know you situation, but Forteo is generally reserved for those who have had serious fractures and where subsequent fractures cannot be prevented by other means. (3)Whenever a physician thinks a person's bone health situation is serious enough to warrant drug therapy, it is certainly serious enough to warrant a full osteoporosis medical work-up.   You might want to take a look at my discussion the standard medical osteoporosis work-up and see if your doctor has done these tests to look for hidden causes of bone loss. http://www.betterbones.com/bonehealth/medicaltestingforosteoporosis.aspx   Best wishes, Susan

Susan Brown

February 9. 2010 11:04

I am 50 years old and been operated in the thyroid in 1996 (complete take away).Yesterday I performed a measurement in the spine right and left hip and I am diagnised with "osteopenia". I am doing exercise 3 times per week, I am eating a balanced diet (milk yogourt, fatty fish, green salads cereals  etc). I was shocked I couldnt imagine this. What you advise me to do. I dont want to take any drug.

Eleni Fountoulaki

February 9. 2010 11:05

Thank you Dr Susan Brown - I was introduced to your website by Dr Liz ipski and am just sooo grateful to her for that.  I have osteoporosis and have been down the Fosamax path.  It is so inspiring to learn that other people have evidence that there real natural ways to deal with this situation.  I really love the way you have so much information available and one article leads to others.  You have made it really so compelling to learn more.

Marg Hobby

February 9. 2010 11:05

Dear Eleni,
Remember, half the women you age will have a bone density in the "osteopenia" range--it does not have to mean that you will fracture, or even that you are at serious risk.  Why not take our fracture risk assessment and see what other risk factors you might have.  Then have your physical do the medical work-up for osteoporosis to see if there are any hidden causes of bone loss.  I describe this work-up here http://www.betterbones.com/bonehealth/medicaltestingforosteoporosis.aspx.
Perhaps you could use this "shocking" news as a window of opportunity motivating you to undertake a complete Bette Bones nutrition and lifestyle program to help you bones.

Susan Brown

February 9. 2010 11:06

Jeanette,
Good work.  Now be sure your doctor has done a full nutrition work-up because your malabsorption may leave you low in many other key bone nutrients.  Check out my 20 Key Bone Nutrients listing and see if you can have these nutrients tested.  Best wishes, Susan

Susan Brown

February 9. 2010 11:06

This is not the first time that research has linked osteoporosis drugs with an improvement in breast cancer. In the early 1990s the early bisphosphonate called Clodronate was shown to decrease breast cancer metastases in a randomized controlled trial.

What's interesting about this alleged new link between aminobisphosphonate use (such as Alendronate [Fosamax], Risedronate [Actonel], Zoledronic Acid and Ibandronate and breast cancer is that usually women with breast cancer have high bone density.

There also is a biochemical-immune link (very complex and I'm unable to clearly explain it) that does suggest fewer cancers or less spread of existing breast cancer in those using bisphosphonates. However, this would not be an appropriate use of a powerful and potentially risky drug if fragility fractures were not a risk for an individual woman.

Susan, thanks for introducing some caution into the discussion of osteoporosis drugs and breast cancer.

Dr. Jerilynn C. Prior

February 11. 2010 14:30

Thank you, Dr. Brown for digging deep on this one. Anything can make a great headline and it's difficult for the average person, or doctor for that matter, to get to the bottom line on most research that is thrown out there for our consumption. Kudos, and much appreciation for the work you do in this field!

Carrie Mayes

February 11. 2010 21:50

Thank you DR Brown. Your books and articles are so very informative. You do not specify which vitamin D is used in the research you talk about.  I thought that only vitamin D3 would improve your bones and other systems as well. What is your opinion of this?  Carol

Carol Rooker

February 12. 2010 10:41

The articles that I read on line a few months back seemed to say that the studies were done with women who took those bone drugs while having chemo-therapy and that they had a slight improvement in the recurrence rate of the breast cancer, but that those given the drug after the chemo did not..from this they extrapolated that fosamax type drugs help with reducing the recurrence of breast cancer-even the company that makes the drugs noted when presenting the findings, that
these drugs have been related to osteo-necrosis (bone death..)etc...

Lynda Hulkower

February 12. 2010 11:14

There are and have been plenty of studies of bone drugs' effects in women who are on or have just completed chemotherapy, because chemo does such horrid things to your bones... but they're not the ones Dr. Brown is talking about in this post. She's talking about data on bone drug use and cancer incidence that were extracted from the Women's Health Initiative, which was focused on women who DIDN'T have cancer (at the start of the trial) and whether they had better cardiovascular health because they were taking HRT. The increase in cancer related to HRT use was the main reason the study was stopped, but this group of researchers went back to the data and determined who had been taking bone drugs during the course of the WHI and looked at how many of those who were got breast cancer vs. how many who weren't. That's where they found that a smaller percentage of women who were on the drugs got cancer than the percentage of women not taking bone drugs. It was really big in the headlines in December because the news outlets were reporting it as "Fosamax prevents breast cancer" which wasn't really what the scientists were saying.

Fenbeast

April 4. 2010 13:26

Dear Dr. Brown: I just happened to read your write up concerning bisphosphonates and noticed that you stated that they stop the activity of osteoblasts. No, they don't, they destroy osteoclasts which prevents the uptake of old bone which effectively prevents proper bone remodeling and leaves older, cheaper, less viable bone as part of the bone matrix resulting in spontaneous fractures and osteonecrosis of the mandible. It would probably be a good idea to correct this error.
Respectfully submitted,

James Cross, D.C.

Dr. James Cross

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