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Strange fractures with bisphosphonates

In a few weeks, I’ll be heading off to Toronto for the annual meeting of the American Society of Bone and Mineral Research (ASBMR). And this October, we’ll have a lot to talk about. ASBMR recently convened an expert task force to investigate atypical femur fractures among patients taking bisphosphonates. Their results — published this September — confirm the link between long term use of the popular bisphosphonate drugs and atypical fractures of the thigh.

In 94% of the 310 cases studied by the task force, the individuals had been using bisphosphonate drugs, and most of them had been on the drug for more than five years.

While many of these serious fractures occurred without warning, more than half of the people studied reported groin or thigh pain for a period of weeks or months before the fracture occurred. And to top it off, one quarter of patients who experienced such an atypical femur fracture in one leg experienced a fracture in the other leg as well.  Even though this fractures represent only 1% of all hip fractures, the task force found the issue serious enough to warrant rather strong recommendations.

The ASBMR task force recommends the following:

  • That the FDA require bisphosphonate drugs be labeled to inform people about the possibility of serious atypical femur fractures and the associated warning signs
  • That health professionals should reserve bisphosphonates for patients with certain cancers, Paget’s disease of bone, and patients with osteoporosis who are high risk of fracture

Bisphosphonate drugs include: Aclasta, Actonel, Aredia, Bondronat, Boniva, Didronel, Fosamax, Fosavance, Reclast, Skelid and Zometa. 

For more on bisphosphonates and natural alternatives, read my article on drug therapy for osteoporosis.

Read the full text of the ASBMR task force report.

 

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

September 27. 2010 07:41

I have been diagnosed -2.8 in my hip.  I have read that DHEA and progesterine creams are good for osteoporosis.  I haven't read anything on your website about this.  What do you think? Love your website!. Thank you.

Janet Mabin

September 27. 2010 18:31

I would like to report a fracture such as has been described in the ASBMR task force report. I have reported it to FDA's MedWatch as well, but am trying to reach as many medical professionals as possible, and the at-risk community as well. In Octobor 2009, I began having pain in my right thigh. When I reported it to my doctor, he first suspected that it might be a drug reaction to other medications I was taking. Over several weeks, that cause was eliminated, an x-ray was taken, and finally an MRI in January 2010. The diagnosis was a stress fracture in the upper right femur. One week later, February 3, 2010, I got up from my kitchen table, turned, my leg gave way and I fell to the floor. It was a transverse fracture with the beak-like appearance much like the pictures of these fractures that I have seen since in my research. I took Fosamax for 5 years. I was diagnosed with osteopenia in 2005. My then 86 year old mother had a hip fracture in 2002(she never took any of these drugs)and I was concerned about my bone health. There were no warnings on Fosamax until July 2009 regarding the possibility of femur fractures as a side effect. It is not being well-publicized and Merck has never acknowledged a connection, to my knowledge. Apparently, bone density can show improvement while at the same time the bones become more brittle. I am 67 years old and in constant fear that the other leg will break in the future. I am trying to follow all the good advice I see to help prevent this from happening again (including discontinuing Fosamax), improving diet and supplements, etc. and exercise, but it's crucial, especially for postmenopausal women, to know what they're getting into by taking these drugs. I did not know, nor did the mainstream medical community. It needs to be publicized more and perhaps the bisphosphonates should have "black box" warnings. These fractures are debilitating, expensive, and the rehabilitation process is long. Oh, and I might have to do it all again...! Thank you. Please spread the word!

Diane Merrill

September 28. 2010 09:49

Dear Diane,

We appreciate your taking the time to share your experience. The ASBMR recommendation to the FDA (which we hope the latter will take) is to put a more prominent warning on the drug labels. If you have not already done so, we suggest that you send the message above to the ASBMR via its scientific editor's blog (h ttp://community.asbmr.org/blogs/scientific_web_editor_blog/default.aspx), so that you can supply your story to aid them in their push to get this side effect added to the list of the FDA's warnings and precautions.

We wish you all the best in your recovery -- and we hope that you will look at our article, "How to speed fracture healing," for more information on how to best support the healing process. www.betterbones.com/bonefracture/speedhealing.aspx

Managing Editor

September 28. 2010 19:58

I have had two DEXA scans, two years apart, that show nearly the same levels of osteopenia.

In addition, blood tests show low levels of alkaline phosphatase (32 IU/L) over the course of a year.  Since alkaline phosphatase is involved in building bone, does this have any effect on my bone health?  If so, should I be taking a supplement?  

Other blood work is normal.

Susan

September 28. 2010 20:01

One more thing.  My vitamin D levels were 30 earlier this year, and are now 44.  I take vitamin D supplements.

Susan

September 29. 2010 09:48

Dear Susan,

We can't really answer the specific question you ask because we don't know your medical history. It's always good when vitamin D levels rise above the minimum level of 32 ng/dL, and it's also encouraging that your DEXA scans show that your bone mass is stable and you're not losing bone, but beyond that, we don't have sufficient information to advise you on what supplements you should (or shouldn't) take, and it wouldn't be in your best interest for us to try to do so in this forum anyway. So your best bet is to ask your doctor this question, as your physician will know your health status and will be better able to advise you. Alternatively, if you would like to work with Dr. Brown to develop a plan for building better bone health that's tailored to your needs, please contact the Center for Better Bones for a phone consultation (see our Consultations page).

Managing Editor

September 30. 2010 04:06

dear sir/madam
i have problem with my bone, it looks thin like sixteen year old child but i'm 21 years old now. So please help me what should i do.

Amit

September 30. 2010 09:49

Dear Amit,

You are fortunate in that being young, you are still in your peak bone-building years. If there is one single thing you can do to help your bones grow bigger and stronger, it's stay away from soda and sugar. But beyond that, we have several web pages that may be helpful. This one offers advice for teenagers (it is still useful for you even though you're a bit past that age): www.betterbones.com/betterbody/teenagersbones.aspx
and this one talks about the importance of balanced nutrition for bone health: www.betterbones.com/bonenutrition/default.aspx. Also, keep in mind that your muscles and your bones work as a team, so if you want to build and strengthen your bones, you need to work your muscles. Weight training is a particularly good way to do this, but you can do it by other means, including simply jumping rope every day. Please also see Susan's article on exercise for bone health: www.betterbones.com/healthylifestyle/exercise-bonesandosteoporosis.aspx. It was written for people who are older than you, but you may learn some useful tips about how you can better develop your muscles and bones through exercise.

Managing Editor

October 1. 2010 19:56

Dear Janet,
DHEA and progesterone are both hormones that influence bone.  DHEA is an adrenal hormone which can be a precursor of many other hormones.  If DHEA is low, supplementation with this hormone can help enhance bone strength.  Progesterone is an ovarian hormone important to bone just as is estrogen which is another ovarian hormone.  Low progesterone levels in young (premenopausal women) should be corrected. I will be publishing on this site a very interesting interview with progesterone specialist, Dr. Jerilynn Prior.  You might keep an eye out for this interview.  Studies using progesterone to enhance bone density in postmenopausal women have met with mixed results.  Best wishes, Susan

Susan Brown

October 13. 2010 08:51

My left femur fractured spontaneously (standing up , talking to friends), after 3 mos of thigh pain, and negative MRI and X-Rays. I took Fosamax under physicians care for 12 years. A gym goer and active athlete, I am in my mid 70's, of normal weight. An IM Rod was placed , I have had a non-union for a year, and now 15 mos later, about 75% healing. I now take Forteo, so I can walk again before geriatric problems begin.I belong to a support group on line started by Dr jennifer Schneider (Arizona) and herself a femur fx victim from Fosamax. A group of us have been to the FDA. There are many of us femur survivors out there, and it is only with diligence and perseverance that we have been recognized. The Bisphosphanates are a hugh problem that many professionals refuse to acknowledge. Thank You

Kay Datesman

October 13. 2010 17:53

I have the same question about alkaline phosphatase levels in blood work.  Mine has been consistently low (29-32) for the past 2 years (do not know what it was prior to that).  Since my early menopause at age 43, I have progressed from normal bone density to osteopenia.  I can't seem to get an answer from anyone as to whether the low alkaline phosphatase is anything to worry about and/or if it's in any way related to my diminishing bone density....all I can get is "we worry about it if it's high".  Any thoughts?  Thanks!

Susanne

October 13. 2010 19:47

I have a real problem with the doctors not knowing about these drugs. I'm a casual reader of medical journal and main stream media articles on topics related to older women's health, and I know. If the doctors truly didn't know, they are negligent. If they knew and prescribed anyway, they are criminal. I believe doctors DO know about these SAs but say they don't to clear themselves in the event of legal action.

riv

October 14. 2010 09:55

Riv, in defense of the physicians, it's not always that cut and dried. Some of them know about the SA's but may not know how to determine their patients' risk level, and they might believe that the risk/benefit ratio is in favor of the benefit when it actually is not. Some of them may not be up on the latest research because so much of their time is devoted to seeing patients and, unfortunately, filling out paperwork. Some of them may simply be more inclined to accept the paradigm that treatment = pharmacotherapy than to try to work with patient on natural alternatives because that's how they were trained to think in med school. And there are also some patients for whom pharmacotherapy is actually necessary because of the accelerated rate of bone loss -- but because osteoporosis has been marketed to the medical community as a disease itself, rather than as a symptom of underlying disease, they don't know to look any farther to heal the patient of the causes of bone loss (see www.betterbones.com/osteoporosis/secondaryosteoporosis.aspx). That is slowly changing, and we're trying to revolutionize bone health by promoting understanding of these factors in both patients and physicians.

In sum, this is a systemic problem, not an individual failing -- our healthcare system is no more supportive of physicians attempting to give the best care to their patients than it is to patients attempting to support their health.

Managing Editor

October 25. 2010 07:00

In 2009 after 7 years of taking Fosamax, I stopped taking the drug because of all the warnings that became available.  Throughout the day I experience a sporadic ache in my right thigh.  Could this be the pain that others experience prior to a fracture?

Janice Horbowicz

October 26. 2010 11:01

Dear Janice, given your history, we would recommend you take your concerns to your physician. This is not something to take lightly and you should have it checked out. It may be something as simple as a muscle spasm, but it's better to bring it to your doctor's attention and find it's nothing to worry about, than to ignore it (and worry) only to find that you should've paid attention. But our hope for you is that you'll receive reassurance from you physician when you discuss your concerns. After all, worry is bad for bones too!

Managing Editor

November 18. 2010 18:41

I am taking Evista and calcium to treat my osteopenia.  My bone density has returned to the normal range.  Are there any side effects to Evista?

ruth harrison

November 19. 2010 15:44

Dear Ruth, all drugs have side effects, but you're asking about the bone-related side effects that are so concerning about Fosamax and Actonel, correct? Evista is not like these bisphosphonate drugs or even the more aggressive new bone drugs like Forteo and Prolia because it doesn't directly target the processes of bone turnover. Evista is a "selective estrogen receptor modulator" and it was originally developed in the hope of reducing women's risk of breast cancer (it was intended to be a replacement for tamoxifen, but it didn't prove to be any more effective in treating or preventing breast cancer). The drug did produce improved bone density in the women who participated in early clinical trials, so the drug company got it approved for this use because it can be used in postmenopausal women to address two of the most frightening conditions women face, breast cancer and osteoporosis -- not a bad selling point, from the drug company's perspective.

Of course, there are drawbacks, and if you want information about other side effects associated with Evista, you can look at the informational sheet provided by its manufacturer here: pi.lilly.com/us/evista-ppi.pdf -- from a quick glance, it seems as though the major concern with this drug is blood clots leading to DVTs (deep venous thromboses) and strokes.

Managing Editor

January 24. 2011 09:32

My mother had taken fosimax for 10 years. Unfortunately her femur broke for no apparent reason at the time, she did not fall, her thigh bone just broke and she fell to the floor. Her quality of life for her end of life years have been severely affected, as before the break she could move around normally and now she can't move without a walker or wheelchair. I KNOW it was the drug she was taking, and I convinced her a year ago to quit. She really thought she was taking care of herself all those years by taking the "wonder drug" fosimax. I am so upset with the drug companies, and anyone else that is financially benefiting from the sale and use of these poisons. We recently got my mother on the class action law suit building against the crooks that have harmed so many woman. Everytime I see Sally Fields lying on tv makes me sick.

kathy shopa

February 7. 2011 17:12

I was diagnosed with osteoporosis 2 years ago, age 49. My menopause was age 40(family history) and I suffer with osteo-arthritis (controlled). It was suggested that I consider taking one of the drugs available but was not keen to do this having already done a lot of reading about them.
My specialist, knowing I was anti-drugs, assessed me as in low chance of fracture category.  
Over the past 2 years I have upped my gym days, and watch my diet.
My diet has always been pretty good though, so I have added anything to it that is said to be good for bone health.
I had not looked into the alkaline diet til now though,so will be trying to do that to.  My D level is 84 and good.  I take progesterone 150mg and zinc 600mcg daily.  I have heard Calcium is not good to take in tablet.  Is this correct?
I'm due to have another BMD test next month, and are very concerned as to the results.

I would be happy to hear from you on anything more I should do or what I am doing wrong.

Leanne Franklin

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