Fosamax Induced Bilateral Femur Fractures

by Jeffrey Dach MD

I received this email comment on my blog from a lady who suffered bilateral mid-femur fractures after ten years of Fosamax (Alendronate):
  __________________________

Dear Dr. Dach,

I am a femur-fracture survivor...bilateral. The right leg broke in March, (see image) the left one in July, 2009. I also suffered a compression fracture at L1 in May.

I was given Fosamax 10 years ago as a preventive measure. Now I am worse than I would have been 20 years down the road. I cannot begin to tell you that there are women breaking a leg everyday! And they do not know why. It was through the fact, that the orthopedic doctor who took my emergency case on the first leg, had just received some information about the bilateral fractures. If you held my x-ray up against several other womens, you could not tell us apart!

I hope you continue to write and correspond about this important subject. My life has been taken away from me in a way that I never dreamed would happen.

Thank You, Vicki S.
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A Reply to Vicki from Dr. Dach:
 
Dear Vicki,

Thanks coming forward to share your story of Fosamax induced Femur Fractures.

As you know, this type of fracture is very unusual, and only occurs in abnormal bone.
This is called "pathological fracture" and is caused by change in bone quality induced by Fosamax.  These pathological mid femur fractures heal very poorly even with the best of treatment.

Fosamax, Actonel, Boniva and all the bisphosphonates work by killing the osteoclast bone cells.  This creates pathologic abnormalities in bone architecture that leads to increased bone density on the DEXA scan.  Paradoxically, this dense bone is weaker, brittle and prone to pathological fracture at the mid-shaft level of the femur.  A fracture at this mid -femur location is highly characteristic of a Fosamax induced fracture.

We have been hoodwinked by the Sally Fields Television ads and deceitful marketing campaigns. These are bad drugs. I predict that as mid-femur pathologic fractures become more common, people will start to wake up, and eventually these drugs will be banned.

Vicki, I am very sorry that this happened, and hopefully your efforts will educate others about this pitfall.

Sincerely, Jeffrey Dach MD
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Reports of Spontaneous Mid Femur Fracture on Fosamax

Clarita Odvina MD reported nine cases of spontaneous femur fracture on Fosamax (Alendronate).   

Dr. Goh, a doctor in Singapore, identified nine more cases in his 2007 report of subtrochanteric femur fractures with minimal trauma in women on long term Fosamax. 

Joseph M Lane MD reported 15 cases of spontaneous femur fracture in women on Fosamax (Alendronate).  His report appeared in the New England Journal  March 20, 2008.

Lane found that "ten of the 15 patients were found to share a unique radiographic pattern, defined as a simple transverse or oblique (30°) fracture with beaking of the cortex and diffuse cortical thickening of the proximal femoral shaft."


Above First Femur Fracture Xray courtesy of Joseph Lane MD, unique radiographic pattern of Fosamax induced fracture of femur. Above Second Fracture Xray, Spontaneous Femur Fracture Induced by Long Term Fosamax Courtesy of Jennifer Schneider MD.

More Case Reports from Jennifer Schneider MD

These additional case reports were published in 2009 Geriatrics by Jennifer Schneider MD (link to publication):

A 66-year old, previously healthy woman developed a
spontaneous stress fracture of her right foot, which
eventually healed. Nine months later she took a step
in her bedroom and collapsed to the floor. An x-ray revealed
a nontraumatic fracture of her right femur. She
underwent surgery with placement of an intramedullary
rod. Her physician told her she had most likely had a stress
fracture, which became a completed fracture. A bone scan
done shortly after her surgery revealed a stress fracture of
her left femur. Some months later she underwent prophylactic
rodding of the left femur. The patient had been on
alendronate for 7 years.

A 65-year woman visiting Europe stepped off the bottom
step of a van and collapsed. An x-ray revealed a nontraumatic
fracture of her left femur. She had been experiencing
a dull ache in her left femur for some months. The patient
underwent placement of an intramedullary rod. One year
later she developed a dull ache in her right femur. A bone
scan showed a stress fracture in the right femur. A bone
specialist recommended prophylactic rodding of the right
femur, which was done. The patient had been on alendronate
for 9 years.

A 59-year-old-woman took a step, her right leg gave out,
and she fell to the ground as she heard her leg break. Her
femur was fractured. The orthopedic surgeon on call told
her, “We don’t usually see this type of fracture without
trauma.” For the preceding year she’d experienced pain in
her right thigh, which was severe enough to cause limping.
An x-ray had been negative, and her primary care physician
thought she had fibromyalgia. She had been on alendronate
for more than 5 years.

Drug Companies Fight Back Attempting to Exonerate Fosamax

The drug companies are aware of this problem, and are fighting back by paying doctors to deny the link between fosamax and pathological fracture of the femur.  An example is this study of the Danish National Bone Registry: 

"Something is Rotten in Denmark"

Subtrochanteric and Diaphyseal Femur Fractures in Patients Treated With Alendronate: A Register-Based National Cohort Study by Bo Abrahamsen,  Pia Eiken, Richard Eastell in the Journal of Bone and Mineral Research June 2009:24:1095-1102   (link)

"Recent reports have found long-term Alendronate use to be common in patients with subtrochanteric or proximal diaphyseal femur fracture, raising concerns that these fractures could be a consequence of excessive suppression of bone turnover."

Fosamax Doubles the Risk of Subtrochanteric Fracture

Even though the Danish Registry data actually showed the Fosamax (alendronate) group had an increased incidence of subtrochanteric fractures (2.9 vs. 1.6 per 1000 patient years), nonetheless, Dr. Bo Abrahamsen concluded the cause was osteoporosis and NOT the Drug !!

Here is their blatantly false conclusion: "Subtrochanteric/diaphyseal femur fractures ... are best classified as osteoporotic fractures."  This conclusion is a blatant lie and a falsehood.  These mid-femur fractures are NOT osteoporotic fractures, and I will explain why.

Authors On Drug Company Pay Roll

Here is a list of author's competing interests:

Dr. Abrahamsen receives consultancy fees from Nycomed and Novartis, research grants from Roche, and speaker's fees from Servier, Eli Lilly, and MSD. Dr. Eiken receives speaker fees from Nycomed, Roche, and Servier. Dr. Eastell receives research funding or consultation honoraria from Amgen, AstraZeneca, Aventis, Eli Lilly, GlaxoSmithKline, Hologic, Interleukin Genetics, Kyphon, Lilly, Maxygen, Nastech Pharmaceuticals, Nestle Research Center, New Zealand Milk Limited, Novartis, Novo-Nordisk, Ono Pharma, Organon, Osteologix, Paraxel, Pfizer, Procter & Gamble, Roche Diagnostics, Sanofi-aventis, Servier, Shire, Transpharma Medical Limited, Unilever, and Unipath.

Sound familiar?

Fosamax Induced Fractures have a UNIQUE Radiographic Appearance

Joseph M Lane MD reported a unique radiographic pattern of these Fosamax induced fractures.  This means these spontaneous mid-femur fractures are pathological fractures induced by the drug, and virtually NEVER happen unless the patient is on FOSAMAX.

The Anatomy Dictates that the Femoral Neck Will Fracture First  

Osteoporotic fractures present most commonly as compression fractures of the vertebral bodies, or as femoral neck fractures.  Even in cases of severe osteoporosis, the femur never spontaneously fractures at the mid femur level simply because the anatomy dictates that the femoral neck will fracture first.  I have known this from personal experience as a radiologist for thirty years reading X-Rays of fracture cases.  A spontaneous mid-femur fracture is extremely rare and indicates a pathologic fracture caused by a drug or disease process.

Fosamax Same Unique Pattern As Rare Genetic Bone Disease of Toulouse Lautrec

My previous article highlighted the similarity between Fosamax induced femur fractures and a rare genetic bone disease, Pycnodysostosis, also called Toulouse Lautrec's Disease.  This genetic disease causes malfunctioning osteoclasts, the same mode of action of the drug, Fosamax. 

Lautrec, the famous French Impresionist artist, suffered bilateral femur fractures which never healed properly resulting in short stature, as shown in the above photographs.  Lautrec's femur fractures had the same unique radiographic appearance described by Dr Joseph Lane for Fosamax induced femur fracture.

Summary: Fosamax induced mid-femur fractures have a unique radiographic appearance, and share this unique appearance with a rare genetic bone disease (Toulouse Lautrec's Disease).  Therefore, these mid-femur fractures are not typical osteoporotic fractures, they are a distinct form of pathologic fracture induced by the drugs, Fosamax, Actonel and Boniva.  It is time to ban these drugs.

Articles with Related Content:

Bisphosphonates for Osteoporosis, A Closer Look at the Data by Jeffrey Dach MD


Osteoporosis Drugs Cause Osteo-Necrosis of the Jaw by Jeffrey Dach MD


Fosamax, Actonel, Osteoporosis and Toulouse Lautrec by Jeffrey Dach MD


Links and References:

http://www.jenniferschneider.com/articles/Bisphosphonates.pdf
Bisphosphonates and low-impact femoral fractures:Current evidence on alendronate-fracture risk by Jennifer P. Schneider, MD, PhD. Geriatrics.2009;64(1):18-23.

http://jcem.endojournals.org/cgi/content/full/90/3/1294
The Journal of Clinical Endocrinology & Metabolism Vol. 90, No. 3 1294-1301
Severely Suppressed Bone Turnover: A Potential Complication of Alendronate Therapy
Clarita V. Odvina, Joseph E. Zerwekh, D. Sudhaker Rao, Naim Maalouf, Frank A. Gottschalk and Charles Y. C. Pak

 

http://www.jbjs.org.uk/cgi/content/abstract/89-B/3/349
Journal of Bone and Joint Surgery - British Volume, Vol 89-B, Issue 3, 349-353.
Subtrochanteric insufficiency fractures in patients on alendronate therapy A CAUTION

S.-K. Goh, MA, MRCS, Registrar1; K. Y. Yang, FRCS(Orth), Consultant Orthopaedic Surgeon1; J. S. B. Koh, FRCS(Orth), Consultant Orthopaedic Surgeon1; M. K. Wong, FRCS(Orth), Senior Consultant Orthopaedic Surgeon1; S. Y. Chua, MRCS, Registrar2; D. T. C. Chua, FRCS(Orth), Senior Consultant Orthopaedic Surgeon2; and T. S. Howe, FRCS(Orth), Senior Consultant Orthopaedic Surgeon and Director of Trauma1

http://content.nejm.org/cgi/content/full/358/12/1304
NEJM Volume 358:1304-1306  March 20, 2008  Number 12
Atypical Fractures of the Femoral Diaphysis in Postmenopausal Women Taking Alendronate Brett A. Lenart, B.S. Dean G. Lorich, M.D. Joseph M. Lane, M.D. Weill Cornell Medical College New York, NY 10021  (image courtesy of dr lame)

http://www.medpagetoday.com/MeetingCoverage/ASBMR/10904
Alendronate Exonerated in 'Atypical' Femoral Fractures By Michael Smith, North American Correspondent, MedPage Today. September 15, 2008 Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco .

MONTREAL, Sept 15 -- Atypical fractures of the femur do not appear to be triggered by the anti-osteoporosis drug alendronate (Fosamax), a Danish researcher said here.
The risk was dismissed despite a large Danish registry cohort analysis showing that alendronate use was indeed significantly associated with an increased risk of atypical fractures, as has been proposed on the basis of three case reports.

The alendronate group had an incidence of subtrochanteric fractures of 2.9/1,000 patient years, compared with only 1.6 among the controls. While that finding would seem to confirm fears about the drug, the rate of hip fracture was also significantly higher (P<0.001) in the alendronate group -- 17 per 1,000 patient-years, compared with 11.

Abrahamsen B, et al "Subtrochanteric And Diaphyseal Femur Fractures in Patients Treated with Alendronate: A Register-Based National Cohort Study" JBMR 2008; 23: Abstract 1026.

Jeffrey Dach MD
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