Case Report Of Bilateral Femur Fractures In Patient Using Fosamax

Medical Journal Article Points To Imbalance Between Bone Resorption And Bone Formation At Affected Bone

(Posted by Tom Lamb at DrugInjuryWatch.com)

In the October 2009 edition of the Journal of Bone and Mineral Research we found an article which advances the epidemiology of bisphosphonate-related femur fractures.

This medical journal article, "Bilateral Fractures of the Femur Diaphysis in a Patient With Rheumatoid Arthritis on Long-Term Treatment With Alendronate: Clues to the Mechanism of Increased Bone Fragility", deals with a patient with rheumatoid arthritis and multiple risk factors for fractures who was treated with Fosamax (alendronate) for eight years and developed spontaneous bilateral subtrochanteric/diaphyseal fractures.

From the Abstract for this October 2009 article:

Bone biopsies obtained form the iliac crest and the femur showed decreased bone formation with histomorphometric evidence of markedly increased bone resorption at the femur. These results show for the first time that an imbalance between bone resorption and bone formation at the affected bone is associated with the occurrence of these atypical femur fractures.  The cause of this imbalance is currently unknown, and further studies of the epidemiology and pathogenesis of diaphyseal femur fractures are warranted.

As we have reported previously, atypical femur fractures have been reported in patients treated with Fosamax.

As the authors of the October 2009 case report article point out:

[A]lthough no causal relationship has been established between Fosamax and these femur fractures], excessive suppression of bone turnover and length of treatment with alendronate have been implicated in their pathogenesis.

We will continue to monitor this emerging drug safety issue involving Fosamax and femur fractures.

______________________________________________________________________________

DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects





7 responses to “Case Report Of Bilateral Femur Fractures In Patient Using Fosamax”

  1. Hap Remodeler PhD MD Avatar

    Dr Odvina first published observations of this effect in the JCEM in December 2004. She termed it severely suppressed bone turnover or SSBT. There are currently more than 100 case reports in the medical literature of these subtrochanteric diaphyseal unilateral or simultaneous bilateral femoral fractures (and notably, other predominantly cortical bone loci) associated with the use of Fosamax or other bisphosphonates (BPs). There are several facts that support the hypothesis that this is a class-effect but the recent association has been predominantly with Fosamax. In my opinion this is because (a) there is a greater number of long-term users of this drug as it was the first BP approved (1995) for use in benign osteoporosis, and (b) much more importantly, it has the highest affinity for bone mineral of all of the oral BPs, giving it a persistence in bone second only to zoledronate. It is well known that Fosamax is also associated with osteonecrosis of the jaw (ONJ). A few modern cases of ONJ and femoral fractures have been reported in the same individual. What is far less well-known is that many cases of the simultaneous syndromes were reported in the 19th century literature as “phossy jaw” and “fragilitas ossium”, in the absence of any bisphosphonate, certainly, but associated with exposure to industrial phosphorus processing. It was not for nothing that Fosamax was so-named, as it contains two phosphonic acid residues, as do all the drugs in this class. This moiety is almost unique in the modern pharmacopoeia and the use of non-metabolized drugs such as the BPs in humans is, in my opinion, unprecedented, and based on the historical perspective, hazardous indeed.

  2. Omar C Funes Avatar
    Omar C Funes

    Is there any study or correlation made between patients’ age or gender and this atypical fractures?

  3. Tom Lamb Avatar

    Hap:
    Thanks for taking the time to share your learned knowledge about bisphosphonates, Fosamax in particular, and the associated side effects of femur fracture and osteonecrosis of the jaw (ONJ).
    I have read your Comment with great interest, and I am sure other readers, also, have gained insight from what you have provided us.
    I hope you keep reading Drug Injury Watch.
    Tom Lamb

  4. Tom Lamb Avatar

    Omar:
    Thanks for your inquiry.
    Unfortunately, I do not have any references to direct you to for a definitive answer to your question.
    I can tell you, however, that most of the cases we have seen involve women you are aged 60 years or older.
    I hope you continue to read Drug Injury Watch.
    Tom Lamb

  5. Jeffrey Dach MD Avatar

    Fosamax, A Bad Drug in Litigation
    The Fosamax (Alendronate) study done for FDA approval failed to show any benefit for the osteopenia group where fracture rates actually went up. This data was data published by Cummings in JAMA in 1998 (the FIT study, which stands for Fracture Intervention Trial).
    Problem Two: Bisphosphonates drugs like Fosamax have severe adverse side effects of jaw necrosis (OJN), spontaneous mid-femur fracture, heart rhythm disturbances, and severe bone and joint pain.
    Tom, these are bad drugs that should be banned. The ball is in your court.
    To read more…
    http://jeffreydach.com/2009/08/31/fosamax-in-bad-drug-litigation-by-jeffrey-dach-md.aspx
    jeffrey dach md

  6. Tom Lamb Avatar

    Dr. Dach:
    I appreciate you letting us know about your recent article about the various drug-safety issues concerning Fosamax.
    For those who want to get the benefit of Dr. Dach’s research on Fosamax side effects, I encourage you to use the link he provides, above, to read his full article.
    Tom Lamb

  7. Tom Lamb Avatar

    The medical articles about femur fractures in long-term users of Fosamax have been getting attention recently, but many prescribing and treating doctors have still not learned about this possible Fosamax side effect, yet.
    A March 8, 2010 ABC News report about Fosamax-related low stress fractures of this thigh bone will likely make it a more well-known drug injury, now. Here is a link to that ABC News report:
    http://abcnews.go.com/WN/WorldNews/osteoporosis-drugs-fosamax-increase-risk-broken-bones-women/story?id=10044066
    To learn more, see the Fosamax Information Page at our Drug Injury Law web site:
    http://www.druginjurylaw.com/Fosamax-information.php
    Let me know if we can be of further assistance to you or someone you know.
    Tom Lamb

Leave a Reply to Hap Remodeler PhD MD Cancel reply

Your email address will not be published. Required fields are marked *