Chapter 35. Fosamax™ for Pre-Osteoporosis, A Bad Idea

Chapter 35. Fosamax™ for Pre-Osteoporosis, A Bad Idea

A number of patients have recently told me their primary care doctors started them on Fosamax™ for "pre-osteoporosis" a condition less severe than full blown osteoporosis, also called "osteopenia".  This is a very bad idea.  Osteopenia is defined by the DEXA T-Score (see below).

Problem One: The Fosamax™ (Alendronate) medical study for FDA approval failed to show any benefit for the Osteopenia Group.  Fracture rates actually went up for the Osteopenia Group.  This data was published by Cummings in JAMA in 1998 (this is called the F.I.T. study, which stands for Fracture Intervention Trial).(8)

Problem Two: Bisphosphonates drugs like Fosamax have severe adverse side effects of jaw necrosis (OJN), spontaneous femur fracture, atrial fibrillation (a heart rhythm disturbance), and severe bone and joint pain.  Another common adverse effect is esophageal erosion, heartburn and esophageal reflux.(10)

Fosamax, A Bad Drug in Litigation - How to Recognize a Bad Drug?

One of the early warning signs of a bad drug is ongoing drug litigation for adverse side effects.  This calls the drug into question as a BAD DRUG.  Fosamax drug litigation began August 2009 against Merck by plaintiff, Shirley Boles, age 71, who suffered ONJ (osteonecrosis of the jaw) allegedly from Fosamax.  OJN, osteonecrosis of the jaw, is a well known adverse side effect of Fosamax, which has been heavily documented in the dental and oral surgery medical literature.  Merck faces an onslaught of more than 900 cases awaiting litigation. (2-5)

Spontaneous Femur Fracture Induced by Fosamax

Another warning sign of a BAD DRUG is spontaneous femur fracture (with no trauma) that occur in women on Fosamax.  A number of these embarrassing reports have appeared in the New England Journal of Medicine and the Orthopedic Surgery medical literature.(9)(13)(14)   Two more embarrassing studies came out at the 2010 American Academy of Orthopaedic Surgeons (AAOS) Meeting showing Fosamax disturbs bone formation, and implicates Fosamax in spontaneous mid-femur fractures (without trauma). These reports came from the Hospital for Special Surgery (HSS) and Columbia University Medical Center. (11)

FDA Warning Letters – Another Red Flag

Another sign of a BAD DRUG is the FDA Warning letter.(1)   Physicians received such an FDA  warning letter telling them about severe, incapacitating bone and joint pain caused by Fosamax.  What causes this pain? No answer there.  I would suggest underlying stress fracture as the cause for the severe bone pain. Another FDA safety announcement was made March 10, 2010 (12),and another FDA warning letter was sent to physicians on October 12, 2010, warning about “Possible increased risk of thigh bone fracture with bisphosphonates”.(18-19)(25)  The drug companies have not yet explained why this  “wonder drug” intended to prevent fractures actually causes spontaneous femur fractures.  

Consumer Complaints Against Fosamax

Another warning sign of a bad drug is the number of consumer complaints on message boards which can be seen by anyone with an internet connection.  You are encouraged to perform an internet search of the key words where you will find hundreds of consumer complaints.(6)

Why is Fosamax a BAD Drug ?

There is no question that bisphosphonates drugs increase bone density as measured on the DEXA scan. I would be the first to admit this.  I have seen it routinely.  So, one might ask,  why are these “Bad Drugs”?  The answer is the following: The increased bone density is cosmetic and does not equate with stronger bone.  This is deceptive. Simply put, the bisphosphonate drugs create pathologic bone that is weak and brittle, prone to spontaneous fracture and osteo-necrosis.  The drug actually does the reverse of what it is intended to do.

FDA Says Osteoporosis Drugs Cause Femur Fractures – The Perfect Storm

For years, I have been warning patients, friends and family members about the adverse effects of osteoporosis drugs.  Finally, after years of dragging their feet, the FDA issued a news release on Oct 13, 2010 warning of "possible" risk of femur fractures caused by the osteoporosis drugs such as Fosamax™, Boniva™, and Actonel™. (18-19)  They also added a new warning label recommended by a the Bone Task Force assigned to examine this issue.(20-21)  The Task Force found that almost all women suffering from atypical fractures of the mid femur were on bisphosphonate osteoporosis drugs like Fosamax™, Actonel™, and Boniva™.  (21)  (Note: The task force consists of experts of the American Society of Bone and Mineral Research).   This same ASBMR task force previously issued a 2007 report on these same osteoporosis drugs causing osteonecrosis of the jaw (OJN).(26)  This is a condition in which the jaw bone literally “falls apart”, usually after a dental procedure.    When a drug adverse effect is identical to the underlying disease the drug is supposed to treat, we have “the perfect storm” . Osteoporosis drugs are marketed and sold as fracture preventive, and are not supposed to cause fractures.  Yet, we now have evidence that this class of drugs not only weakens bones, they also cause spontaneous femur fractures.  This is a very bad thing, and indicates a very profound problem with the drug.

Dr Susan Ott Reports on Stress Fractures Induced by Bisphosphonates

At a 2010 medical meeting, of the Bone Society (ASBMR) in Toronto, Susan Ott MD presented data on atypical femur fractures induced by osteoporosis drugs like Fosamax. (27)  She reviewed X-Rays and data from a large California HMO called Kaiser Permanente.  Over a three year period, Kaiser HMO doctors reported 135 atypical femur fractures out of a total of 16,000 broken femurs.  Almost all of the 135 patients were on bisphosphonate drugs (96.4%), similar to Fosamax.   Dr. Ott reported these atypical fractures have a characteristic X-ray appearance, and may occur bilaterally. The fracture is typically through the mid-shaft of the femur , and the outer bony margin typically thickened, indicating  a stress fracture.  These fractures occur spontaneously, on their own, with no fall or traumatic event.  Patients typically report pain in the area for weeks or months before the actual fracture.  Dr. Ott reported an incidence of 0.25 % for atypical mid femur fractures in patients on bisphosphonate drugs for 12 years.  Dr Ott is not the first to describe the link between Fosamax and femur fractures.  A 2009 report from Sweden by Dr. Aspberger disclosed that the incidence of mid femur stress fracture is 50 times higher for patients on bisphosphonates drugs compared to untreated women (0.1% vs. 0.002 %). (39)

Stress Fractures from Osteoporosis Drugs

Dr Isaacs from Australia reported Aug 2010 that bisphosphonate drugs cause insufficiency fractures of the femur  (also called stress fractures). (28)  Dr Isaacs reviewed X-rays of one hundred consecutive patients suffering from spontaneous femur fracture.  Some cases occurred before and some after the availability of bisphosphonate drugs.  He found X-Ray evidence of pre-existing stress fractures in all 41 patients taking bisphosphonate drugs.  However, before the bisphosphonate era, in the group NOT TAKING bisphosphonates, there were no pre-existing stress fractures seen in any of the twenty one patients in this group.  These patients had their spontaneous femur fracture before the bisphosphonate era.  Dr. Isaacs suggested that bisphosphonate drugs cause damage and weakens bone, making it susceptible to painful stress fracture, the initiating lesion later progressing to complete femur fracture.   This explains the prodromal pain before the spontaneous femur fracture. 

What is the Next Step - A Black Box Warning or Ban the Drug?

The recent medical literature has been inundated with case reports and population studies linking bisphosphonate drugs like Fosamax and Actonel to atypical mid-femur fractures, as well as stress fractures. The message is fairly obvious that there is something dreadfully wrong here.  When we have a drug that causes the same disease it is intended to prevent, we have the "perfect storm".   Drug manufacturers use ghost-writers to manipulate data from clinical trials to make the drug look good, and clinicians can deny the obvious when patients come in with fractures while on the drug, blaming the fracture on underlying osteoporosis, and not an adverse effect of the osteoporosis drug.  My prediction is that most educated patients and doctors will abandon this bisphosphonate family of osteoporosis drugs, and the FDA will eventually issue a Black Box Warning or perhaps a ban on the drug.  When this happens, we can say goodbye to another "bad drug". 

Reverse Osteoporosis Naturally-Our Program

Rather than use a “Bad Drug”,  like the bisphosphonates such as Fosamax, a far better solution for reversing osteoporosis is a combined program of lifestyle modification, diet, nutrition, exercise and bio-identical hormone supplementation.

For more on Bad Drugs, see my previous e-book, Natural Medicine 101 which can be found at www.naturalmedicine101.com .

For references and links, see my web site: www.bioidenticalhormones101.com

Chapter 35. Fosamax™ for Pre-Osteoporosis, a Bad Idea

(1) http://www.newsinferno.com/archives/2326 Actonel, Fosamax, other Osteoporosis Drugs Draw FDA Pain Warning. Date Published: Monday, January 7th, 2008

(2) http://www.theage.com.au/world/down-to-the-bone-20090807-ecwy.html Down to the bone RAY MOYNIHAN August 8, 2009

(3) http://www.fiercepharma.com/story/bellwether-fosomax-trial-starts-today/2009-08-10 Bellwether Fosamax trial starts today August 10, 2009 by Tracy Staton.  Fierce Pharma.

(4) http://www.bloomberg.com/apps/news?pid=20601103&sid=aN.O.OLorMnc Merck Faces First Trial of Claim That Fosamax Attacks Jawbone By Thom Weidlich and Margaret Cronin Fisk Bloomberg News

(5) http://www.youhavealawyer.com/blog/2008/08/21/fosamax-lawsuits-pile-up/ Fosamax Lawsuits Continue to Pile Up Against Merck  August 21st, 2008 by Austin Kirk

(6) http://www.consumeraffairs.com/rx/fosamax.html consumer complaints about Fosamax

(7) http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124165.htm Information for Healthcare Professionals: Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa) FDA ALERT [1/7/2008]:

(8) http://jama.ama-assn.org/content/280/24/2077.full  Effect of Alendronate on Risk of Fracture in Women With Low Bone Density but Without Vertebral Fractures Results From the Fracture Intervention Trial Steven R. Cummings, MD et al. for the Fracture Intervention Trial Research Group JAMA. 1998;280(24):2077-2082

(9) http://www.nejm.org/doi/full/10.1056/NEJMc0707493  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. N Engl J Med 2008; 358:1304-1306March 20, 2008

(10) http://blogs.consumerreports.org/health/2010/03/safety-news-on-fosamax-and-boniva-should-you-still-take-fosamax-or-boniva-to-strengthen-bones-.html March 12, 2010 Should you still take Fosamax or Boniva to strengthen bones? By Alan Cassels. Consumer Reports Health Blog.

 (11) http://www6.aaos.org/news/pemr/releases/release.cfm?releasenum=877  Quantity vs. Quality: Long-Term se of Bone-Building Osteoporosis Drugs May Affect Quality and Structural Integrity of Bone. Studies find possible links between prolonged bisphosphonate treatments and atypical fractures in post-menopausal women. NEW ORLEANS, LA . Lauren Pearson 03/10/2010 .2010 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS).

(12) http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm    FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures. 03-10-2010

(13)  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

(14) 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 et al.

(15)  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

(16) 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 et al.

(17) 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 

(18) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm229171.htm
FDA NEWS RELEASE Oct. 13, 2010. FDA: Possible increased risk of thigh bone fracture with bisphosphonates. Labeling change adds warning about possible risks of long-term use of osteoporosis drugs 

(19) http://online.wsj.com/article/BT-CO-20101013-710300.html
Wall Street Journal. OCTOBER 13, 2010, FDA Warns On Risk Of Thigh Bone Fractures With Bisphosphonates Drugs. FDA: Possible increased risk of thigh bone fracture with bisphosphonates

(20) http://www.fda.gov/Drugs/DrugSafety/ucm225681.htm FDA Statement on ASBMR report: Possible Increased Risk of Certain Types of Thigh Bone Fractures with Long-Term Bisphosphonates Use. 9/14/2010. FDA appreciates the report from the American Society of Bone and Mineral Research's (ASBMR's) expert Task Force

(21) http://www.ncbi.nlm.nih.gov/pubmed/20842676
J Bone Miner Res. 2010 Nov;25(11):2267-94. Atypical subtrochanteric and diaphyseal femoral fractures: report of a task force of the American Society for Bone and Mineral Research.  Shane E et al.

(22) http://www.asbmr.org/about/pressreleases/detail.aspx?cid=a68f2b70-a117-4094-9f6f-b5993c6a6149
JBMR Publishes ASBMR Task Force Report on Atypical Femoral Fractures.September 14, 2010
Panel Says May be Related to Unusual Thigh Bone Fractures When Used Long Term Expert Panel Calls for Additional Product Labeling, International Patient Registry

(23) http://www.pharmacist.com/AM/Template.cfm?Section=Pharmacy_News&template=/CM/ContentDisplay.cfm&ContentID=24482  FDA warns of femoral fracture risk with bisphosphonates

(24) http://www.aafp.org/online/en/home/publications/news/news-now/clinical-care-research/20101018bisphosphonatelabel.html  AAFP . FDA Warns Docs, Patients of Femoral Fracture Risk Linked to Some Bisphosphonates Long-term Use Suggests Need for Periodic Bone Density Reassessment 10/18/2010  

(25) http://www.empr.com/bisphosphonates-labeling-updated-to-include-atypical-fractures-warning/article/180939/ Bisphosphonates labeling updated to include atypical fractures warning
October 13, 2010  

(26) http://www.ncbi.nlm.nih.gov/pubmed/17663640
J Bone Miner Res. 2007 Oct;22(10):1479-91. Bisphosphonate-associated osteonecrosis of the jaw: report of a task force of the American Society for Bone and Mineral Research. Khosla S et al.

(27) http://www.medpagetoday.com/MeetingCoverage/ASBMR/22859
 Analysis Adds to Evidence of Unusual Fractures. By Michael Smith , North American Correspondent, MedPage Today Published: October 20, 2010  Reviewed by Zalman S. Agus, MD

(28) http://www.ncbi.nlm.nih.gov/pubmed/20809164
Clin Orthop Relat Res. 2010 Dec;468(12):3384-92. Femoral Insufficiency Fractures Associated with Prolonged Bisphosphonate Therapy.  Isaacs JD, Shidiak L, Harris IA, Szomor ZL. The St George and Sutherland Hospital Orthopaedic Departments, Sydney, NSW, Australia,

(29) http://www.ncbi.nlm.nih.gov/pubmed/20425089
Curr Osteoporos Rep. 2010 Mar;8(1):34-9. Atypical subtrochanteric and femoral shaft fractures and possible association with bisphosphonates. Nieves JW et al.

(30) http://www.ncbi.nlm.nih.gov/pubmed/20524451
J Med Assoc Thai. 2010 May;93(5):620-4. Bilateral atypical femoral fractures after long-term alendronate therapy: a case report. Bamrungsong T, Pongchaiyakul C.

(31) http://jama.ama-assn.org/cgi/reprint/304/13/1480.pdf
JAMA. 2010;304(13):1480-1484 Atypical Fractures as a Potential Complication of Long-term Bisphosphonate Therapy. By Deborah E. Sellmeyer

(32) http://www.ncbi.nlm.nih.gov/pubmed/20489100
AJR Am J Roentgenol. 2010 Jun;194(6):1581-6. Subtrochanteric femoral fractures in patients receiving long-term alendronate therapy: imaging features.  Chan SS, Rosenberg ZS, Chan K, Capeci C.

(33) http://www.ncbi.nlm.nih.gov/pubmed/20954650
Orthopedics. 2010 Oct 11;33(10). doi: 10.3928/01477447-20100826-31. Bilateral simultaneous femoral diaphyseal fractures in a patient with long-term ibandronate use. Patel VC, Lazzarini AM.

(34) http://www.ncbi.nlm.nih.gov/pubmed/20436006
J Bone Joint Surg Br. 2010 May;92(5):679-86. A rational approach to management of alendronate-related subtrochanteric fractures.Das De S, Setiobudi T et al

(35) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2917569 Acta Orthop. 2010 August; 81(4): 460–462.  Histology of an undisplaced femoral fatigue fracture in association with bisphosphonate treatment Frozen bone with remodelling at the crack Per Aspenberg, Jörg Schilcher, and Anna Fahlgren

(36) http://www.ncbi.nlm.nih.gov/pubmed/20374333  Int J Rheum Dis. 2009 Jul;12(2):149-54. Bilateral atypical femoral diaphyseal fractures in a patient treated with alendronate sodium.  Lee JK.J. K. Lee Orthopedic and Traumatology, Petaling Jaya, Selangor, Malaysia.

(37) http://www.ncbi.nlm.nih.gov/pubmed/19670917 Drug Saf. 2009;32(9):775-85. Low-energy femoral fractures associated with the long-term use of bisphosphonates: a case series from a Swiss university hospital. Ing-Lorenzini K, Desmeules J, Plachta O, Suva D, Dayer P, Peter R.

(38) http://www.ncbi.nlm.nih.gov/pubmed/18448990
J Orthop Trauma. 2008 May-Jun;22(5):346-50. Low-energy femoral shaft fractures associated with alendronate use. Neviaser AS, Lane JM, Lenart BA, Edobor-Osula F, Lorich DG.
Hospital for Special Surgery, New York, NY, USA.

(39) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2823197/
Acta Orthop. 2009 August 7; 80(4): 413–415.  Incidence of stress fractures of the femoral shaft in women treated with bisphosphonate  Jörg Schilcher and Per Aspenberg  Department of Orthopedics, AIM/IKE, Faculty of Health Science, Linköping University, Linköping, Sweden

(40) http://www.ncbi.nlm.nih.gov/pubmed/18222447
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(41) http://www.nejm.org/doi/full/10.1056/NEJMc0707493 Correspondence. Atypical Fractures of the Femoral Diaphysis in Postmenopausal Women Taking Alendronate  N Engl J Med 2008; 358:1304-1306 March 20, 2008 Brett A. Lenart, B.S. Dean G. Lorich, M.D. Joseph M. Lane, M.D. Weill Cornell Medical College, New York, NY 10021

Author Dr Dach

Jeffrey Dach MD