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

Sitting in my office last week, 51 year old Jane Smith told me her story.  She had seen a TV commercial which showed the actress, Sally Field, suggesting to everyone to have their bones checked for osteoporosis.  This prompted a doctor's visit and a DEXA bone scan which showed a T score of minus 2.3.  Even though Janet did not have osteoporosis, and has never had an osteoporotic fracture, she was neverthless prescribed a bisphosphonate drug to "prevent" osteoporosis.   The most commonly used drugs in this class Fosamax.,  Boniva, and Actonel which are all Bisphosphonates.   Jane has no risk factors, doesn't smoke or drink, avoids soda pop and caffeine, exercises regularly, eats organic food and takes a handful of vitamins each day. Jane informs me that she did an internet search and found out that Fosamax and Actonel cause necrosis of thejaw, bone pain, and she wanted to know if there was a more natural way to increase bone density without drugs. The following information was shared with Jane.
  
Bisphosphonates?

This article will take a closer look at the data and current recommendations for bisphosphonate drugs for osteoporosis.  We will weigh the possible benefits versus the adverse side effects of the bisphosphonate drugs.

Image at left:  is a lateral xray of an end stage osteoporotic thoracic spine with multiple compression fractures. Two of the levels have been injected with acrylic cement (white bands), a procedure called kyphoplasty to strengthen the washed out bones.

What is Primary Prevention and Secondary Prevention ?

The main goal of bisphosphonate drug treatment for osteoporosis is the prevention of hip and vertebral fractures, and the major diagnostic tool is the DEXA bone density scan which is reported as the T-score.

The Secondary prevention group is defined as those women who have T scores less than -2.5 along with existing osteoporotic fractures.  The Primary prevention group is defined as those women who have T scores greater than -2.5 and do not have osteoporotic fractures.  The more severe Osteporosis is defined as a T-score less than -2.5 , and the less severe Osteopenia has a T score of greater than -2.5.
 
The current NICE guidelines recommend the bisphosphonate drugs for Secondary prevention of osteoporotic fracture in women who already have osteoporosis (T-score less than -2.5), and have a history of osteoporotic fracture. (21)  NICE = National Institute for Clinical Excellence.

Bisphosphonates Not Recommended for Primary Prevention

For primary prevention of osteoporotic fracture in women with osteopenia, (T-score greater than -2.5), the use of bisphosphonates is NOT recommended because the Fracture Intervention Trial (FIT) data shows increased fracture rate with bisphosphonates. (15)  This is discussed in detail below.

Failure of Treatment

What if the osteoporotic woman continues to fracture while on bisphosphonate drugs? This is called failure of treatment and there are no current guidelines for this scenario.(22).  Susan Ott MD, however, would then recommend a trial of intermittent PTH.(30)

FDA Issues Alert About Severe Bone Pain from Bisphosphonates

Two months ago, Jan 7 2008, the FDA issued an alert highlighting “the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. “ which may be overlooked, delaying diagnosis, prolonging pain requiring pain medications.(1)  Could this pain be caused by microdamage and cracks in the bones?(2)  

Adverse Side Effects Posted on Message Message Boards

Here is the link to a Message Board with 613 adverse side effect  messages for Fosamax  (3)  There are also 530 adverse side effect messages posted for Actonel.(3A). 

The Adverse Side Effect of Bis- Fossy Jaw (4)

A number of reports have found similarities between bisphosphonate induced avascular necrosis of the jaw and a 19th century occupational disease in workers in match factories from inhalation of white phosphorus. Not only these workers have necrosis of the jaw, they also had systemic weakness of all other bones. 

“There is evidence that occupational exposure to white phosphorus affects bones other than those in the jaw; this implies a systemic effect for inhaled white phosphorus. Two middle-aged men occupationally exposed to white phosphorus for 20-30 years had a history of breaking their femurs in accidents not normally expected to result in breakage of bones (Dearden 1899).”(10)(5)-(11) 

Avascular Necrosis of the Jaw

Some argue that the adverse side effect of jaw necrosis is seen exclusively in cancer patients receiving intravenous bisphosphonates, rather than in those who take the oral form of the medication.    However, there are also cases reported in the medical literature of Jaw Necrosis after dental procedures in patients taking the oral bisphosphonate tablets.  For this reason, Bisphosphonates are under litigation for Jaw Necrosis as discussed in my previous article, Protect Your Family from Bad Drugs by Jeffrey Dach MD. (41)  The issue raised here is: Why is jaw necrosis happening at all? To me, this raises the serious concern that whole class of bisphosphonate drugs disturb the underlying physiology of bone formation.  

Toulouse Lautrec's Disease

My previous article, Fosamax, Actonel, Osteoporosis and Toulouse Lautrec, discussed reports of spontaneous fractures in patients on bisphosphonates and the similarity with pycnodysostosis, a genetic disease of the osteoclast bone cells.(24)  These are unusual non-healing fractures of the mid femur indicating weak bone matrix.  Toulouse Lautrec suffered this exact type of femur fracture bilaterally at a young age.

Avascular Necrosis of the Femoral Head from Bisphosphonates

Another new report is the revelation of a tripled incidence of avascular necrosis of the femoral head in women taking Fosamax. (13)  Again, the issue is why should this adverse event be increased at all?  To me it suggested deranged or abnormal bone physiology as a result of drug treatment.

P and G  Hiding Data, Again?

According to a correspondence letter by Paul C. Royce, M.D., Ph.D. (31), Proctor and Gamble, the maker of the bisphosphonate Actonel, omitted  data in a large clinical trial that they sponsored whose lead author was McClung.  

The McClung data included 9,331 elderly women with low bone density. P&G announced that their bisphosphonate risedronate (Actonel) increased bone mineral density by one per cent ( 1%).  However, when they conducted their follow-up phase of the trial,  the information about the outcome of 3,324 women ( slightly over a third of the trial subjects), was not made available.  This data was omitted from publication and peer review in the final article.(32)  The whistle blower, Aubrey Blumson has previously documented extensive scientific misconduct by this same company, Proctor and Gamble, the soap company that makes Actonel. (17) 

Dr. Cummings did not hide the data in his 1998 JAMA FIT article.

Why Does Fracture Rate Go Up WIth Fosamax in Osteopenia? 

Although Fosamax and Actonel reduces fracture rates modestly (1-2% absolute) in elderly women with severe osteoporosis and compression fractures, why does fosamax increase fracture rates in women with osteopenia (T greater than -2.5) ? 

Fosamax is supposed to make bones stronger, not weaker.  Dr. Cummings' original FIT JAMA article in 1998 did not explain why hip fracture rates went up 84% for fosamax in women with osteopenia (a less severe than osteoporosis with T score greater than -2.5)

In a study published in JAMA in 1998, for example, women with an average age of 68 and a T score of - 2.5 or less who took Fosamax for four years were 56 percent less likely to suffer a hip fracture than women in the control group.  This sounds like very good news for women with osteoporosis, but how many hip fractures were really prevented?  With no drug therapy at all, women with osteoporosis had a 99.5 percent chance of making it through each year without a hip fracture -- pretty good odds.  With drug therapy, their odds improved to 99.8 percent. In other words, taking the drugs decreased their risk of hip fracture from 0.5 percent per year to 0.2 percent per year.  This tiny decrease in absolute risk translates into the study's reported 56 percent reduction in relative risk.  The bottom line is that 81 women with osteoporosis have to take Fosamax for 4.2 years, at a cost of more than $300,000, to prevent one hip fracture. (This benefit does not include a reduction of less serious fractures, including wrist and vertebral fractures. Most vertebral fractures cause no symptoms.)

 

What about using these drugs to prevent osteoporosis?  The study of Fosamax published in JAMA in 1998 (mentioned earlier) also included women with osteopenia.   Did Fosamax reduce their risk of fracture? The results show that the risk of hip fractures actually went up 84 percent with Fosamax treatment.* The risk of wrist fractures increased by about 50 percent.(25)

Effect of Alendronate on Risk of Fracture in Women With Low Bone Density but Without Vertebral Fractures  Results From the Fracture Intervention Trial (15)

Steven R. Cummings, MD; Dennis M. Black, PhD; Desmond E. Thompson, PhD; William B. Applegate, MD; Elizabeth Barrett-Connor, MD; Thomas A. Musliner, MD; Lisa Palermo, MA; Ronald Prineas, MD; Susan M. Rubin, MA; Jean C. Scott, PhD; Thomas Vogt, MD, MPH; Robert Wallace, MD; A. John Yates, MD; Andrea Z. LaCroix, PhD; for the Fracture Intervention Trial Research Group  ,  JAMA. 1998;280:2077-2082.

HIP Fractures Reduced for 56% for Osteoporosis,
But Increased 84% in Osteopenia

Alendronate (Fosamax) reduced the risk of hip fractures by 56% among women with a femoral neck T score of -2.5 or less: 18 (2.2%) in the placebo group vs 8 (1.0%) in the alendronate group (RH, 0.44; 95% CI, 0.18-0.97; placebo-treatment difference, 1.2%; NNT, 81).

There was no reduction in risk among those whose femoral neck T scores were more than -2.5: 6 (0.4%) in the placebo group vs 11 (0.8%) in the alendronate group (RH, 1.84; 95% CI, 0.70-5.36).

Fosamax Treatment Increases Wrist Fractures by 53% for T score above -2.5

The effect of alendronate on the risk of wrist fractures also varied by baseline femoral neck BMD. There was no significant reduction among women with a T score of -2.5 or less: 38 (4.7%) in the placebo and 34 (4.2%) in the alendronate group (RH, 0.88; 95% CI, 0.55-1.40).

Similarly, we observed no reduction in risk among women with T scores of -2.0 to -2.5: 20 (2.8%) in the placebo group vs 27 (3.7%) in the alendronate group (RH, 1.33; 95% CI, 0.75-2.4). Among those whose femoral neck T scores were more than -2.0, more fractures occurred in the treatment group (n = 22, 3.3%) than in the placebo group (n = 12, 1.7%; RH, 1.9; 95% CI, 1.0-4.0; placebo-treatment difference, 1.6%).

For T score greater than -2.5 (49 fxs alendronate vs 32 fxs placebo)  = RH 1.53

(15) (16)

The Osteopenia Group Has No Benefit from the Drug

The FIT data is very clear.  For the Osteopenia group, wrist fractures are clearly increased by Fosamax treatment, and there is an increase in Hip fractures in the osteopsenia group.  Why should there be increased fractures in any group.  This revelation indicates a serious problem which has been ignored, and suggests there is something seriously wrong with the bone physiology of bisphosphonate drug treatment. 

Spontaneous Mid Femur Fractures on Bisphosphonates

Reports by Odvina(28) of spontaneous femur fractures and similarities with Pycnodysostosis, Toulous Lautrec's rare genetic bone disease,  raises even more questions about the bisphosphonate class of drugs.  The report by Odvina of spontaneous mid femur fractures has been duplicated by Goh with his 2007 report of subtrochanteric femur fractures with minimal trauma in women on long term fosamax. (29).  A third report of spontaneous fractures in menopausal women on fosamax was just reported in the New England Journal  March 20, 2008 by Dr. Joseph M Lane.  (42)  How many Menopausal women must suffer spontaneous mid femur fractures before we declare enough is enough and ban this entire class of drugs?

Why is Sally Field Misleading Millions of Women with TV Ads?

Sally Field stood up at the Academy Awards and made an Anti-War statement (which was censored). Does Sally Field know that her paid television ads for Boniva are targeting women with Osteopenia? If Sally knew the above information about bisphosphonates, would Sally Field again stand up, and tell women that Boniva, like all bisphosphonates,  INCREASES fracture rates for hip and wrist in women with Osteopenia (a less severe form of Osteoporosis with T score greater than -2.5). 

Perhaps Sally would like to explain this to John Dingle's House Committee which wil soon be asking questions about Sally's role with Boniva. (37)
 

For example does Sally really have Osteoporosis with a T score less than -2.5? Or does Sally have the less severe Osteopenia with a T score of greater than -2.5.  Why is Sally taking a bisphosphonate even though she has never had an osteoporotic fracture?  Is Sally taking the Boniva drug for prevention?  Why is Sally Field misleading millions of women (with osteopenia) into taking a drug for prevention of osteoporosis when this will clearly harm them by causing increased fracture rate in their group?  This is another good example of why all Direct-to-Consumer Ads, including Sally's  for bisphosphonates, should be banned. (33)(34)(35)(36)

You can contact John Dingle's Committee at this address, and send a letter of concern about the Boniva television ads which target millions of women with osteopenia.(37)  Mr. Dingle's committee has been investigating celebrity drug ads, such as the Jarvik Lipitor ads, and the Vytorin ads.  The Boniva ads are next.

Send your letter to: 
the Honorable John Dingle, Dean of the House of Representatives,
Chairman of the Committee on Energy and Commerce
2328 Rayburn House Office Building
Washington, DC 20515,  (202) 225-4071

Use this link to contact your representative and send an email or letter of concern. (38) https://forms.house.gov/wyr/welcome.shtml

Disease Mongering or Prevention?

A January 2008 BMJ report by Pablo Alonso-Coello makes the case that the drug industry's bisphosphonate marketing programs is actually a form of disease mongering designed to convince osteopenic women to take bisphosphonates even though there is no evidence of benefit for this group.(18) 

In order to obtain informed consent, all women offered these drugs must be informed  about potential risks and benefits, and then be allowed to make their own decision.  I have found that most women with osteopenia who are aware of this information will decline the bisphosphonates. 
  
Aubrey Blumsohn says:

”These are good drugs when used appropriately. However, I'm not sure that the risks and benefits (and possibility of unknown risk) have been appropriately weighed so as to allow correct, cost effective and safe targeting of therapy. We know nothing about the long term (30 year) benefits or risks of bisphosphonates.”(17) 

Dr. Blumsohn was the lead researcher in an Actonel study in Sheffield England.  The data was blinded, and the paper published by ghost writers hired by P and G without Blumsohn seeing the actual unblinded data.  When Blumsohn objected, he  was fired from his job at the university. (40)

Susan Ott, MD at the University of Washington Says:

Many physicians do not even consider the possibility that bisphosphonates could have some adverse effects on the bone. The interesting results described in the paper by Odvina et al. along with reports from animal studies and biopsy data from clinical trials, should heighten awareness of the actions of these drugs. The profound suppression of bone formation could have negative effects that occur after long-term accumulation in the skeleton. There is no good surrogate for the passage of time, and it will be at least a decade before we have any data about whether the potential negative effects would ever predominate over the known positive effects. Until then, bisphosphonates should be used carefully. Men and women with established osteoporosis have a high risk of fragility fractures within the 5 yr after diagnosis, and in these cases the proven benefits outweigh the theoretical long-term risks. These benefits, however, are proven only for the first 5 yr. I believe the current evidence suggests that bisphosphonates should be stopped after 5 yr. Those patients who remain at a high risk of fractures or who have had fractures despite bisphosphonate therapy could be considered for treatment with intermittent PTH. (30)

Preventing the Fall is May be More Important Than the Osteoporosis Drug

My grandmother (left image self portrait), who lived to be 100, had severe osteoporosis with many spinal compression fractures and rib deformities, yet she never had a hip fracture because she never sustained a fall. A recent BMJ article has called for a more logical approach, shifting away from osteoporosis drugs to instead, preventing the falls that produce the deadly hip fractures.(23)  

For more on the effects of bisphosphonates, and the similarities with Toulouse Lautrec's Disease (pycnodysostosis) see my previous article.(19)  

Above image, Eve Garrison Self Portrait, my grandmother the artist, lived to be 100.

Reverse Osteoporosis Naturally WIthout Drugs

Perhaps the most important concept to reverse osteoporosis is acid base balance which is described in this article, Acid-Alkaline Balance and Its Effect on Bone Health by Susan E. Brown, Ph.D., CCN, and Russell Jaffe, MD, Ph.D., CCN, International Journal of Integrative Medicine, Vol. 2, No. 6 Nov/Dec 2000.(39)

For more information on natural ways to improve bones with diet, lifestyle modifications and supplements to reverse osteoporosis, see my web page here. (24)

Jeffrey Dach  MD
4700 Sheridan Suite T
Hollywood FL 33021
954-983-1443
http://.wwwdrdach.com/


References

(1) http://www.fda.gov/cder/drug/InfoSheets/HCP/bisphosphonatesHCP.htm
FDA: Alert , Information for Healthcare Professionals
Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa)

(2) http://www.medicine.indiana.edu/news_releases/viewRelease.php4?art=552
September 15, 2006 Skeletal Microdamage Stable After First Year, Study Shows
PHILADELPHIA — (Sept. 15, 2006) Skeletal microdamage resulting from bisphosphonate treatment may be maximal during the first year of treatment, and not continue to accumulate with longer periods of treatment, according to new research being presented today at the 28th Annual Meeting of the American Society for Bone and Mineral Research (ASBMR).

Bisphosphonates are the most common class of drugs used for the treatment of osteoporosis because of their demonstrated effect on fracture reduction but the incidence of microcracks - small cracks in the skeleton - has been shown to increase with bisphosphonate treatment. This has led to some concerns regarding the potential long-term adverse effects of these agents. This study shows that the continued use of alendronate (a bisphosphonate) is not associated with continued accumulation of microdamage.  Matt R. Allen, Ph.D., assistant research professor, and David B. Burr, Ph.D., chairman, both from the Indiana University School of Medicine Department of Anatomy and Cell Biology, Indianapolis, IN, evaluated the effects of alendronate in one-year-old female beagles.

(3) http://www.askapatient.com/viewrating.asp?drug=20560&name=FOSAMAX
Message Board  adverse side effects of Fosamax (600 messages)

(3A) http://www.askapatient.com/viewratings.asp?drug=20835&name=ACTONEL&sort=age
Message Board with 530 messages about adverse effects of Actonel.

(4) http://scholar.google.com/scholar?hl=en&lr=&q=phossy+jaw&btnG=Search
Fossy Jaw list of articles

(5) http://www.nzma.org.nz/journal/119-1246/2341/
Journal of the New Zealand Medical Association, 01-December-2006, Vol 119 No 1246
Jaw osteonecrosis associated with bisphosphonates
Jodie Battley, Sisira Jayathissa, Eric Seneviratne

(6) http://www.annals.org/cgi/reprint/144/10/753.pdf
Systematic Review: Bisphosphonates and Osteonecrosis of the Jaws
Sook-Bin Woo, DMD; John W. Hellstein, DDS, MS; and John R. Kalmar, DMD, PhD

(7) http://www.annals.org/cgi/eletters/144/10/753
Bisphosphonates can cause hypocalcemia and vitamin D deficiency.

(8)
Berthold HK, Diel IJ, Gouni-Berthold I. Phossy jaw revisited -- do bisphosphonates cause "bisphossy jaws"? Drug Safety. 2004;27:92

(9) http://en.wikipedia.org/wiki/Phossy_jaw
Wikipedia Phossy Jaw

(10) http://www.atsdr.cdc.gov/toxprofiles/tp103-c2.pdf
There is evidence that occupational exposure to white phosphorus affects bones other than those in the jaw; this implies a systemic effect for inhaled white phosphorus.

Two middle-aged men occupationally exposed to white phosphorus for 20-30 years had a history of breaking their femurs in accidents not normally expected to result in breakage of bones (Dearden 1899).

 One man had broken the right and left femurs on two separate occasions by “tripping over a board,” while the other broke the right femur by “stumbling down a single step,” and the left femur in “just as simple a manner.”

 Examination of bone from the fingertip of one of the two workers indicated an increased “relative proportion of phosphoric acid to lime” compared to healthy bone by nearly 1%.

Thus, occupational exposure to white phosphorus may change the composition of bone tissue, decreasing the bones ability to resist fracture; however, the information reported in this study is insufficient to definitively attribute the observed effects to occupational exposure to white phosphorus.

(11) http://www.mja.com.au/public/issues/183_03_010805/letters_010805_fm-2.html
Letters, Bisphosphonates and osteonecrosis: analogy to phossy jaw  MJA 2005; 183 (3): 163-164

(12) http://www.mja.com.au/public/issues/182_08_180405/pur10144_fm.html
ADRAC Report Bisphosphonates and osteonecrosis of the jaw Patrick M Purcell and Ian W Boyd MJA 2005; 182 (8): 417-418

(13) http://www.jrheum.com/abstracts/abstracts08/13/0120.html
Use of Oral Bisphosphonates and the Risk of Aseptic Osteonecrosis: A Nested Case-Control Study Oct 2007 MAHYAR ETMINAN, KEVIN AMINZADEH, IAN R. MATTHEW, and JAMES M. BROPHY ABSTRACT.

Objective. To determine whether use of oral bisphosphonates is associated with an increased risk of aseptic osteonecrosis (AON) among a cohort of elderly cardiovascular patients.

Methods. We conducted a nested case-control study within a previously defined cardiovascular cohort of elderly Quebec patients using linked administrative health databases. Cases were defined as those with the diagnosis of hospitalization secondary to AON at a nonspecified site. For each case, 10 controls were randomly selected and matched to the cases by age, calendar time, and length of followup. The main outcome measure was the risk ratio (RR) of AON among ever-users of oral bisphosphonates compared to that among nonusers. 

Results. The initial cohort consisted of 87,837 subjects. In the primary analysis, the adjusted RR for AON among bisphosphonate users was 2.87 (95% CI 1.71-5.05). The adjusted RR for alendronate, etidronate, and risedronate were 2.87 (95% CI 1.46-5.67), 2.43 (95% CI 1.05-5.62), and 3.34 (95% CI 1.04-10.67), respectively.

Conclusion. In this cohort of elderly cardiovascular patients, an association was observed between oral bisphosphonate use and aseptic osteonecrosis. Further research into this putative association is required. (J Rheumatol First Release Jan 15 2008)

(14) http://content.nejm.org/cgi/content/full/344/5/333 
McClung MR, Geusens P, Miller PD, Zippel H, Bensen WG, Roux C, Adami S, Fogelman I, Diamond T, Eastell R, Meunier PJ, Reginster JY. Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. New England Journal of Medicine Feb 1, 2001; 344: 333 - 340.   full text of article

(15) http://jama.ama-assn.org/cgi/content/full/280/24/2077
Effect of Alendronate on Risk of Fracture in Women With Low Bone Density but Without Vertebral Fractures  Results From the Fracture Intervention Trial

 (16) http://jama.ama-assn.org/cgi/content/full/280/24/2119
Bone Mass, Bone Fragility, and the Decision to Treat Robert P. Heaney, MD JAMA. 1998;280:2119-2120.

(17)
http://scientific-misconduct.blogspot.com/2008/01/bisphosphonate-induced-pain-in.html
Bisphosphonate induced pain in osteoporosis - statistical analysis discovered,  Aubrey Blumson

(18) http://www.bmj.com/cgi/content/full/336/7636/126
BMJ  2008;336:126-129 (19 January), doi:10.1136/bmj.39435.656250.AD
Drugs for pre-osteoporosis: prevention or disease mongering? Pablo Alonso-Coello, family practitioner1, Alberto López García-Franco, family practitioner2, Gordon Guyatt, professor3, Ray Moynihan, conjoint lecturer

(19) http://jeffreydach.com/2007/05/14/fosamax-actonel-osteoporosis-and-toulouse-lautrec-by-jeffrey-dach-md.aspx
Fosamax, Actonel, Osteoporosis and Toulouse Lautrec by Jeffrey Dach M.D.

(20)
http://www.keele.ac.uk/schools/pharm/MTRAC/ProductInfo/verdicts/R/Risedronate%20osteo.pdf MTRAC information on Actonel

(21) http://www.nice.org.uk/nicemedia/pdf/TA087guidance.pdf
NICE guidance recommends bisphosphonates be used as secondary prevention for postmenopausal women who present with osteoporotic fragility fracture

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