Fosamax Study Denies Link with Femur Fractures

Posted on March 26, 2015

 

Fosamax Study Denies  Link with Femur Fractures
by Jeffrey Dach MD

A recent NEJM article by Dennis Black MD denying a link between Fosamax and spontaneous mid-femur fractures has many doctors raising their eyebrows.  Firstly, there is the problem of conflict of interest.  The study was funded by Fosamax maker, Merck, and the authors are all on Merck’s payroll.  Left Image: Spontaneous mid femur fracture courtesy of Jennifer P. Schneider, MD, PhD (7).


Secondly, a number of flaws in the study are brought out by Dr Elizabeth Shane who says in a NEJM Editorial: No Xray data was presented, although every patient with a fracture had xrays.  The women were on Fosamax for shorter time and lower dosage required to generate the femur fractures. The statistics of the study was questioned.


Left image fosamax induced fractures courtesy of Dr Lane Nejm. Radiographs of Spontaneous Fractures of the Femoral Shaft Showing the “Simple with Thick Cortices” Pattern.

In spite of Dr Black’s reassuring report, Dr Elizabeth Shane still recommends a drug holiday. This is a polite way of saying, “STOP THE DRUG”.  Dr Shane says: “it is reasonable to consider drug holidays “. 

My Advice:  My advice is to stay away from bisphosphonate drugs. These are “Bad Drugs” which should never have been approved for human use.


More Questions:

I have a few more questions and comments about Dr Black’s NEJM report.

1) The patient data was not stratified according to T score.  The FIT trial showed increased fracture rates in patients on Fosamax with T scores greater than -2.5.  Fosamax doubled the hip fracture rate in this group (T score above -2.5) from 6 to 11.

2) Although there were 284 hip fractures, 135 were excluded from the data for various reaons, and only 12 were accepted as spontaneous mid-femur fractures.  Whenever data is excluded from a data set, this arouses suspicion and a red flag of possible data manipulation.

Another question:  since there was no Xray data, how can the fractures be reviewed and excluded without this?  If there was Xray review, then why wasn’t this data included in the study?

3) Why do the results of Dr Dennis Black contrast with the many reported case series on Fosamax induced spontaneous femur fractures from Joseph Lane, Odvina and Goh (and many others).
Dr Black’s results run opposite to the reported experience of the medical community.  Physicans are seeing and reporting more cases of atypical femur fractures on Fosamax.   These are spontaneous fractures with no trauma indicating underlying pathologic bone formation.  We never saw these before the fosamax era.

4) Why do the results of Dr Dennis Black contrast with bone histology studies that show abnormal bone formation on Fosamax, reporting “microdamage accumulation and reduced some mechanical properties of bone”.

5) Why are these spontaneous mid-femur fractures happening at all ?  Doesn’t this indicate a severe problem with the underlying bone physiology?  The bisphosphonate drug is producing abnormal, pathological bone demonstrated on histology slides.  Dr Black’s report does not address this question.
 
Osteo-Necrosis of the Jaw Reported by Dentists

6) What about reports of a link with Osteonecrosis of the Jaw, another example of fosamax disturbing bone physiology, making the bones weaker, not stronger.  Dr Black’s report does not address this issue. Left Image : Radiograph of bisphosphonate-related osteonecrotic lesion at extraction site of tooth #18. Lesion extends to the apices of adjacent tooth #19. courtesy of AFP editorial.

Bottom line: Dr Black’s report is unconvincing.  Especially unconvinced are the increasing numbers of women presenting to the orthopedic surgeons with spontaneous femur fractures on fosamax.  These fractures are devastating and do not heal.  My advice is to stay away from bisphosphonate drugs. These are “Bad Drugs” which should never have been approved for human use.  

Effective Natural Treatments for Osteoporosis

Number one: Avoid the bisphosphonate drugs.  These are “Bad Drugs”..

This is the list to avoid:
Alendronate (Fosamax)
Risedronate (Actonel)
Ibandronate (Boniva)
Zoledronic acid (Reclast)

Number two: Use a nutritional supplement program including a full range of  nutrients to build strong bone, Vitamin K1 and K2, Vitamin D3, Calcium, Magnesium, Boron, Strontium, trace minerals, vitamin C, silica, etc.

Number three: If you are in the post-menopause age group, consider bioidentical hormone replacement. Bone loss is directly caused by post-menopausal hormone deficiency.  A robust bioidentical  hormone replacement program maintains healthy muscle mass and bone density.

Number four: Test for other common causes of osteoporosis such as gluten sensitivity and calcium malabsorption.  Magnesium deficiency , and calcium malabsorption may be caused by gluten sensitivity, gluten enteropathy and celiac disease.  Our routine lab panel includes testing for gluten sensitively.

Number Five: Lifestyle Changes: Modify Diet to alkaline diet  Use the helpful food chart in this article: Acid_Alkaline Balance and Its Effect on Bone Health by Susan E Brown Russell Jaffe.  Eliminate foods which cause osteoporosis such as phosphate containing colas, eliminate cigarette smoking, etc. Make sure you have a good exercise program to maintain good muscle mass.  For more on this, see my article on Reverse Osteoporosis Naturally Without Drugs.
This article is part two, for part one click here.

Articles with Related Content :

FDA Says Osteoporosis Drugs Cause Femur Fractures
Fosamax, a Bad Drug in Litigation
Fosamax, Osteoporosis and Toulouse Lautrec
Fosamax induced Femur Fractures More Bad News
Bisphosphonates for Osteoporosis, A Closer Look at the Data
Osteoporosis Drugs Cause Osteo-Necrosis of the Jaw
Links and References


1) http://content.nejm.org/cgi/content/full/NEJMe1003064
Evolving Data about Subtrochanteric Fractures and Bisphosphonates Elizabeth Shane, M.D. – it is reasonable to consider drug holidays with careful observation for most patients with osteoporosis who are receiving long-term therapy
2) http://content.nejm.org/cgi/content/full/NEJMoa1001086
Bisphosphonates and Fractures of the Subtrochanteric or Diaphyseal Femur Dennis M. Black, Ph.D., Michael P. Kelly, M.D., Harry K. Genant, M.D., Lisa Palermo, M.A., Richard Eastell, M.D., Christina Bucci-Rechtweg, M.D., Jane Cauley, Ph.D., Ping Chung Leung, M.D., Steven Boonen, M.D., Ph.D., Arthur Santora, M.D., Anne de Papp, M.D., Douglas C. Bauer, M.D., for the Fracture Intervention Trial and HORIZON Pivotal Fracture Trial Steering Committees Conclusions The occurrence of fracture of the subtrochanteric or diaphyseal femur was very rare, even among women who had been treated with bisphosphonates for as long as 10 years. There was no significant increase in risk associated with bisphosphonate use, but the study was underpowered for definitive conclusions.
Conflict-of-Interest?
Dr. Black reports to the NEJM that he is receiving grants (to UCSF) from Merck, Novartis, Amgen, and Roche and travel reimbursements from Merck and Novartis, who also supported the research. The study was sponsored by Merck and Novartis. Several other authors work for the companies, while others consult and receive compensation for their work from the makers of bisphosphonates.
3) http://courses.washington.edu/bonephys/opsubtroch.html
Subtrochanteric fractures- Susan Ott md
Reports of Spontaneous Femur Fractures
4) http://content.nejm.org/cgi/content/full/358/12/1304
NEJM V358:1304-1306  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
5) http://jcem.endojournals.org/cgi/content/abstract/90/3/1294
Odvina CV, Zerwekh JE, Rao DS, Maalouf N, Gottschalk FA, Pak CY. Severely suppressed bone turnover: a potential complication of alendronate therapy. J Clin Endocrinol Metab 2005;90:1294-1301.
6) http://www.ncbi.nlm.nih.gov/pubmed/17356148
Goh SK, Yang KY, Koh JS, et al. Subtrochanteric insufficiency fractures in patients on alendronate therapy: a caution.
J Bone Joint Surg Br 2007;89:349-353.
More Reports
7)  Schneider, Jennifer P. “Bisphosphonates and low-impact femoral fractures: current evidence on alendronate-fracture risk.” Geriatrics 64.1 (2009): 18-23. Bisphosphonates Femur Fracture Jennifer P Schneider January 2006 Volume 61 Number 1 Geriatrics
8) http://www.ncbi.nlm.nih.gov/pubmed/18222447
An emerging pattern of subtrochanteric stress fractures: A long-term complication of alendronate therapy?§ Ernest Beng Kee Kweka,*, Seo Kiat Goh a, Joyce Suang Bee Koh a,
Meng Ai Png b, Tet Sen Howe Department of Orthopaedic Surgery, Singapore General Hospital, Outram Road, Singapore 169608, Singapore Department of Diagnostic Radiology, Singapore General Hospital, Outram Road, Singapore 169608, Singapore August 2007
Injury, Int. J. Care Injured (2008) 39, 224—231
9) http://www.jenniferschneider.com/articles/Bisphosphonates.pdf
Bisphosphonates and low-impact femoral fractures: Current evidence on alendronate-fracture risk Jennifer P. Schneider, MD, PhD
10) http://www.ncbi.nlm.nih.gov/pubmed/19884427
J Bone Joint Surg Am. 2009 Nov;91(11):2556-61.
Bilateral low-energy simultaneous or sequential femoral fractures in patients on long-term alendronate therapy. Capeci CM, Tejwani NC.Department of Orthopaedic Surgery, New York University Hospital for Joint Diseases, 301 East 17th Street, Suite 1401, New York, NY 10003, USA.
11) http://www.ncbi.nlm.nih.gov/pubmed/19198962
Clin Orthop Relat Res. 2009 Jul;467(7):1921-6. Epub 2009 Feb 6.
Case reports: two femoral insufficiency fractures after long-term alendronate therapy.  Sayed-Noor AS, Sjödén GO.Department of Orthopaedic Surgery, Sundsvall Hospital, 851 86 Sundsvall, Sweden.
12) http://www.ncbi.nlm.nih.gov/pubmed/19670917
Drug Saf. 2009;32(9):775-85. doi: 10.2165/00002018-200932090-00002.
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.
Division of Clinical Pharmacology and Toxicology, Regional Pharmacovigilance Centre, University Hospitals of Geneva, Geneva, Switzerland.
13) http://www.ncbi.nlm.nih.gov/pubmed/20020334
Clin Orthop Relat Res. 2009 Dec 18. [Epub ahead of print]
Case Reports: Subtrochanteric Femoral Stress Fractures after Prolonged Alendronate  Therapy.  Cermak K, Shumelinsky F, Alexiou J, Gebhart MJ.
Department of Orthopedic Surgery, Institut Jules Bordet, Université Libre de Bruxelles, 1 rue Heger-Bordet, 1000, Brussels, Belgium,
Bone Histology studies
14) http://www3.interscience.wiley.com/journal/123292394/abstract
Suppressed Bone Turnover by Bisphosphonates Increases Microdamage Accumulation and Reduces Some Biomechanical Properties in Dog Rib , Journal of Bone and Mineral Research Volume 15 Issue 4, Pages 613 – 620 Published Online: 18 Feb 2010  by Tasuku Mashiba 1, Toru Hirano 1, Charles H. Turner 1, Mark R. Forwood 2, C. Conrad Johnston 3, David B. Burr, Ph.D. 1 *
1Departments of Anatomy and Cell Biology, and Orthopaedic Surgery, Biomechanics and Biomaterials Research Center, Indiana University School of Medicine, Indianapolis
It has been hypothesized that suppression of bone remodeling allows microdamage to accumulate, leading to increased bone fragility. This study evaluated the effects of reduced bone turnover produced by bisphosphonates on microdamage accumulation and biomechanical properties of cortical bone in the dog rib. Thirty-six female beagles, 1-2 years old, were divided into three groups. The control group (CNT) was treated daily for 12 months with saline vehicle. The remaining two groups were treated daily with risedronate (RIS) at a dose of 0.5 mg/kg per day or alendronate (ALN) at 1.0 mg/kg per day orally. After sacrifice, the right ninth rib was assigned to cortical histomorphometry or microdamage analysis. The left ninth rib was tested to failure in three-point bending. Total cross-sectional bone area was significantly increased in both RIS and ALN compared with CNT, whereas cortical area did not differ significantly among groups. One-year treatment with RIS or ALN significantly suppressed intracortical remodeling (RIS, 53%; ALN, 68%) without impairment of mineralization and significantly increased microdamage accumulation in both RIS (155%) and ALN (322%) compared with CNT. Although bone strength and stiffness were not significantly affected by the treatments, bone toughness declined significantly in ALN (20%). Regression analysis showed a significant nonlinear relationship between suppressed intracortical bone remodeling and microdamage accumulation as well as a significant linear relationship between microdamage accumulation and reduced toughness. This study showed that suppression of bone turnover by high doses of bisphosphonates is associated with microdamage accumulation and reduced some mechanical properties of bone.
15) http://www.annals.org/content/144/10/753.abstract
Systematic Review: Bisphosphonates and Osteonecrosis of the Jaws
Sook-Bin Woo, DMD; John W. Hellstein, DDS, MS; and John R. Kalmar, DMD, PhD.  Annals of Internal Med May 16, 2006 vol. 144 no. 10 753-761
16) Bisphosphonate-Related Osteonecrosis of the Jaw in Patients with Osteoporosis by CHRISTINE HENG, DDS, MPH, U.S. Public Health Service, Federal Correctional Institution, Danbury, Connecticut   VICTOR M. BADNER, DMD, MPH, and TASIOS G. VAKKAS, DDS, MD, Jacobi Medical Center, Bronx, New York  ROSEMARY JOHNSON, APRN, C-ANP, MSN, U.S. Public Health Service, Federal Correctional Institution, Danbury, Connecticut  YVON YEO, PharmD, Stamford Hospital, Stamford, Connecticut  Am Fam Physician. 2012 Jun 15;85(12):1134-1141.
17) more on Bisphosphonate related osteonecrosis of jaw.
18) Acid_Alkaline Balance and Its Effect on Bone Health by Susan E Brown Russell Jaffe International Journal of Integrative Medicine 2000  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

Jeffrey Dach MD
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Fosamax, Actonel, Osteoporosis and Toulouse Lautrec by Jeffrey Dach M.D.

Fosamax, Actonel, Osteoporosis and Toulouse Lautrec by Jeffrey Dach M.D.

Viewing Osteoporotic Compression Fractures All Day

While working as a radiologist for 25 years, a large part of my day was spent reading X-rays of osteoporotic compression fractures of the spine, which was quite common.  These fractures typically involve the mid thoracic spine causing loss of height and curvature of the spine, and considerable pain. 

Left Image: Dexa scan for Osteoporosis courtesy of wikimedia commons

Vertebroplasty for Compression Fracture - Barbaric?

Working in the hospital over the years, I saw many procedures come and go.  A procedure called vertebroplasty, still in vogue, is used for treatment of compression fractures. This involves injecting glue into the collapsed vertebral body under X-Ray control.(1) Although the procedure may seem somewhat barbaric, it does provide pain relief and restores some height to the collapsed vertebral body. The vertebroplasty procedure was invented in 1984 by the French and introduced into the US by Mary Jensen MD.  The procedure is not for the light hearted because during the actual acrylic glue injection, the acrylic cement may flow into the epidural venous plexus leading to venous thrombosis or pulmonary embolus.(2) The more refined Kyphoplasty version involves inflation of a balloon device to expand the collapsed vertebral body just prior to injection of cement into the cavity. The procedure is quite good at providing some form of pain relief from the compression fractures.

Prevention Makes More Sense


Image Above: Henri Toulouse Lautrec courtesy of wikipedia,
short stature from pycnodysostosis.

On the surface, it might appear callous for the medical system to wait years until thousands of women develop severe osteoporosis with compression fractures, and then intervene with glue injections.  Perhaps some form of prevention would make more sense.  The usual preventive recommendation to take calcium tablets apparently was not effective for these women presenting with osteoporotic compression fractures.  Perhaps the best preventive plan can be found in Russell Jaffe’s article, Acid-Alkaline Balance and its Effect on Bone Health.(3)  Russell Jaffe MD is a charming and humorous fellow who informed our small group of docs at his medical seminar that in the old days he ran a lab at the NIH, and was actually offered the job of Assistant Surgeon General, but he declined the offer after trying it for a day.  He is also the founder of a supplement company called Perque.(15)

Excess Acid in the American Diet Causes Osteoporosis

According to Dr. Jaffe's article, excess acid production from the American diet causes the chronic calcium loss leading to osteoporosis.(3)  The calcium is pulled away from the bones, and used up as a buffering agent for the acids which can then be excreted in the urine.  The solution is to alkalinize the diet, and with the help of alkaline food charts, and pH test strips along with the usual calcium and vitamin supplements, osteoporosis can be arrested and gradually reversed in a process which may take years. I would add that a bio-identical hormone program is also useful for preventing and reversing osteoporosis.

Bisphosphonate Drugs and Toulouse Lautrec's Genetic Bone Defect

For the impatient ones who wish to see a prompt increase in bone density, the FDA approved the bisphosphonate drug Fosamax (alondronate) which was first introduced in 1995. Merck made 3.2 Billion on 22 million Fosamax prescriptions in 2006.  A major drug study, (FIT) the Fracture Intervention Trial, showed lower fracture rates in the drug group.(4)  And it is true that the bisphosphonate drugs will reward the user with a prompt increase in bone density.  The main question remains however, how strong is the bone with the increased density? This is an important question because we know from studies of Toulouse Lautrec that his increased bone density was not stronger, in fact his bones were much weaker leading to spontaneous fracture and jaw necrosis.  This is explained below.



Genetic Bone Disease Duplicates Action of Fosamax

What could fosamax (alondronate) have in common with Toulouse Lautrec, the famous French Impressionist artist?  One day, Toulouse Lautrec's name came up in conversation, and we puzzled over the cause of Lautrec's short stature.  After looking up the question on the internet, we discovered that Toulouse Lautrec’s parents were first cousins giving Toulouse the autosomal recessive genetic disease, pycnodysostosis, which means dense bones. I had seen X-Rays of this bone disease in text books while studying for the radiology board exams, but I have never seen it in actual practice.

Dr. Gelb found Toulouse Lautrec's dense bone disease was caused by a genetic defect in cathepsin K, a protease enzyme of the osteoclast cells responsible for removing and remodeling bone.(5)(6)  Osteoclast cells are bone cells involved in resorption and remodeling of bone. In this disease, the genetically abnormal bone is very dense on xrays, and yet looking under microscopic examination, one sees profound deterioration in trabecular architecture and lamellar arrangement. This is presumably the reason for spontaneous fracture and jaw necrosis which occurs in Lautrec's genetic bone disease, and also occurs as an adverse side effect of the bisphosphonate drugs.(7) 

This osteoclast dysfunction and resulting bone fragility explains why Toulouse had spontaneous fractures of both mid femurs at the age of 12 and 14. The mid-femur fractures never healed properly.  The non-healing mid femur fractures caused Toulouse Lautrec to have short stature, attaining a final height of only four and a half feet.(8)

Left Image: Spontaneous fracture of mid femur in child with pycnodysostosis.  Courtesy of Taylor et al. J Bone Joint Surg Am 60 (8): 1128.

Bisphosphonate Mechanism of Action - Same as Lautrec's Defect

Bisphosphonate drugs (fosamax and actonel) are taken up by osteoclasts, causing disruption of osteoclast activity.  The osteoclasts are bone cells involved in bone resorption and remodeling.  This loss of the osteoclast activity inhibits bone resorption and bone remodeling, tasks otherwise performed by the osteoclasts.(9)  Thus, the bisphosphonate drugs produce a chemical disruption of osteoclast activity same as the genetic disease of Toulouse Lautrec.  The bisphosphonate drugs also produce the same adverse side effects, namely jaw necrosis and spontaneous fracture.

Questions About Long Term Safety of Bisphosphonates

The conventional medical test for bone density is the DEXA bone scan. And, indeed DEXA bone scanning does confirm that bisphoshonate drug treatment increases bone density, and studies such as the FIT (Fracture Intervention Trial) report drug treatments reduce fracture rates in severly osteoporotic women over the short term.  However, Susan Ott, MD  raises questions about the long term safety of bisphosphonates.(10)  Although the bisphosphonate drugs appear to have short term benefits, Dr. Susan Ott speculates that over the long term, after 5 years of use, the drugs cause severe suppression of bone formation, and negative effects such as microdamage and brittleness.

Reports of Spontaneous Fractures

Jennifer P. Schneider, MD, PhD reports a 59-year old previously healthy woman on long-term alendronate.(11) While on a subway train in New York City one morning, the train jolted, and the woman shifted all her weight to one leg, felt a bone snap, and fell to the floor, suffering a spontaneous mid -femur fracture (see right image). In the months following, it became clear that the fracture was not uniting.

Right Image: Spontaneous mid femur fracture courtesy of Jennifer P. Schneider, MD, PhD January 2006 Volume 61, Number 1 Geriatrics

Schneider speculates that increased bone density from the bisphosphonate drug does not necessarily equate with good bone quality. By decreasing osteoclast activity and bone resorption, and therefore bone formation as well, microdamage, and brittle bone may result in fractures.(11)

Odvina reports on a series of 9 patients who suffered spontanous fracture while on fosamax (alendonate). Five of the nine cases were spontaneous mid femur fractures.(12)  Two had bilateral mid femur fractures just like those sustained by Toulouse Lautrec. Six of the fractures showed delayed or absent fracture healing.  Histomorphometric analysis of the cancellous bone showed markedly suppressed bone formation, and Odvina raised the possibility that severe suppression of  bone turnover could develop during long-term fosamax (alendronate) therapy, resulting in increased susceptibility and delayed healing of fractures.

Dimitrakopoulos report on 11 patients presenting with necrosis of the jaw, claiming this to be a new complication of bisphosphonate therapy administration, i.e. osteonecrosis of jaws.(13) He advised clinicians to reconsider the merits of the rampant use of bisphosphonates. Osteonecrosis of the jaw is a common finding in pycnodysostosis. The bisphosphonates recreate the same clinical profile of spontaneous mid femur fractures, failure of bone healing and jaw necrosis which tormented Toulouse Lautrec.

In spite of these widely adverse effects of bisphosphonates, there are four more drugs in clinical trials specifically designed to inhibit cathepsin K, the enzyme defect in Lautrec's genetic bone disease.(14)  FDA approval for use in osteoporosis treatment is expected. Excuse me here, but perhaps this thinking needs re-evaluation. In essence, these drugs are creating a population of women with Toulouse Lautrec’s bone disease.


Ironically, women who sustain fractures while on Fosamax are told by their docs that the fractures are due to the underlying osteoporosis, not the drug.  For a recent example that I know of, a 60 year old female sustained a fractured elbow after minor trauma at home in the kitchen. She claims that, if not for the biphosphate drug, her fracture would have been much worse. When patients continue to fracture while on the bisphosphonate drugs, the medical system tends to blame it on the underlying osteoporosis, not the drug.  Sound familiar?

Conclusion:

The obvious conclusion is that this entire class of bisphosphonate drugs should be banned, and I predict that they will be banned within the next few years.  Remember that you read it here first. If you would like to read more about the bisphosphonate drugs, see this article, Bisphosphonates for Osteoporosis, A Closer Look at the Data by Jeffrey Dach MD. (16)

Links to Articles With Related Content:

Fosamax for Pre-Osteoporosis, A Bad Idea .

Fosamax Induced Femur Fractures by Jeffrey Dach MD
Bisphosphonates for Osteoporosis, A Closer Look at the Data by Jeffrey Dach MD
Fosamax, Actonel, Osteoporosis and Toulouse Lautrec by Jeffrey Dach M.D.
Osteoporosis web page on jeffrey dach md Web site
Jeffrey Dach MD
www.drdach.com
www.jeffreydach.com
www.naturalmedicine101.com
www.truemedmd.com

References and Links

(1) http://www.ajronline.org/cgi/reprint/182/2/319.pdf
Treatment of Chronic Symptomatic Vertebral Compression Fractures with Percutaneous Vertebroplasty,Daniel B. Brown Louis A. Gilula Manu Sehgal Joshua S. Shimony, AJR 2004;182:319–322

(2) http://www.emedicine.com/RADIO/topic871.htm
Vertebroplasty and Kyphoplasty, Percutaneous Article Last Updated: Jul 27, 2006 Jeffrey P Kochan, MD, Associate Professor of Radiology and Neurosurgery, Temple University School of Medicine; Director, Diagnostic and Interventional Neuroradiology, Department of Radiology, Temple University Hospital

(3) http://www.betterbones.com/research/articles/bjaffe.PDF
Acid-Alkaline Balance and Its Effect on Bone Health 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

(4) http://www.ncbi.nlm.nih.gov/pubmed/8950879
Lancet. 1996 Dec 7;348(9041):1535-41 Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group.Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC, Bauer DC, Genant HK, Haskell WL, Marcus R, Ott SM, Torner JC, Quandt SA, Reiss TF, Ensrud KE.

(5) http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=9529353
Am J Hum Genet. 1998 April; 62(4): 848–854.  Paternal uniparental disomy for chromosome 1 revealed by molecular analysis of a patient with pycnodysostosis.
B D Gelb, J P Willner, T M Dunn, N B Kardon, A Verloes, J Poncin, and R J Desnick
Department of Pediatrics, Mount Sinai School of Medicine, New York, NY, USA.
(6) http://www.ncbi.nlm.nih.gov/entrez/dispomim.cgi?id=265800
OMIMTM - Online Mendelian Inheritance in Man TM #265800 GeneTests, PYCNODYSOSTOSIS A number sign (#) is used with this entry because pycnodysostosis can be caused by mutation in the cathepsin K gene (CTSK; 601105).

(7) http://jcem.endojournals.org/cgi/content/full/89/4/1538
The Journal of Clinical Endocrinology & Metabolism Vol. 89, No. 4 1538-1547
CLINICAL CASE SEMINAR Decreased Bone Turnover and Deterioration of Bone Structure in Two Cases of Pycnodysostosis Nadja Fratzl-Zelman, Angelika Valenta, Paul Roschger, Alexander Nader, Bruce D. Gelb, Peter Fratzl and Klaus Klaushofer

(8) http://www.ejbjs.org/cgi/reprint/60/8/1128
J Bone Joint Surg Am Taylor et al. 60 (8): 1128. Pycnodysostosis. A case report

(9) http://lib.bioinfo.pl/pmid:16831938
Ann N Y Acad Sci. 2006 Apr ;1068 :367-401 16831938 (Bisphosphonates: from bench to bedside. R Graham G Russell The Botnar Research Centre, Nuffield Department of Orthopaedic Surgery, University of Oxford, Headington, Oxford, OX3 7LD, UK. The discovery and development of the bisphosphonates (BPs) as a major class of drugs for the treatment of bone diseases has been a fascinating journey that is still not over.

(10) http://jcem.endojournals.org/cgi/content/full/90/3/1897
The Journal of Clinical Endocrinology & Metabolism Vol. 90, No. 3 1897-1899
Long-Term Safety of Bisphosphonates, Susan M. Ott, University of Washington Seattle, Washington 98195

(11) http://geriatrics.modernmedicine.com/geriatrics/data/articlestandard/geriatrics/022006/283268/article.pdf
Case Report Jennifer P. Schneider, MD, PhD Should bisphosphonates be continued indefinitely?
January 2006 Volume 61, Number 1 Geriatrics

(12) 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

(13) http://www.ncbi.nlm.nih.gov/pubmed/16687238?dopt=AbstractPlus
Int J Oral Maxillofac Surg. 2006 Jul;35(7):588-93. Epub 2006 May 9.
Bisphosphonate-induced avascular osteonecrosis of the jaws: a clinical report of 11 cases.
Dimitrakopoulos I, Magopoulos C, Karakasis D.
Department of Oral and Maxillofacial Surgery, Aristotle University of Thessaloniki, Greece.

(14) http://www.nature.com/nrd/journal/v5/n9/full/nrd2092.html
Reviews Nature Reviews Drug Discovery 5, 785-799 (September 2006) Targeting proteases: successes, failures and future prospects Boris Turk Cathepsin K and osteoporosis. Cathepsin K is a lysosomal cysteine cathepsin predominantly located in osteoclasts and is the major enzyme involved in bone resorption. The first evidence for this role came from a genetic study on pycnodysostosis, a rare genetic disorder associated with severe defects in bone growth, which revealed that an inactivating mutation in the gene encoding cathepsin K is a causative factor.

(15) http://www.perque.com/
Russell Jaffe MD Perque Supplements

(16)
http://jeffreydach.com/2008/03/09/bisphosphonates-for-osteoporosis-a-closer-look-at-the-data-by-jeffrey-dach-md.aspx
Bisphosphonates for Osteoporosis, A Closer Look at the Data by Jeffrey Dach MD

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