FDA Says Osteoporosis Drugs Cause Femur Fractures
by Jeffrey Dach MD
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 (Oct
13, 2010) warning of “possible” risk of femur fractures caused by the
osteoporosis drugs such as fosamax, boniva, and actonel, etc. They also
added a new warning label which was recommended by a Task Force assigned
to look into this issue. The Task Force found that almost all women
suffering from atypical fractures of the mid femur were on these drugs. Left image: femur fracture while on alendronate courtesy of NEJM.
(The task force consists of experts of the American Society of Bone and Mineral Research).
This same ASBMR task force previously reported (2007)
these same drugs cause osteonecrosis of the jaw. 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 they do. This is a very bad thing, and indicates a very profound
problem with the drug.
image : Cortical Thickening, and obvious Tranverse Mid Femur Fracture
in a patient on osteoporosis drugs- Bisphosphonate. Image courtesy of
Dr Jörg Schilcher and Per Aspenberg, Acta Orthop . 2009 August 7; 80(4): 413–415. Incidence of stress fractures of the femoral shaft in women treated with bisphosphonates.
Dr Susan Ott Reports
At a recent medical meeting, the ASBMR in Toronto, Susan Ott MD presented data on atypical femur fractures induced
by fosamax. She reviewed Xrays 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 were on bisphosphonates (96.4%) like
fosamax. Dr. Ott reported these atypical fractures have a
characteristic X-ray appearance, and may be bilateral. The
fracture is through the mid-shaft, and the outer bony margin hickened
(suggesting a stress fracture). These fractures are spontaneous,
with no trauma. 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 Bisphosphonates
for 12 years.
According to a 2009 Swedish study by Aspberger, the incidence of mid femur stress fracture is 50 times higher for patients on Bisphosphonates compared to untreated women (0.1% vs 0.002 %).
Osteoporosis Drug Use Associated With Stress Fractures of Mid-Femur
Dr Isaacs from Australia reported in a study August 2010 that
these drugs cause insufficiency or stress fractures of the femur. He
reviewed X-rays and studied 100 consecutive patients with spontaneous
femur fracture before and after availability of bisphosphonate drugs.
He found Xray evidence of pre-existing stress fractures in all 41 cases
on bisphosphonates. However, before the bisphosphonate era, there were
no pre-existing stress fractures in ANY of these 21 earlier cases.
Dr Isaacs study suggests that bisphosphonate drugs damages and
weakens the bone, making it susceptible to painful stress fracture.
The stress fracture may then cause a spontaneous mid femur fracture.
Left image: Arrow shows location of thickened cortex indicating stress fracture. Image courtesy of Aspenberg et al Acta
Orthop. 2010 August; 81(4): 460–462. Histology of an undisplaced
femoral fatigue fracture in association with bisphosphonate treatment.
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 it on
the osteoporosis, and not an adverse effect of the 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”.
This article is part one, for part two CLICK HERE.
Articles with Related Content :
Fosamax and Fractured Femurs
Fosamax, a Bad Drug in Litigation
Fosamax, Actonel, Osteoporosis and Toulouse Lautrec by Jeffrey Dach MD
Links and References
1) Epidemiology, radiology and histology of atypical femoral fractures by Jörg Schilcher
FDA NEWS RELEASE For Immediate 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
The U.S. Food and Drug Administration today warned patients and health
care providers about the possible risk of atypical thigh bone (femoral)
fracture in patients who take bisphosphonates, a class of drugs used to
prevent and treat osteoporosis. A labeling change and Medication Guide
will reflect this risk.
OCTOBER 13, 2010, 1:06 P.M. ET.PRESS RELEASE:
FDA Warns On Risk Of Thigh Bone Fractures With Bisphosphonates Drugs
FDA: Possible increased risk of thigh bone fracture with bisphosphonates
Labeling change adds warning about possible risks of long-term use of
osteoporosis drugs The U.S. Food and Drug Administration today warned
patients and health care providers about the possible risk of atypical
thigh bone (femoral) fracture in patients who take bisphosphonates, a
class of drugs used to prevent and treat osteoporosis. A labeling change
and Medication Guide will reflect this risk.
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, released today,
providing important perspectives on the potential association between
long term treatment with the class of osteoporosis drugs known as
bisphosphonates and a rare but serious type of fracture of the thigh
bone (femur). The report includes a case definition that describes the
atypical features of these unusual femur fractures. FDA believes this
case definition will help greatly in identifying cases and reporting on
them, and should facilitate future studies comparing the frequency of
these unusual fractures both in patients treated with bisphosphonates
and those who have not received bisphosphonates.
The ASBMR Task Force’s recommendations include recommended changes to
product labels alerting healthcare professionals and patients to the
possibility of unusual femur fractures with long-term use of
bisphosphonates. FDA has assembled and is thoroughly reviewing all long
term data available on the products, as well as all safety reports, and
is considering label revisions. FDA will keep the public informed of
additional findings and actions on this issue.
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, Burr D, Ebeling PR, Abrahamsen B, Adler RA, Brown TD, Cheung AM,
Cosman F, Curtis JR, Dell R, Dempster D, Einhorn TA, Genant HK, Geusens
P, Klaushofer K, Koval K, Lane JM, McKiernan F, McKinney R, Ng A, Nieves
J, O’Keefe R, Papapoulos S, Sen HT, van der Meulen MC, Weinstein RS,
Whyte M; American Society for Bone and Mineral Research.
Columbia University, College of Physicians and Surgeons, PH 8 West 864, 630 West 168th Street, New York, NY 10032, USA.
Reports linking long-term use of bisphosphonates (BPs) with atypical
fractures of the femur led the leadership of the American Society for
Bone and Mineral Research (ASBMR) to appoint a task force. Moreover, a
causal association between BPs and atypical fractures has not been
established. However, recent observations suggest that the risk rises
with increasing duration of exposure, and there is concern that lack of
awareness and underreporting may mask the true incidence of the
problem.the task force recommends that an international registry be
established a change in labeling of BPs. Research directions should
include animal models, increased surveillance, and additional clinical
JBMR Publishes ASBMR Task Force Report on Atypical Femoral Fractures
Date: 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
FDA warns of femoral fracture risk with bisphosphonates
Long-term use of osteoporosis drugs may increase risk of thigh bone
fracture; warning added to drug labeling. Last week, FDA warned
patients and health care providers about the possibility of an increased
risk of thigh bone fracture in patients taking bisphosphonates, drugs
used in the prevention and treatment of osteoporosis. This warning will
be added to the drugs’ labels and Medication Guides. FDA reported that
atypical femur fractures, a rare but serious type of thigh bone
fracture, have been predominantly reported in patients taking
bisphosphonates. While the agency said it is not clear whether the drugs
are the cause, there is some evidence that the fractures are related to
use of bisphosphonates for more than 5 years. The optimal duration of
bisphosphonate use in patients with osteoporosis is unknown.
The labeling and Medication Guide changes will apply only to
bisphosphonates approved for osteoporosis, which include the oral
bisphosphonates Fosamax (alendronate—Merck), Fosamax Plus D
(alendronate/cholecalciferol—Merck), Actonel (risedronate—Procter &
Gamble), Actonel with Calcium (risedronate/calcium carbonate—Procter
& Gamble), Boniva (ibandronate—Roche), Atelvia (risedronate—Warner
Chilcott), and their generic equivalents, as well as injectable
bisphosphonates Reclast (zoledronic acid—Novartis) and Boniva. The
changes will not apply to drugs in this class used for Paget disease or
cancer and hypercalcemia; these include Didronel (etidronate—Procter
& Gamble), Zometa (zoledronic acid—Novartis), Skelid
(tiludronate—sanofi aventis), and their generic equivalents.
FDA recommended that health professionals be aware of this possible
risk in patients using bisphosphonates and encouraged periodic
reevaluation of the need for therapy with this drug lasting more than 5
years. Patients taking bisphosphonates for osteoporosis should not stop
taking the medication unless told to do so by a health professionals.
Patients should report any new thigh or groin pain the their health care
provider; providers should evaluate these patients for possible femur
fracture. Patients and health professionals should report adverse
effects associated with the use of bisphosphonates to FDA’s MedWatch.
FDA Warns Docs, Patients of Femoral Fracture Risk Linked to Some Bisphosphonates
Long-term Use Suggests Need for Periodic Bone Density Reassessment
By News Staff 10/18/2010 The FDA announced in March that it was
conducting a safety review of oral bisphosphonates. That review included
data from a report recently published in the Journal of Bone and
Mineral Research that reviewed more than 300 cases of atypical femoral
fractures. More than 90 percent of those patients had taken
bisphosphonates for five years or more, and 25 percent of the patients
had fractures in both legs.
Bisphosphonates labeling updated to include atypical fractures warning
October 13, 2010 The labeling for bisphosphonates will be updated to
include information in the Warnings and Precautions section about the
risk of atypical fractures of the thigh (ie, subtrochanteric and
diaphyseal femur fractures) in patients who take bisphosphonates for
osteoporosis. Although it is not clear if bisphosphonates are the cause,
these unusual femur fractures have been predominantly reported in
patients taking bisphosphonates and may be related to long-term term
bisphosphonate use. The FDA will require a new Limitations of Use
statement in the Indications and Usage section of the labels for these
drugs. This statement will describe the uncertainty of the optimal
duration of use of bisphosphonates for the treatment and/or prevention
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, Burr D, Cauley J, Dempster DW, Ebeling PR, Felsenberg D, Gagel
RF, Gilsanz V, Guise T, Koka S, McCauley LK, McGowan J, McKee MD, Mohla
S, Pendrys DG, Raisz LG, Ruggiero SL, Shafer DM, Shum L, Silverman SL,
Van Poznak CH, Watts N, Woo SB, Shane E; American Society for Bone and
ASBMR TORONTO 2010 Susan Ott MD
a> /> /> /> /> /> ASBMR: Analysis Adds to Evidence of
By Michael Smith , North American Correspondent, MedPage Today
Published: October 20, 2010 Reviewed by Zalman S. Agus, MD; Emeritus
Professor University of Pennsylvania School of Medicine and Dorothy
Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
TORONTO — A large study presented here has added more evidence
linking the use of bisphosphonate drugs used to treat osteoporosis to an
elevated risk of what are being called “atypical” femur fractures. In
an analysis of data collected by the large California health maintenance
organization Kaiser Permanente, the vast majority of people with such
atypical fractures were taking a bisphosphonate drug, according to Susan
Ott, MD, of the University of Washington. In fact, over a three-year
period, the HMO’s doctors recorded 135 atypical fractures — out of
nearly 16,000 broken femurs — and all but 3.7% of the patients involved
were taking a bisphosphonate, Ott reported at the annual meeting of the
American Society for Bone and Mineral Research.In addition, she noted
that the rate of atypical fractures appeared to rise with longer
duration of bisphosphonate use.
The atypical fractures are characterized by a transverse break in the
diaphyseal region of the femur, with lateral cortical thickening and
flaring of the lateral cortex, associated with low or no trauma. There
is often prodromal pain in the thigh or groin and the fracture can be
The FDA ordered labeling changes for bisphosphonate drugs to warn
about the risk of atypical fractures after an ASBMR task force found 310
cases — in which 94% of patients were taking bisphosphonates.
For the current analysis, Ott and colleagues had access to medical
reports — including x-rays — of the 15,819 femur fractures that Kaiser
covered in 2007, 2008, and 2009.
Among the 135 fractures they found:
•98% of patients were women, with an average age of 71 and an average body mass index of 26.6.
•53% had previous fragility fractures, but only 2% died in the year following the atypical fracture.
•On average, the patients had been talking bisphosphonates for 6.3 years.
•67% had prodromal pain and 25.9% had bilateral fractures.
•60% of the breaks were on the shaft and 40% were subtrochanteric.
The proportion of patients with such fractures rose steadily with the
duration of use, Ott said, rising from about two per 100,000 if
bisphosphonates were used for less than a year to almost 250 per 100,000
after 12 years of use.
Clin Orthop Relat Res. 2010 Aug 31. [Epub ahead of print] 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,
BACKGROUND: Emerging evidence has linked the long-term use of bisphosphonates with femoral insufficiency fractures.
It has been suggested that the prolonged effect on bone remodeling
leads to the accumulation of microfractures and weakening of bone.
We investigated the association between bisphosphonate use and femoral insufficiency fractures.
METHODS: We evaluated 100 patients with low-energy femoral shaft
fractures before and after bisphosphonates became available for use.
Twenty-one consecutive patients who presented between January 1995 and
February 1997 were compared with 79 consecutive patients who presented
between January 2007 and February 2009. The radiographs of all 100
patients were examined for evidence of preexisting insufficiency
fractures. We identified insufficiency fractures by a transverse
fracture line on the tension side of the femur with lateral cortical
thickening immediately adjacent to the fracture. Relevant details from the history were recorded.
RESULTS: Forty-one patients had an underlying femoral insufficiency fracture, all of whom had been receiving bisphosphonate therapy.
Among the 21 patients with low-energy femoral fractures before the
availability of bisphosphonates, none had insufficiency fractures. Of
the 41 patients with insufficiency fractures, 29 (71%) had prodromal
pain and 18 (44%) had bilateral insufficiency fractures. Bisphosphonate
use was associated (odds ratio greater than 1000) with insufficiency
fracture. The mean duration of bisphosphonate use in patients with
insufficiency fractures was longer than in patients without fractures
(7.1 versus 3.2 years).
CONCLUSION: Long-term bisphosphonate use is associated with
insufficiency fractures of the femoral shaft, which commonly present
with prodromal thigh pain and may be bilateral. These fractures were not
seen before bisphosphonates became available for use.
Curr Osteoporos Rep. 2010 Mar;8(1):34-9. Atypical subtrochanteric and
femoral shaft fractures and possible association with
bisphosphonates.Nieves JW, Cosman F. Clinical Research Center, Helen
Hayes Hospital, Route 9W, West Haverstraw, NY 10993, USA.
Several case series and multiple individual case reports suggest that
some subtrochanteric and femoral shaft fractures might occur in patients
who have been treated with long-term bisphosphonates. Several unique
clinical and radiographic features are emerging: prodromal thigh pain
prior to the fracture, complete absence of trauma precipitating the
fracture, and bilateral fractures in some patients. Radiographic
features include presence of stress reaction, transverse or short
oblique fractures, and thick femoral cortices. The overall incidence of
subtrochanteric and shaft fractures combined is below 30 per 100,000
person-years, so this type of fracture is much less common than proximal
femur (hip) fracture. Furthermore, the unique “atypical” fracture type
is a subset of all subtrochanteric and femoral shaft fractures. The
putative mechanism is unknown, and more research is needed to identify
distinctive characteristics and the pathophysiology of these atypical
fractures. There is no rationale to withhold bisphosphonate therapy from
patients with osteoporosis, although continued use of bisphosphonate
therapy beyond a treatment period of 3 to 5 years should be re-evaluated
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.
Department of Orthopedics, Phranakhon Si Ayutthaya Hospital, Phranakhon Si Ayutthaya, Thailand.
JAMA. 2010;304(13):1480-1484 (doi:10.1001/jama.2010.1360)
Atypical Fractures as a Potential Complication of Long-term Bisphosphonate Therapy
Deborah E. Sellmeyer
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,
Department of Radiology, New York University Hospital for Joint Diseases, New York, NY 10009, USA.
OBJECTIVE: A paradoxical association between long-term alendronate
therapy and low-energy subtrochanteric femoral fractures has been
recently recognized. A retrospective review of 34 such femoral fractures
CONCLUSION: Subtrochanteric femoral fractures associated with long-term
alendronate therapy present with minimal trauma, may be chronic, and
when incomplete may be missed. The characteristic imaging features
include initial involvement and focal thickening of the lateral cortex,
transverse orientation, medial beak, and superior displacement and varus
angulation at the fracture site.
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.
Bisphosphonates are the most common medication used to treat patients
with documented osteoporosis. Recently, reports have associated
long-term bisphosphonate use with low-energy femur fractures. While no
definitive mechanism has been associated, bisphosphonate use has been
strongly implicated. This article presents the case of a 65-year-old
woman with a 2-year history of ibandronate use presenting with
simultaneous low-energy femoral shaft fractures. The patient reported
prodromal bilateral thigh pain and was seen by a spine surgeon.A review
of the literature implicates long-term ibandronate use in low-energy
femur fractures. With most of the basic science studies demonstrating
suppressed bone turnover after 5 years of treatment with alendronate,
the significance of the present case also lies in the relatively short
duration of time the patient was on ibandronate before suffering the
bilateral femoral shaft fractures. Possible pathophysiology for the
fractures includes suppressed bone turnover that may allow microcracks
to propagate in cortical bone, which can weaken the bone and possibly
predispose it to fractures. Patients who have been on bisphosphonates
long term should be questioned about thigh pain and have radiographs of
their femurs obtained if pain exists. Furthermore, if a patient presents
with a single subtrochanteric or diaphyseal low-energy femur fracture
after long-term bisphosphonate use, a radiograph of the contralateral
femur should be obtained to assess for a cortical stress reaction.
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, Shen L, Das De S. University Orthopaedic, Hand and Reconstructive Microsurgery Cluster, Singapore.
There have been recent reports linking alendronate and a specific
pattern of subtrochanteric insufficiency fracture. We performed a
retrospective review of all subtrochanteric fractures admitted to our
institution between 2001 and 2007. There were 20 patients who met the
inclusion criteria, 12 of whom were on long-term alendronate.
Alendronate-associated fractures tend to be bilateral (Fisher’s exact
test, p = 0.018), have unique radiological features (p < 0.0005), be
associated radiologically with a pre-existing ellipsoid thickening of
the lateral femoral cortex and are likely to be preceded by prodromal
pain. Biomechanical investigations did not suggest overt metabolic bone
disease. Only one patient on alendronate had osteoporosis prior to the
start of therapy. We used these findings to develop a management
protocol to optimise fracture healing. We also advocate careful
surveillance in individuals at-risk, and present our experience with
screening and prophylactic fixation in selected patients.
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
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.
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,
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.
Low-energy fractures of the femoral shaft with a simple, transverse
pattern and hypertrophy of the diaphyseal cortex are associated with
alendronate use. This may result from propagation of a stress fracture
whose repair is retarded by diminished osteoclast activity and impaired
microdamage repair resulting from its prolonged use.
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,
In 2007, the overall population of women older than 55 years in the
area of interest was 91,956. Of these, 3,087 (3.4%) were on continous
treatment with bisphosphonate drugs. In order to combine the catchment
areas of östergötland county and Lund University Hospital and the
different time intervals for evaluation, we calculated the annual
incidence of femoral shaft stress fractures to be 2.4 fractures per
year, 1.5 of which were associated with bisphosphonate treatment. The
overall incidence of stress fractures in patients on continuous
bisphosphonate treatment (weighted for the different catchment areas)
was 1/1,000 per year (95% CI: 0.3–2) as compared to 0.02/1,000 (95% CI:
0.004–0.1) for the untreated women.
As a rough estimate, we therefore calculated the relative risk without age correction, and found a 46-times increased risk of stress fracture with bisphosphonates
Injury. 2008 Feb;39(2):224-31. Epub 2008 Jan 28.
An emerging pattern of subtrochanteric stress fractures: a long-term
complication of alendronate therapy? Kwek EB, Goh SK, Koh JS, Png MA,
Department of Orthopaedic Surgery, Singapore General Hospital, Outram Road, Singapore 169608,
BACKGROUND: Subtrochanteric insufficiency fractures in
post-menopausal patients have not been commonly reported in the
literature. A recent increase in the incidence of such fractures
occurring in patients while on alendronate therapy led us to conduct a
retrospective review of these patients in our institution.
METHODS: Seventeen patients, with a mean age of 66 years, sustained
low energy subtrochanteric fractures within a 20-month period. These
patients were incidentally found to be on alendronate therapy for an
average of 4.8 years. Clinical data and history were reviewed and
roentgenograms were evaluated by a single investigator. All additional
imaging and bone mineral density measurements available were analysed.
RESULTS: A characteristic fracture configuration suggestive of an
insufficiency stress fracture was identified on plain radiographs. This
consisted of (a) cortical thickening in the lateral side of the
subtrochanteric region, (b) a transverse fracture, and (c) a medial
cortical spike. In addition, 9 (53%) patients had bilateral findings of
stress reactions or fractures, and 13 (76%) had symptoms of prodromal
CONCLUSIONS: These insufficiency fractures could possibly have
developed from the over suppression of bone turnover from prolonged
alendronate therapy, in keeping with recently published evidence. This
study further highlights the need for heightened awareness of
alendronate’s potential adverse effects.
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
Jeffrey Dach MD
7450 Griffin Road
Davie, Fl 33021
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