 Overview
Reports of bisphosphonate-associated osteonecrosis of the jaw (BON)
associated with the use of Zometa (zolendronic acid) and Aredia
(pamidronate) began to surface in 2003. The majority of reported
cases have been associated with dental procedures such as tooth
extraction; however, less commonly BON appears to occur spontaneously
in patients taking these drugs1. Zolendronic acid and pamidronate
are intravenous (i.v.) bisphosphonates used to reduce bone pain,
hypercalcemia and skeletal complications in patients with multiple
myeloma, breast, lung and other cancers and Paget’s disease
of bone.
Several cases of BON have also been associated
with the use of the oral bisphosphonates,
Fosamax (alendronate), Actonel (risedronate)
and Boniva (ibandronate), for the treatment
of osteoporosis; however, it is not clear if these patients had
other conditions that would put them at risk for developing BON.2
The table below lists all oral and
i.v. bisphosphonates currently
on the market in the U.S.
| Orally
Administered Bisphosphonates |
| Brand
Name |
Manufacturer |
Generic
Name |
| Actonel |
Procter & Gamble
Pharmaceuticals |
risedronate |
| Boniva |
Roche Laboratories |
ibandronate |
| Fosamax |
Merck & Co. |
alendronate |
| Fosamax
Plus D |
Merck & Co. |
alendronate |
| Skelid |
Sanofi Pharmaceuticals |
tiludronate |
| Didronel |
Procter & Gamble
Pharmaceuticals
|
etidronate |
| Intravenously
Administered Bisphosphonates |
| Brand
Name |
Manufacturer |
Generic
Name |
| Aredia |
Novartis |
pamidronate |
| Zometa |
Novartis |
zolendronic acid |
| Bonefos |
Schering AG
|
clodronate |
Clinical Presentation
The typical clinical presentation
of BON includes pain, soft-tissue swelling and infection, loosening
of teeth, drainage, and exposed bone3.
These symptoms may occur spontaneously, or more commonly, at the
site of previous tooth extraction. Patients may also present with
feelings of numbness, heaviness and dysesthesias of the jaw. However,
BON may remain asymptomatic for weeks or months, and may only become
evident after finding exposed bone in the jaw.
Dental Management
It is important to understand that, based
on the information currently available,
the risk for developing BON is much
higher for cancer patients on i.v. bisphosphonate therapy than
the risk for patients on oral bisphosphonate therapy. Therefore,
there are different recommendations for dental management of these
patients.
For patients on oral bisphosphonate therapy
The risk of developing BON in patients
on oral bisphosphonate therapy appears
to be very low;4 however,
though the risk is small, currently
millions of patients take these drugs.
Therefore, recommendations for dental
management of patients on oral bisphosphonate
therapy | PDF
file/125k  were
developed by an expert panel assembled
by the ADA’s Council on Scientific Affairs.5 These
panel recommendations focus on conservative
surgical procedures, proper sterile
technique, appropriate use of oral
disinfectants and the principles of
effective antibiotic therapy. There
is currently no data from clinical
trials evaluating dental management
of patients on oral bisphosphonate
therapy, and therefore, these recommendations
are based on expert opinion only. A
comprehensive oral evaluation is recommended
for all patients about to begin therapy
with oral bisphosphonates (or as soon as possible after beginning
therapy).These recommendations do not address treatment of
patients on i.v. bisphosphonate therapy or patients with BON.
Refer to the information below regarding their treatment.
For patients on i.v. bisphosphonate therapy
It is important for dentists to be aware
that while on treatment, invasive dental procedures should
be avoided in patients receiving i.v. bisphosphonates, if possible.
Dentists need to exercise their professional judgment, perhaps
after consultation with the patient’s physician, in deciding
whether invasive treatment is needed
under the particular clinical situations.
The prescribing information for these drugs
recommends that cancer patients:
- Receive a dental examination prior to initiating therapy with
intravenous bisphosphonates
(Aredia and Zometa); and
- Avoid invasive dental procedures while receiving
bisphosphonate treatment. For
patients who develop osteonecrosis of the jaw while
on bisphosphonate therapy, dental
surgery may exacerbate the condition. Clinical judgment by
the treating physician should guide the management plan of
each patient based on an individual benefit/risk assessment.
Among tools useful to the dentist is a patient’s medical history, including medications. Dentists
should be aware that patients may not relay information about receiving
i.v. bisphosphonates, because these drugs are administered in oncology
wards. Therefore, patients with a history of multiple myeloma,
metastatic cancer, Paget’s disease and osteoporosis
may need to be questioned about receiving i.v. bisphosphonates.
In addition, it may be important to know of any history
of i.v. bisphosphonate administration, because these
drugs have a long half-life (years).6
An expert panel
convened by Novartis Pharmaceuticals
Corporation (the manufacturer of Zometa
and Aredia) in 2004, made the following
recommendations for prevention, diagnosis and treatment
of osteonecrosis of the jaw in patients
on i.v. bisphosphonate therapy:3,7
- Patients should be educated on maintaining excellent
oral hygiene to reduce the risk of infection.
- Dentists should check
and adjust removable dentures
to avoid soft-tissue injury.
- Routine dental cleanings
should be performed with care
not to inflict any soft-tissue injury.
- Dental
infections should be managed
aggressively and nonsurgically (when possible).
- Endodontic
therapy is preferable to
extractions; and, when necessary, coronal amputation
with root canal therapy on retained
roots to avoid the need for extraction.
For patients with BON
Recommendations for the treatment
of patients with BON have been
published7 and are posted on
the Web site for the Journal
of Oncology Practice .
Obtaining Informed Consent
- Obtaining Informed Consent Relating
to Risks Associated with Oral Bisphosphonate
Use | PDF
file/27k
This document is designed to provide general
information to patients and to guide dentists
in fully and clearly explaining risks, benefits and treatment alternatives
to patients. However, this document contains only a general discussion
of issues surrounding treating patients taking oral bisphosphonates.
It does not contain the specific information likely required to
be in an informed consent form. The requirements for informed consent
forms may vary from one jurisdiction to another. Dentists should
consult with an attorney to develop a form which will be effective
in a particular state.
Endnotes
- Woo
S-B, Hande K, Richardson PG.
Osteonecrosis of the jaw and
bisphosphonates. N Engl J Med
2005;353:100 .
- Ruggiero
SL, Mehrotra B, Rosenberg TJ,
Engroff SL. Osteonecrosis of
the jaws associated with the
use of bisphosphonates: A review
of 63 cases. J Oral Maxillofac
Surg 2004;62:527-34 .
- Expert Panel Recommendations for
the Prevention, Diagnosis, and Treatment
of Osteonecrosis of the Jaws: June
2004 | PDF
file/56k .
- Migliorati
CA, Casiglia J, Epstein J, Jacobsen
PL, Siegel MA, Woo S-B. Managing
the care of patients with bisphosphonate-associated
osteonecrosis: An American Academy
of Oral Medicine position paper.
JADA 2005;136:1658-68 .
- ADA Council on Scientific Affairs.
Expert Panel Recommendations: Dental
Management of Patients on Oral Bisphosphonate
Therapy. June 2006 .
| PDF
file/125k
- Ott SM. Long-term safety of bisphosphonates.
J Clin Endocrinol Metab 2005;90:1897-9.
-
Ruggiero S, Gralow J, Marx RE,
Hoff AO, Schubert MM, Huryn JM,
Toth B, Damato K, Valero V. Practical Guidelines
for the Prevention, Diagnosis, and Treatment
of Osteonecrosis of the Jaw in Patients
With Cancer. J Oncol Prac 2006;2:7-14 .
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