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OSTEONECROSIS OF THE JAWS IN MYELOMA:
Time Dependent Correlation with AREDIA and ZOMETA Use
By Brian G.M. Durie, MD
12.07.04



Please note that the the material below is intended primarily for healthcare professionals and researchers. Patient-oriented material is available by clicking this link.

At the 2004 Annual Meeting of the American Society of Hematology, Dr. Durie presented the results of the web-based survey that many of you were kind enough to help us with. We are encouraged by the discussions that have ensued and are hopeful that this will help us raise awareness about this very serious issue and facilitate timely action.

View a slide show of Dr. Durie's ASH 2004 Presentation.

PDFs and videos of this presentation can be viewed by clicking on the icons on the right.


Dr. Robert A. Kyle, chairman of the IMF's Scientific Advisory Board, made the following statement following Dr. Durie's presenation at ASH:

"The presentation by Dr. Durie raises a concern to all of us.

Although the web-based study has epidemiologic shortcomings and does not allow one to say anything about the frequency of osteonecrosis of the jaw, it does demonstrate its existence. In my 40+ years of caring for patients with multiple myeloma, I have not seen or heard of osteonecrosis of the jaw in this disease until 1-2 years ago.

We definitely need more data/information about this condition. At present I believe it is prudent to advise patients to avoid dental procedures while taking intravenous bisphosphonates. Studies are needed to define the duration and dosage of bisphosphonate therapy for multiple myeloma. Furthermore, we need to address the status/activity of myeloma bone disease in making this decision.

Bisphosphonates have proven benefit in multiple myeloma. We must be careful not to “throw out the baby with the bath water.”


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Salvatore L. Ruggiero, DMD, MD Talks About Osteonecrosis of the Jaw (ONJ)
AAOMS Position Paper on Bisphosphonate-Related Osteonecrosis of the Jaws
American Society for Bone and Mineral Research (ASBMR) Issues report on ONJ risk
Bisphosphonate-associated osteonecrosis of mandibular and maxillary bone.
FDA Oncologic Drugs Advisory Committee Meeting On Aredia And Zometa
Journal of the National Cancer Institute
Mayo Clinic Consensus Statement for the Use of Bisphosphonates in Multiple Myeloma
NEJM Publishes Correspondence On ONJ
OSTEONECROSIS OF THE JAWS IN MYELOMA:
Time Dependent Correlation with AREDIA and ZOMETA Use
Osteonecrosis Web Survey Results Presented At 2004 ASH Meeting
Special Advisory: Osteonecrosis of the Jaw
Use of Bisphosphonates in Multiple Myeloma: IMWG Response to Mayo Clinic Consensus Statement
Wall Street Journal Article On Osteonecrosis Of The Jaws
Aredia/Zometa and osteonecrosis of the jaws
Food and Drug Administration (FDA) MedWatch Postings About Osteonecrosis Of The Jaw


You might also be interested in:

Salvatore L. Ruggiero, DMD, MD Talks About Osteonecrosis of the Jaw (ONJ)

AAOMS Position Paper on Bisphosphonate-Related Osteonecrosis of the Jaws
Bisphosphonate-related osteonecrosis of the jaw (BRON) adversely affects the quality of life and produces significant morbidity in afflicted patients. Oral and maxillofacial surgeons have been responsible for counseling, managing, and treating a majority of these patients. The strategies set forth in this position paper were developed by a Task Force appointed by the American Association of Oral and Maxillofacial Surgeons (AAOMS).

American Society for Bone and Mineral Research (ASBMR) Issues report on ONJ risk
The American Society for Bone and Mineral Research (ASBMR) announced today the publication of a report that examines the link between a class of widely prescribed drugs used to strengthen bones and the disorder known as Osteonecrosis of the Jaw (ONJ). The report, authored by an international, multidisciplinary task force, was convened by the ASBMR to look at the possible association between ONJ, a deterioration of the jawbone, and a class of drugs known as bisphosphonates, which in recent years have been linked to the condition.

Bisphosphonate-associated osteonecrosis of mandibular and maxillary bone.
An article from Cancer, in which researchers from the College of Dental Medicine, Nova Southeastern University in Fort Lauderdale, Florida present results of a study of 17 patients with cancer with bone metastases and 1 patient with osteopenia who received treatment with bisphosphonates and who subsequently developed osteonecrosis of the mandible and/or maxilla.

FDA Oncologic Drugs Advisory Committee Meeting On Aredia And Zometa
The committee discussed safety concerns, specifically osteonecrosis of the jaw (ONJ), associated with two bisphosphonates, NDA 21-223, ZOMETA® (zoledronic acid) Injection and AREDIA®, NDA 20-036 (pamidronate disodium for injection), both from Novartis Pharmaceuticals Corp.

Journal of the National Cancer Institute
Intravenous Bisphosphonate Therapy andInflammatory Conditions or Surgery of the Jaw: A Population-Based Analysis

Mayo Clinic Consensus Statement for the Use of Bisphosphonates in Multiple Myeloma
A multidisciplinary panel consisting of hematologists, dental specialists, and nurses specializing in the treatment of myeloma reviewed available data concerning the use of bisphosphonates. Guidelines for the use of bisphosphonates in MM were developed. This link is to the full article.

NEJM Publishes Correspondence On ONJ
The New England Journal of Medicine published correspondence from Drs. Durie, Richardson, Duck and Tarassoff on Osteonecrosis of the Jaw in its July 7, 2005 issue (N Engl J Med. 2005 Jul 7;353(1):99-102; discussion 99-102.)

OSTEONECROSIS OF THE JAWS IN MYELOMA:
Time Dependent Correlation with AREDIA and ZOMETA Use
At the 2004 Annual Meeting of the American Society of Hematology, Dr. Durie presented the results of the web-based survey that many of you were kind enough to help us with. We are encouraged by the discussions that have ensued and are hopeful that this will help us raise awareness about this very serious issue and facilitate timely action.

Osteonecrosis Web Survey Results Presented At 2004 ASH Meeting

Special Advisory: Osteonecrosis of the Jaw

Use of Bisphosphonates in Multiple Myeloma: IMWG Response to Mayo Clinic Consensus Statement
Published in the Mayo Clinic Proceedings 2007;82:516-522

Wall Street Journal Article On Osteonecrosis Of The Jaws
You can also read a Wall Street Journal article that discusses this issue and includes a quote from Dr. Durie

Aredia/Zometa and osteonecrosis of the jaws

Food and Drug Administration (FDA) MedWatch Postings About Osteonecrosis Of The Jaw
FDA and Novartis notified healthcare professionals of revisions the PRECAUTIONS and ADVERSE REACTIONS sections of labeling for Aredia and Zometa