Fosamax and Dead Jaw Syndrome sure makes Vitamin K-2 look good.
Jacob Schor, ND
July 10, 2006
Subject: Drugs used to treat osteoporosis have been linked to development of a condition called avascular necrosis of the jaw. Vitamin K-2 supplementation as an alternative treatment for osteoporosis is looking better and better.
I hate to discover that I've wrong about something and given people inaccurate information; case in point are Bisphosphonate drugs. Over the years I've told patients that Fosamax, for example, is an ok drug and does pretty much what it is supposed to. That is, it increases bone density and decreases fracture rates. Of course it was once a bit tricky to take, frequently causing reflux problems, but the newer formulations have proven more tolerable.
I've been wrong. Fosamax isn't as innocuous as I thought. Fosamax and other similar drugs can cause avascular necrosis of the jaw, a condition that has been nicknamed ‘Dead Jaw' by hungry malpractice attorneys. This is a particularly nasty thing to happen. Trust me, you don't want it. This isn't a recent discovery; a paper published three years ago warned of a ‘growing epidemic' of avascular necrosis linked to the drugs prescribed for osteoporosis. [i]
By July of 2004 the paper titles use the words “bisphosphonates” and “caution” together. [ii]
In February, 2005 Australians wrote of ten separate cancer patients receiving high dose bisphosphonates who developed ‘dead jaw.' [iii] Another paper in July of 2005 also associated dead jaw with bisphosphonate use. [iv] Once the association was known, researchers actively looked for cases. The Israelis combed through their records and reported 10 more cases in August, 2005. [v] These were the first cases reported of non-cancer patients developing dead jaw. In addition to taking a bisphosphonate medication for osteoporosis, all of the patients had had recent dental work just prior to the onset of necrosis.
In July of 2005, Marx et al, writing in the Journal of Oral and Maxillofacial surgery reviewed 119 cases of bisphosphonate related necrosis [vi] Around this point the articles start coming so close together I give up trying to read all of them. A current Google. scholar search on the combined terms of avascular necrosis and jaw and bisphosphonates yields links to 123 papers.
In most of the reported cases the patients were receiving the intense IV forms of the drug that are used during cancer treatment. Yet oral drugs like Fosamax are not entirely safe. One recent story reported that about 10% of those with ‘dead jaw' were osteoporosis patients who had taken an oral bisphosphonate, mainly Fosamax. There are still many unanswered questions
The longer the drug is used the more likely the reaction will be triggered. It isn't the drug alone that is the problem. Some form of dental surgery, typically tooth extraction, also precedes the development. We don't know how common a reaction this is. What we do know is that the stronger the drug, the longer it is taken and the more intense the dental work, the higher the odds are of triggering this dead jaw syndrome.
Although using bisphosphonates in treating some forms of cancer especially in metastatic bone cancer still makes sense, is it worth the risk Fosamax now poses to those treating run of the mill osteoporosis?
While Fosamax looks less and less attractive for treating osteoporosis, the research on vitamin K-2 looks better and better. Recall from earlier newsletters that vitamin K-2 was first isolated from a Japanese regional delicacy called Natto. Anyone who hasn't grown up eating Natto will hesitate to describe it as a delicacy. It is a fermented soy bean dish eaten raw and is obviously an acquired taste. Natto is one of the rare foods that supply vitamin K-2. Natto consumption varies regionally in Japan and correlates closely with regional variations in fracture rates. Researchers think it's the vitamin K-2 in natto that stops the fractures. Additional studies have come out recently examining the benefit of vitamin K-2. They confirm the benefit seen in earlier works.
A 2005 paper, reported that K-2 treatment of a group of long term steroid users dropped the fracture rate from 41% to 13.3 %. [vii]
In another 2005 study 100 patients were treated with 45 mg of vitamin K-2, 1000 IU of vitamin D-2 and 600 mg calcium a day for 2 years. Over a two year period, twenty-two patients in the untreated control group suffered fractures, while only three fractures occurred among treated patients. [viii]
A January 2006 study compared the different medical treatments for osteoporosis with vitamin K-2 and showed it useful in treating serious osteoporosis but couldn't demonstrate effect in mild cases. [ix] Keep in mind when you use attempt to track changes in fracture rate you won't see much in the way of change in mild osteoporosis. It isn't until the disease is severe that fractures will occur often enough to see a change in rate.
The most important review of vitamin K-2's role in treating osteoporosis was published just this June in the high-falutin' Archives of Internal Medicine. This wasn't a study but rather a meta-analysis. Data from prior studies were pooled together to achieve greater statistical power. Thirteen trials were identified with data on bone loss, including 7 with fracture data. Twelve of the thirteen studies, found vitamin K supplementation reduced bone loss. Of the 7 trials reporting fracture data, 6 studies used 45 mg/day of K-2 and 1 used 15 mg/day. When the data from these 7 studies were pooled, the results showed that vitamin K-2 produced a 60% reduced risk in vertebral fractures, a 77% decrease in hip fractures, and an 81% reduction in all non-vertebral fractures. [x]
This is when you should say, “wow!” And this is about when you should be wondering why people are still taking Fosamax.
Avascular necrosis of the jaw is something you never want to get. The longer a person uses Fosamax the greater your odds of this nightmare occurring. If you are taking Fosamax and plan to undergo extensive dental work consider discontinuing the Fosamax, at least until the dental work is completed.
Some readers at this point will be thinking something along the lines of, “Good Lord, no way I'm using Fosamax.” Those readers should consider vitamin K-2 supplementation as one of several possible alternatives to using Fosamax.
[i] J Oral Maxillofac Surg. 2003 Sep;61(9):1115-7.
Pamidronate (Aredia) and zoledronate (Zometa) induced avascular necrosis of the jaws: a growing epidemic. Marx RE.
[ii] Ann Acad Med Singapore . 2004 Jul;33(4 Suppl):48-9.Bisphosphonates--a word of caution.
Robinson NA, Yeo JF.
[iii] J Oral Pathol Med. 2005 Feb;34(2):120-3.Avascular jaw osteonecrosis in association with cancer chemotherapy: series of 10 cases.
Bagan JV, Murillo J, Jimenez Y, Poveda R, Milian MA, Sanchis JM, Silvestre FJ, Scully C.
[iv] Ann Oncol. 2005 Jul;16(7):1207-8. Epub 2005 Apr 22. Jaw avascular bone necrosis associated with long-term use of biphosphonates.
Sanna G, Zampino MG, Pelosi G, Nole F, Goldhirsch A.
[v] Harefuah. 2005 Aug;144(8):536-9, 600, 599.[Avascular necrosis of the jaw bone after bisphosphonate therapy] Shlomi B, Levy Y, Kleinman S, Better H, Kahn A, Shtabsky A, Chaushu G.
[vi] Marx et al. Bisphosphonate induced exposed bone of the jaws: risk factors, recognition, prevention and treatment. J Oral Maxillofac. Surg 63:1567-1575, 2005
[vii] Iinuma N [Vitamin K2 (menatetrenone) and bone quality] Clin Calcium. 2005 Jun;15(6):1034-9.
[viii] Sato Y, Kanoko T, Satoh K, Iwamoto J Menatetrenone and vitamin D2 with calcium supplements prevent nonvertebral fracture in elderly women with Alzheimer's disease.
Bone. 2005 Jan;36(1):61-8. Epub 2004 Nov 24.
[ix] Shiraki M [A head-to-head comparative study for evaluation of effectiveness among drugs for osteoporosis]Nippon Ronen Igakkai Zasshi. 2006 Jan;43(1):45-7
[x] Cockayne S, Adamson J, Lanham-New S, Shearer MJ, Gilbody S, Torgerson DJ. Vitamin K and the Prevention of Fractures: Systematic Review and Meta-analysis of Randomized Controlled Trials.
Arch Intern Med. 2006 Jun 26;166(12):1256-61.