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Old 01-14-2008, 08:00 PM   #1
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Thumbs up Oral vs. IV bisphosphonates and risk of osteonecrosis of the jaw

There is an important new study on an issue important to many prostate cancer patients: the relationship of oral and intravenous bisphosphonate drugs and an infrequent but serious side effect known as osteonecrosis of the jaw (ONJ). Common bisphosphonate drugs and the usual method of administration are Fosamax (oral), Boniva (oral), Actonel (oral), Aredia (IV), and Zometa (IV).

While many of us prostate cancer patients are surprised to learn that we have significantly decreased bone density compared to other men our age , treatment with drugs that block testosterone (such as Lupron, Zoladex, Viadur, Trelstar, Eligard) often makes the problem substantially worse as testosterone is important in men for preserving bone density. (It takes a Bone Mineral Density (BMD) scan to diagnose loss of bone density - osteopenia (me) - a lesser degree of loss, or osteopenia. The BMD scan is not the same thing as the bone scan used to detect the spread of cancer.) Researchers believe the connection between the lower bone density and prostate cancer is a shortage of vitamin D that affects both.

The bisphosphonate drugs to me are wonder drugs because they fairly effectively counter loss of bone density, even while we are on hormonal blockade. Without these drugs, those of us who need hormonal blockade to control our prostate cancer would run a high risk of breaking our bones and developing osteoporosis with its humped over posture. With them, we can maintain a fairly healthy level of bone density. I was diagnosed with osteopenia in 2000 about ten months after starting Lupron as hormonal blockade. I have had a BMD nearly every year that checks density in four hip bones and four spinal bones (lumbar vertebra 1 through 4), and one year two spinal bones were in the osteoporosis range, one deeply into that range (T = -3.6) . Last fall every bone had improved to the healthy range except the one that had been -3.6, and that bone had improved to the middle of the osteopenia range, so you can see what the bisphosphonate drugs have meant to me. My bone density was actually greater on average in the hip and spine than for men my age without a diagnosis of decreased bone density. The two bisphosphonate drugs I have used are Fosamax, until October 2006, and Boniva since then and through the present.

However, in 2003 it was discovered that some osteoporosis and cancer patients on these drugs were experiencing ONJ. Their jaw bones were effectively disintegrating. The condition was fairly rare, and it seemed to be mostly associated dental surgery after IV and not oral bisphosphonate use, but a lot of us were scared. Many patients were afraid to use bisphosphonate drugs.

The new study appeared in the January 2008 edition of the Journal of the American Dental Association, with Dr. Zavras, from the Harvard School of Dental Medicine in Boston, as the senior author. Based on a study of medical claims by over 714,000 osteoporosis and cancer patients, the researchers concluded that oral bisphosphonate drugs actually reduce the risk of ONJ but that IV bisphosphonate drugs increase the risk substantially. You can pull up an abstract of the study by going to [url]www.pubmed.gov[/url] and searching for " zavras a [au] AND 2008 [dp] AND osteonecrosis ".

Personally, I would not hesitate to use one of the stronger IV drugs if I needed it, particularly since one of the doctors whose advice I follow has never seen an ONJ problem even with Zometa, by far the strongest bisphosphonate drug, based on limiting dosing to not more frequently than every three months.

While the researchers called for confirming research, it is reassuring to know that the oral bisphosphonates are apparently free of the ONJ problem.

Jim

Last edited by IADT3since2000; 01-14-2008 at 08:05 PM. Reason: Added reference to PubMed to get abstract right after initial posting.

 
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Old 01-15-2008, 08:21 PM   #2
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Re: Oral vs. IV bisphosphonates and risk of osteonecrosis of the jaw

Quote:
Originally Posted by IADT3since2000 View Post
There is an important new study on an issue important to many prostate cancer patients: the relationship of oral and intravenous bisphosphonate drugs and an infrequent but serious side effect known as osteonecrosis of the jaw (ONJ). Common bisphosphonate drugs and the usual method of administration are Fosamax (oral), Boniva (oral), Actonel (oral), Aredia (IV), and Zometa (IV).

While many of us prostate cancer patients are surprised to learn that we have significantly decreased bone density compared to other men our age , treatment with drugs that block testosterone (such as Lupron, Zoladex, Viadur, Trelstar, Eligard) often makes the problem substantially worse as testosterone is important in men for preserving bone density. (It takes a Bone Mineral Density (BMD) scan to diagnose loss of bone density - osteopenia (me) - a lesser degree of loss, or osteopenia. The BMD scan is not the same thing as the bone scan used to detect the spread of cancer.) Researchers believe the connection between the lower bone density and prostate cancer is a shortage of vitamin D that affects both.

The bisphosphonate drugs to me are wonder drugs because they fairly effectively counter loss of bone density, even while we are on hormonal blockade. Without these drugs, those of us who need hormonal blockade to control our prostate cancer would run a high risk of breaking our bones and developing osteoporosis with its humped over posture. With them, we can maintain a fairly healthy level of bone density. I was diagnosed with osteopenia in 2000 about ten months after starting Lupron as hormonal blockade. I have had a BMD nearly every year that checks density in four hip bones and four spinal bones (lumbar vertebra 1 through 4), and one year two spinal bones were in the osteoporosis range, one deeply into that range (T = -3.6) . Last fall every bone had improved to the healthy range except the one that had been -3.6, and that bone had improved to the middle of the osteopenia range, so you can see what the bisphosphonate drugs have meant to me. My bone density was actually greater on average in the hip and spine than for men my age without a diagnosis of decreased bone density. The two bisphosphonate drugs I have used are Fosamax, until October 2006, and Boniva since then and through the present.

However, in 2003 it was discovered that some osteoporosis and cancer patients on these drugs were experiencing ONJ. Their jaw bones were effectively disintegrating. The condition was fairly rare, and it seemed to be mostly associated dental surgery after IV and not oral bisphosphonate use, but a lot of us were scared. Many patients were afraid to use bisphosphonate drugs.

The new study appeared in the January 2008 edition of the Journal of the American Dental Association, with Dr. Zavras, from the Harvard School of Dental Medicine in Boston, as the senior author. Based on a study of medical claims by over 714,000 osteoporosis and cancer patients, the researchers concluded that oral bisphosphonate drugs actually reduce the risk of ONJ but that IV bisphosphonate drugs increase the risk substantially. You can pull up an abstract of the study by going to [url]www.pubmed.gov[/url] and searching for " zavras a [au] AND 2008 [dp] AND osteonecrosis ".

Personally, I would not hesitate to use one of the stronger IV drugs if I needed it, particularly since one of the doctors whose advice I follow has never seen an ONJ problem even with Zometa, by far the strongest bisphosphonate drug, based on limiting dosing to not more frequently than every three months.

While the researchers called for confirming research, it is reassuring to know that the oral bisphosphonates are apparently free of the ONJ problem.

Jim
Should patients who do not have cancer be concerned about taking bisphosphonate drugs because of the risk of developing ONJ?
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Old 01-16-2008, 12:32 PM   #3
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Re: Oral vs. IV bisphosphonates and risk of osteonecrosis of the jaw

Quote:
Originally Posted by able5 View Post
Should patients who do not have cancer be concerned about taking bisphosphonate drugs because of the risk of developing ONJ?
To me, as a layman, the risk for such patients appears to be extremely small. That's partly because non-cancer patients who are concerned about their bone density often take the oral medications like Fosamax, Boniva, or Actonel, instead of the IV medications, and the recent study goes a long way toward clearing these oral drugs from concern about ONJ, in fact suggesting that they are protective.

Even the IV drugs for such patients appear to be safe from my layman's viewpoint because the dosing is so much less frequent, therefore lower on a cumulative basis, than it is for cancer patients who are trying to prevent or roll back bone mets. Cancer patients trying to reverse already existing bone mets have in recent years taken the most powerful bisphosphonate, Zometa, as frequently as every three weeks, while those at high risk of bone mets might have the infusion every four weeks. In contrast, patients just trying to prevent or reverse osteoporosis have had success with yearly infusions of Zometa. We need to remember that the ONJ problem is still at least infrequent if not rare, even with IV patients, and whatever problem there is is usually associated with frequent dosage over a long period of time. Two medical oncologists expert in hormonal blockade with many patients on IV bisphosphonates have had no problems with ONJ. One attributes that do dosing no more frequently than every three months, and the other thinks his patients are successful because they also take calcium and vitamin D3 supplements that include several other associated minerals. That said, even patients on very frequent dosing do not often suffer from ONJ. (That doesn't mean they can forget about recommended precautions, like good dental hygeine and avoiding dental surgery if possible.)

It's important to balance the risks. The risks of osteoporosis and bone fracture are substantial and often quite serious, with hip fractures having a deserved reputation of leading to death within a year for many who suffer them. In contrast, the ONJ risk seems much less of a concern.

It will be interesting to watch how the media treat this study and how bone density experts react. Call me a skeptic, but I think the media will highlight the confirmation of added risk for the IV drugs and will neglect the great news about the oral drugs, or since the news is essentially positive, they won't mention it. The media love to push our emotional buttons and scare us, and they are not so fond of reassuring us.

Jim

 
Old 01-16-2008, 03:16 PM   #4
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Re: Oral vs. IV bisphosphonates and risk of osteonecrosis of the jaw

Quote:
Originally Posted by IADT3since2000 View Post
To me, as a layman, the risk for such patients appears to be extremely small. That's partly because non-cancer patients who are concerned about their bone density often take the oral medications like Fosamax, Boniva, or Actonel, instead of the IV medications, and the recent study goes a long way toward clearing these oral drugs from concern about ONJ, in fact suggesting that they are protective.

Even the IV drugs for such patients appear to be safe from my layman's viewpoint because the dosing is so much less frequent, therefore lower on a cumulative basis, than it is for cancer patients who are trying to prevent or roll back bone mets. Cancer patients trying to reverse already existing bone mets have in recent years taken the most powerful bisphosphonate, Zometa, as frequently as every three weeks, while those at high risk of bone mets might have the infusion every four weeks. In contrast, patients just trying to prevent or reverse osteoporosis have had success with yearly infusions of Zometa. We need to remember that the ONJ problem is still at least infrequent if not rare, even with IV patients, and whatever problem there is is usually associated with frequent dosage over a long period of time. Two medical oncologists expert in hormonal blockade with many patients on IV bisphosphonates have had no problems with ONJ. One attributes that do dosing no more frequently than every three months, and the other thinks his patients are successful because they also take calcium and vitamin D3 supplements that include several other associated minerals. That said, even patients on very frequent dosing do not often suffer from ONJ. (That doesn't mean they can forget about recommended precautions, like good dental hygeine and avoiding dental surgery if possible.)

It's important to balance the risks. The risks of osteoporosis and bone fracture are substantial and often quite serious, with hip fractures having a deserved reputation of leading to death within a year for many who suffer them. In contrast, the ONJ risk seems much less of a concern.

It will be interesting to watch how the media treat this study and how bone density experts react. Call me a skeptic, but I think the media will highlight the confirmation of added risk for the IV drugs and will neglect the great news about the oral drugs, or since the news is essentially positive, they won't mention it. The media love to push our emotional buttons and scare us, and they are not so fond of reassuring us.

Jim
Jim;
Forgive me if I'm not completely versed in this topic but I’ve read some articles describing complications following dental treatment in patients who were taking bisphosphonate medications. Do you have any comments on this?
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Last edited by able5; 01-16-2008 at 03:20 PM.

 
Old 01-16-2008, 07:58 PM   #5
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Re: Oral vs. IV bisphosphonates and risk of osteonecrosis of the jaw

Quote:
Originally Posted by able5 View Post
Jim;
Forgive me if I'm not completely versed in this topic but I’ve read some articles describing complications following dental treatment in patients who were taking bisphosphonate medications. Do you have any comments on this?
The ONJ risk (osteonecrosis of the jaw) is almost certainly the complication in bisphosphonate patients following dental treatment that you were reading about. It's the one that has been in the news for several years, basically, since late 2003/early 2004. ONJ can develop without dental treatment, but that seems to be what often triggers it.

There has been fairly strong evidence that ONJ was probably only a problem - a rare problem - related to intravenous (IV) bisphosphonates rather than the very widely used oral bisphosphonates. However, the existence of a handful of ONJ cases among oral bisphosphonate patients (among the many millions of prescriptions written) muddied the water and made it appear that the oral drugs were also involved in this problem. The new study mentioned in the original post makes this seem unlikely. It is possible that the few cases involved special circumstances or causes of ONJ unrelated to bisphosphonates that just happened to occur in a few oral bisphosphonate patients.

Just to be extra sure I asked my dentist to take a look at the panoramic x-ray he took for a checkup early last year to see if he could spot any signs of jaw bone trouble. He told me I had the jaw bone of a 20 year old! That may be related to the protective effect reported in the study for oral bisphosphonates.

Hope this helps.

Jim

 
Old 01-17-2008, 05:40 AM   #6
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Re: Oral vs. IV bisphosphonates and risk of osteonecrosis of the jaw

Quote:
Originally Posted by IADT3since2000 View Post
The ONJ risk (osteonecrosis of the jaw) is almost certainly the complication in bisphosphonate patients following dental treatment that you were reading about. It's the one that has been in the news for several years, basically, since late 2003/early 2004. ONJ can develop without dental treatment, but that seems to be what often triggers it.

There has been fairly strong evidence that ONJ was probably only a problem - a rare problem - related to intravenous (IV) bisphosphonates rather than the very widely used oral bisphosphonates. However, the existence of a handful of ONJ cases among oral bisphosphonate patients (among the many millions of prescriptions written) muddied the water and made it appear that the oral drugs were also involved in this problem. The new study mentioned in the original post makes this seem unlikely. It is possible that the few cases involved special circumstances or causes of ONJ unrelated to bisphosphonates that just happened to occur in a few oral bisphosphonate patients.

Just to be extra sure I asked my dentist to take a look at the panoramic x-ray he took for a checkup early last year to see if he could spot any signs of jaw bone trouble. He told me I had the jaw bone of a 20 year old! That may be related to the protective effect reported in the study for oral bisphosphonates.

Hope this helps.

Jim
Very helpful, thanks!
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