HER2 Support Group Forums - View Single Post - Phase II Bisphonates Trial-Should I participate?

AlaskaAngel · 06-28-2007, 11:24 AM

I am hoping that you get some responses from others who are doing this trial or are considering it. In the meantime I will mention questions I have about it.

The incidence of osteonecrosis of the jaw in those taking bisphosphonates is less than 8% in studies so far, but the study involves the use of IV bisphosphonates rather than oral I think? The dose IV is massively greater than the oral dose and is of more recent use than the older oral bisphosphonates, so I don't know that the new trial really recognizes that the percentage of necrosis risk from studies so far may not be the same at all. So that would be one thing to ask about. One thing that seems clear from the studies that have been done so far is that the longer the use of a bisphosphonate or the bigger the dose, the more cases of osteonecrosis of the jaw that there are.

Part of the question I have about this trial is based on the fact that bisphosphonates are permanent in the body. I would guess that every person entering the study is advised to have any need for extractions or root canals done prior to entering the study since those seem to be triggers for the development of osteonecrosis. But the study is being done with NED people and if somewhere down the road during the study you need extraction or a root canal, stopping the bisphosphonate and then having the procedure doesn't mean that the accumulated bisphosphonate won't cause osteonecrosis. So... it is a very different thing to be taking IV bisphosphonates for an established need, such as significant osteopenia/osteoporosis or known mets versus taking such drugs as someone who has good bones and is NED.

Then too (as I understand it) less than 50% of those who ever do have mets would even ever have bony mets.

I probably just need to understand better why the people behind this trial are willing to expose the thousands of early stage NED women being recruited for it to what seems to me to be such relatively high risk.

Is it true 2 of the major researchers behind the trial receive grants from the pharmaceutical companies as part of their research? That probably doesn't mean much, though, if most serious researchers nowadays have to depend on some support from pharmaceutical companies.

From what I saw about this trial is that it is a Phase III trial, not phase II?

AlaskaAngel

06-28-2007, 11:24 AM	#4
AlaskaAngel Senior Member Join Date: Sep 2005 Location: Alaska Posts: 2,018	Bisphosphonate trial I am hoping that you get some responses from others who are doing this trial or are considering it. In the meantime I will mention questions I have about it. The incidence of osteonecrosis of the jaw in those taking bisphosphonates is less than 8% in studies so far, but the study involves the use of IV bisphosphonates rather than oral I think? The dose IV is massively greater than the oral dose and is of more recent use than the older oral bisphosphonates, so I don't know that the new trial really recognizes that the percentage of necrosis risk from studies so far may not be the same at all. So that would be one thing to ask about. One thing that seems clear from the studies that have been done so far is that the longer the use of a bisphosphonate or the bigger the dose, the more cases of osteonecrosis of the jaw that there are. Part of the question I have about this trial is based on the fact that bisphosphonates are permanent in the body. I would guess that every person entering the study is advised to have any need for extractions or root canals done prior to entering the study since those seem to be triggers for the development of osteonecrosis. But the study is being done with NED people and if somewhere down the road during the study you need extraction or a root canal, stopping the bisphosphonate and then having the procedure doesn't mean that the accumulated bisphosphonate won't cause osteonecrosis. So... it is a very different thing to be taking IV bisphosphonates for an established need, such as significant osteopenia/osteoporosis or known mets versus taking such drugs as someone who has good bones and is NED. Then too (as I understand it) less than 50% of those who ever do have mets would even ever have bony mets. I probably just need to understand better why the people behind this trial are willing to expose the thousands of early stage NED women being recruited for it to what seems to me to be such relatively high risk. Is it true 2 of the major researchers behind the trial receive grants from the pharmaceutical companies as part of their research? That probably doesn't mean much, though, if most serious researchers nowadays have to depend on some support from pharmaceutical companies. From what I saw about this trial is that it is a Phase III trial, not phase II? AlaskaAngel