Log in to post a reply
Jun 28, 2007 02:34PM
Thanks for the link posted earlier. I'd like to get some feedback with your impressions about the clinical trial some are considering. It may be a trial that is truly important and needed so I'm hoping that your responses will give that serious consideration too. I'm genuinely trying to figure out whether the trial, despite some drawbacks, is worthy.
Here's my concerns:
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 done earlier 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 (or even long after 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.
I also wonder how relevant the trial results will be if the adjuvant group that is enrolled is more unlikely to ever have mets (much less bony mets)?
If I were doing the trial, for sure I'd be asking about the test mentioned in the link earlier here, to get some idea what my risk is.
As I understand it, less than 50% of those who ever do have mets would even ever have bony mets. Yet this trial will expose thousands of adjuvants to the bisphosphonates.
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. I could understand a little better maybe if this trial were being done with those who already have a legitimate reason for doing the bisphosphonates.
Thanks for any comments. It would be nice if an experienced news reporter would ask some of these questions of the researchers conducting this trial for us.
12/3/2001, DCIS/IDC, Left, 1cm, Stage IA, Grade 3, 0/1 nodes, ER+/PR+, HER2+ (IHC)
1/3/2002 Lumpectomy: Left; Lymph node removal: Left, Sentinel
3/12/2002 Adriamycin (doxorubicin), Cytoxan (cyclophosphamide), Fluorouracil (5-fluorouracil, 5-FU, Adrucil)
11/15/2002 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)