[Laurel]

The folks administering the Neratinib trial will allow bisphosphonates outside of the SWOG trial in cases of "documented" osteopenia or osteoporosis. No one may remain in SWOG and participate in the Neratinib trial. If you have a bone density test result that supports the diagnosis of osteopenia/porosis you may continue the bisphosphonate prescribed by your M.D., and even began receiving one for the condition. They are insisting you begin your bisphosphonate treatment for the documented osteopenia/porosis 2 weeks prior to beginning the Neratinib trial. I have not been able to secure a method around this restriction, so I will not participate in this trial and will remain in SWOG. I did have a bone density this week which in the words of my trial nurse at Hershey who reviewed the scans, "your bones are so tough nothing is going to break them!"

If I wish to pursue the Neratinib trial I must discontinue the Clondronate, wash out, and begin the trial. If after several months on an A.I. without a bisphosphonate I develop osteopenia, I would be permitted a bisphosphonate to treat the condition, at least that is my understanding, but I'd verify this if you are on an A.I. or are menopausal. To answer your question whether it is protocol to prescribe a bisphosphanate in conjunction with an A.I. in the absence of documented osteopenia, it is not. You can talk your Onc. into giving it to you "off label" which leaves you at the mercy of your insurance carrier to approve payment or not. Capital Blue Cross would approve Fosamax under these conditions for me.

I suggest you call a center where they are running this trial and begin a dialog and let me know if you are encountering the same restrictions.