Clinical Trial for Biophosphonates 9-25-09

Hey everyone,

The 3 year Clinical Trial that Laurie is participating in is designed to determine if adding a biophosphonate to hormonal therapy and/or chemotherapy will help prevent breast cancer from spreading to the bones or other parts of the body. About 4,500 women are taking part in this study. There are 3 different groups within the study, each being given a different type of biophosphonate for 3 years as note below. (there is no placebo in this study)

1. 4 mg infusion of zoledronic acid through a needle in the vein every 4 weeks for the first 6 months and then once every 3 months for the other 30 months
2. 1600 mg of clodronate by mouth (2 tablets) every day for 36 months
3. 50 mg of ibandronate by mouth once every day for 36 months (marketed as Boniva here in US, similar to Actonel)

Biophosphonates are a class of drugs that prevent the bone from breaking down. Low doses are used for osteoporosis here in the US and higher dosages are used for bone cancers (currently zoledronic). This clinical trial is using higher dosages. For example, someone taking Boniva for osteoporosis (you probably have seen Sally Fields in a TV ad on this) would take 2.5 mg daily or 150 monthly. As you see under #3 above, participants in this study take 50 mg daily. The purpose of the study is to see if biophosphonates should be added to the treatment regiment for breast cancer patients, and if so, which one of these works the best (best stats with least amount of side effects). Side effects from the 3 options vary but overall, side effects include nausea, vomiting, reflux and diarrhea. Uncommon, but serious side effects include the possibility of a specific type of damage to the jawbone (osteonecrosis of the jaw) and damage to an unborn child or a baby who is breastfeeding (not a concern for Laurie!). They will run routine blood tests every month for the first 6 months and then every 3 months thereafter. The blood tests will check normal levels as well as serum creatinine to ensure the kidneys are working properly.

For those medical folks out there, you know that bisphosphonates prevent the breakdown of bone by bone cells called osteoclasts. For the rest of us, Laurie’s dentist explained it a little easier to understand: “The bones are like roads. Before they are repaved, a layer is removed, and then a new layer of asphalt is added. Bones are similar. There are cells that are breaking down the bone, and then new cells are created. The biophosphonates decrease the activity of the cells that are “breaking down or removing” bone density and since the new cells are still being created, the bones become more dense and stronger.”

The medication she is taking is being used in Canada, the United Kingdom and Italy, where it is marketed as Bonefos, Loron and Clodron. Oral Bonefos is approved in 67 countries outside the United States largely for the treatment of tumor-induced osteolysis and hypercalcemia. So far, nearly 20 years of use and 300,000 patient-years of experience with Bonefos have been accumulated worldwide.

So, now you know a bit more about what and why Laurie is participating in this clinical trial. The bottom line is that she hopes to provide data that will one day lead to a cure for others that may experience what she has already gone through.

May God continue to bless you as He has so richly blessed our family!

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