Evenity Advice?

@normahorn this info doesn't look new but seems to reiterate the results of the FRAME and ARCH studies. It looks like they did add some new language to expand the warning but it is still based on the same two studies. From your linked update:

"The Australian, European Union and United States product information documents all describe the results of 2 pivotal studies providing data about the potential risk of major adverse cardiac events associated with romosozumab.1,2 There was a higher rate of major adverse cardiac events (a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke) associated with romosozumab in one trial but not the other. The disparity between these 2 trials has been a focus for regulators assessing the safety of this medicine."

I have seen one article that accounts for the difference between Evenity and alendronate as being due to cardiovascular protective factors from alendronate use, and another article claiming it was due to chance. Clearly more research is needed.

I also have read that while cardiovascular risk has been the focus of research on Evenity, the effects of inhibiting sclerostin throughout the body have not been adequately studied (bone marrow inflammation, B cell suppression, osteoarthritis etc.) But those problems seem not to have emerged in any significant way since it went on the market.

I am cautious: I took it for 4 months and hope to be able to do that again.

@spiderplant Like you, I have seen little online about how long after the last Evenity shot you should wait to start a follow up drug. My doc told me to start 30 days after I finish Evenity but offered no reason why or what would happen if you waited 2 or 3 months. I haven't been searching for info on that but if you find any please post it.
I've decided on Risedronate. It was my wish based on Dr Michael McClungs logic on the subject as stated in an open mic discussion during the last Santa Fe Bone Conference. He recommended it if you want to do another round of Evenity with a year or so period in between which is what i want to do.

I just finished Evenity. My endocrinologist wanted me to wait 5 mo. But I was concerned. Checked the prolia website and the say 1 months and 7 days. I emailed him my concern and he called me and said he had contacted some other "bone docs) and some do 6 mo and some 1 mo. I hate that their is so much is unknown. Scary!

@gravity3 Wow, I have never heard of that nor can I imagine why that would be advised.

I just finished Evenity. My endocrinologist wanted me to wait 5 mo. But I was concerned. Checked the prolia website and the say 1 months and 7 days. I emailed him my concern and he called me and said he had contacted some other "bone docs) and some do 6 mo and some 1 mo. I hate that their is so much is unknown. Scary!

@gravity3 I have been curious about this as well, so I took a look at the ARCH study, The attached graphic is from the study protocol. Based on my interpretation of the protocol, romosozumab injections were administered at visits on day 1 then at monthly visits 1 - 11. A supply of alendronate was provided at the month 12 visit. So it looks like alendronate was started one month following the last romosozumab injection, though the protocol doesn’t explicitly state that.

From a Quick Look at the FRAME study, it appears denosumab was started at the month 12 visit, so also one month after the last romosozumab injection.

I would be really wary of waiting 6 months to start an antiresorptive if the doctor isn’t able to provide a solid rationale.

I used the following link to get to the ARCH study results: https://www.nejm.org/doi/full/10.1056/NEJMoa1708322

Study protocol:
https://www.nejm.org/doi/suppl/10.1056/NEJMoa1708322/suppl_file/nejmoa1708322_protocol.pdf

@gravity3 I have been curious about this as well, so I took a look at the ARCH study, The attached graphic is from the study protocol. Based on my interpretation of the protocol, romosozumab injections were administered at visits on day 1 then at monthly visits 1 - 11. A supply of alendronate was provided at the month 12 visit. So it looks like alendronate was started one month following the last romosozumab injection, though the protocol doesn’t explicitly state that.

From a Quick Look at the FRAME study, it appears denosumab was started at the month 12 visit, so also one month after the last romosozumab injection.

I would be really wary of waiting 6 months to start an antiresorptive if the doctor isn’t able to provide a solid rationale.

I used the following link to get to the ARCH study results: https://www.nejm.org/doi/full/10.1056/NEJMoa1708322

Study protocol:
https://www.nejm.org/doi/suppl/10.1056/NEJMoa1708322/suppl_file/nejmoa1708322_protocol.pdf

I did not say that the info was new; I commented that Australia upped their warning on cardio vascular risks. What you make of that is up to you

@newengland transplant I read the part of the ARCH study you linked and it says Evenity "followed by alendronate" but does not specify timing. Does the FRAME study specify when alendronate should be started? I imagine there is leeway depending on CTX and other markers a month after Evenity is stopped.

ps That link discusses studies on cardiovascular risk which would help people who are scared of the black box warning. No calcification of blood vessels has been seen in studies so far and the link mentions that the difference between Evenity and alendronate results may have been because alendronate is slightly protective. It also mentions the FRAME study where there was no difference is CV risk between Evenity and placebo. The CV risk remains theoretical in other words.