What should I know before starting Evenity?

Posted by bevlevvancouverbc @bevlevvancouverbc, Sep 4 6:24pm

Sept 4th, 2024
EVENITY
Like many of you, I have started from shock, to fearfulness to being
apprehensive what medication to take for severe osteo.
My numbers are L -5.2 hips -3.6 and -4.0
I hoped to be able to improve the numbers with diet and exercise.
Eventually I realized that it might be possible with osteopenia
but probably not with severe osteoporosis. Dr Beck
Onero program is not available in Vancouver, yet.
I am trying to learn hip hinge and squats
eventually I will find a a physical therapist/kinesiologist
with osteoporosis experience.
I do the stairs as often as I can, increasing how many times:
until hopefully add ankle weights.
My threadmill speed is 2.2mph..the goal is to increase every few weeks:
method: increase, count 24 seconds - go back to starting baseline – several times:
the goal is 2.5mph which is maintenance: and the larger goal is 3.1mph
which is osteogenic.
Diet: aside from the calcium and and Vit D: am looking into natural
sources of Vit K (Natto is not something I could consume regularly).
and have 5-6 prunes daily.
So…have finally made the decision to go with Evenity, if approved.
Have not used anything in the past: anabolic or anti resorptive.
Thank you for ladies from Canada for mentioning CTX. It is available
in Vancouver (sorry I didn’t mark down names) P1NP and TBS is not available.
Neither is REMS. I got a CTX – which we pay out of pocket here, so is
Vit D out of pocket unless it’s requested by a specialist. And TBS is
not available either. My CTX was in the 500.
Would be glad to hear comments, or shared stories.

Interested in more discussions like this? Go to the Osteoporosis & Bone Health Support Group.

@awfultruth

@spiderplant I did a quick check on the Evenity facebook group and everyone says 30 days because that's what their doctor told them. One person had a link to an Amgen site where they say their studies of going from Evenity to Prolia were done with Prolia starting 30 days after the last Evenity dose. No one mentioned a study on the issue. I stopped reading in that group when I found a comment by myself on the topic from 7 weeks ago. I had completely forgotten it. Pretty funny. In that comment responding to someone who was asking about waiting 3 months, I said ""In contrast, BMD in the total hip decreased by 5.4%, returning to the pretreatment level, and lumbar spine BMD decreased by 9.3% but remained above baseline in participants who received placebo for 12 months after stopping romosozumab 210 mg QM." That is from: https://academic.oup.com/jbmr/article/33/8/1397/7605217...
So that source is saying you lose most of your gains by 1 year. Your question is how much of that happens in 90 days?"
The upshot is you lose most of your gains in a year but what happens in those first weeks? Is there actually any direct evidence that the time after the last Evenity shot should be 4 weeks or two months or anything else? Hopefully not too much is lost right away!
Here's a chart showing declines of bone density after stopping different meds with no follow up meds. It appears to be based on results after a year as all the losses are in a straight line. So it is not of much use in our question here.

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Great chart @awfultruth. It shows that "locking in gains" with bisphosphonates is not short term at all. This was good timing for me as I decide on continuing with Reclast so thanks!

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@awfultruth

@spiderplant I did a quick check on the Evenity facebook group and everyone says 30 days because that's what their doctor told them. One person had a link to an Amgen site where they say their studies of going from Evenity to Prolia were done with Prolia starting 30 days after the last Evenity dose. No one mentioned a study on the issue. I stopped reading in that group when I found a comment by myself on the topic from 7 weeks ago. I had completely forgotten it. Pretty funny. In that comment responding to someone who was asking about waiting 3 months, I said ""In contrast, BMD in the total hip decreased by 5.4%, returning to the pretreatment level, and lumbar spine BMD decreased by 9.3% but remained above baseline in participants who received placebo for 12 months after stopping romosozumab 210 mg QM." That is from: https://academic.oup.com/jbmr/article/33/8/1397/7605217...
So that source is saying you lose most of your gains by 1 year. Your question is how much of that happens in 90 days?"
The upshot is you lose most of your gains in a year but what happens in those first weeks? Is there actually any direct evidence that the time after the last Evenity shot should be 4 weeks or two months or anything else? Hopefully not too much is lost right away!
Here's a chart showing declines of bone density after stopping different meds with no follow up meds. It appears to be based on results after a year as all the losses are in a straight line. So it is not of much use in our question here.

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I am surprised the chart from 2018 has Evenity on it when Evenity was not approved until 2019.

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@normahorn

I am surprised the chart from 2018 has Evenity on it when Evenity was not approved until 2019.

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@normahorn Yes, I was too. But research on it was going on back before 2010 if my memory is correct. And one of the main trials ended like in 2017 maybe? Anyway research and trials were going on for many years before that.

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@maieva

I am 66 years old and have been on Reclast for two years with some improvement in my scores, although the second year my spine score went down. My endocrinologist at Mayo Clinic discussed Evenity and Tymlos and I think I am going to try Evenity since it is one year and convenient to go once a month to the clinic to get the injections. I had concerns about the black box warnings regarding heart attack and stroke, but she reassured me that she has not heard of anyone experiencing this. I also have an appointment with my cardiologist to see what he says before I start. I don’t know what else to do and yes, I’m very nervous about taking this drug, but I know it’s supposed to give me big gains in my spine where I need it the most. Any additional advice?

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How many have seen that Australia has upped their warnings on heart issues with Evenity?
https://www.tga.gov.au/news/safety-updates/new-warnings-romosozumab-evenity-cardiovascular-risks

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@normahorn

How many have seen that Australia has upped their warnings on heart issues with Evenity?
https://www.tga.gov.au/news/safety-updates/new-warnings-romosozumab-evenity-cardiovascular-risks

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@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.

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@windyshores

@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.

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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

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@awfultruth

@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.

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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!

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@gravity3

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!

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

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@awfultruth

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

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Any confidence I had is shaken.

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@gravity3

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!

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@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

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