1. < Osteoporosis & Bone Health

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.

gravity3 | @gravity3 | Oct 12 4:04am
In reply to @newenglandtransplant "@gravity3 I have been curious about this as well, so I took a look at the..." + (show)
@newenglandtransplant

@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

Jump to this post

Thank you for this great information. I will have a shot of prolia next week and I may have a second one and thinking another round of Evenity and then a bisphosphonate.

REPLY
windyshores | @windyshores | Oct 12 4:58am
In reply to @maieva "I am 66 years old and have been on Reclast for two years with some improvement..." + (show)
@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?

Jump to this post

My doc said there was no rush to get on Reclast after Evenity because it takes time for Evenity to mineralize. I assume also, since Evenity keeps CTX down, that we want to make sure the CTX isn't too low when we start the Reclast (or Prolia) but I don't know. Evenity is new, and people finishing Evenity is even newer, so I think we will know more in a few years.

REPLY
windyshores | @windyshores | Oct 12 5:13am
In reply to @newenglandtransplant "@gravity3 I have been curious about this as well, so I took a look at the..." + (show)
@newenglandtransplant

@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

Jump to this post

@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.

REPLY
1 reply
windyshores | @windyshores | Oct 12 5:19am
In reply to @normahorn "I did not say that the info was new; I commented that Australia upped their warning..." + (show)
@normahorn

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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@normahorn I just wanted to make sure people reading this didn't think the risk had increased. Instead the language changed. I personally felt a little alarmed when I saw your post, thinking some new info had been found in Australia. Some people might not read the actual content and react to the post itself so I just wanted to explain the content.

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1 reply
newenglandtransplant | @newenglandtransplant | Oct 12 7:20am
In reply to @windyshores "@newengland transplant I read the part of the ARCH study you linked and it says Evenity..." + (show)
@windyshores

@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.

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@windyshores the study protocol doesn’t specify when alendronate should be started, it only describes how the study was conducted. It’s an important difference. And even that took me a while to piece together from the protocol.

I tend to agree with you that we’ll know more over time as more studies are conducted and more real world data emerges. Has your doctor given you more insights into evenity mineralizing over time? That’s the kind of data that would be so interesting to see.

REPLY
njhornung | @normahorn | Oct 12 9:01am
In reply to @windyshores "@normahorn I just wanted to make sure people reading this didn't think the risk had increased...." + (show)
@windyshores

@normahorn I just wanted to make sure people reading this didn't think the risk had increased. Instead the language changed. I personally felt a little alarmed when I saw your post, thinking some new info had been found in Australia. Some people might not read the actual content and react to the post itself so I just wanted to explain the content.

Jump to this post

I feel very confident that Australia did not make the change on a whim but had a basis for it. You may disagree.

REPLY
1 reply
windyshores | @windyshores | Oct 12 10:00am
In reply to @normahorn "I feel very confident that Australia did not make the change on a whim but had..." + (show)
@normahorn

I feel very confident that Australia did not make the change on a whim but had a basis for it. You may disagree.

Jump to this post

@normahorn it's the same studies done already and 5 years of Evenity on the market has not, to my knowledge, revealed major CV problems. I have no idea why they expanded the content.

As a patient who has used it and may use it again, I would be interested in anything you see that is substantive that indicates increased CV risk. Are you able to find out why Australia did this change?

I cannot agree or disagree without more info.

REPLY
windyshores | @windyshores | Oct 12 10:06am
In reply to @maieva "I am 66 years old and have been on Reclast for two years with some improvement..." + (show)
@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?

Jump to this post

@newenglandtransplant my doc said there was "no rush" to get on Reclast after Evenity because it "takes time to mineralize" but gave me a limit of two months to wait. That's all I know. I waited exactly two months. My doc doesn't do bone markers. My CTX runs kind of low even at baseline which is interesting. It may be affected by kidneys although kidney disease would tend to raise it.

REPLY
awfultruth | @awfultruth | Oct 12 12:22pm
In reply to @gravity3 "I just finished Evenity. My endocrinologist wanted me to wait 5 mo. But I was concerned...." + (show)
@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 (and also @newenglandtransplant, @windyshores, and @normahorn) As you mention the Amgen - Prolia website does clearly state that a wait of 30 days plus or minus 7 days was used for the Frame study. "*In the FRAME study, Prolia® was initiated 1 month +/- 7 days from the last monthly dose of EVENITY®." So a period of 23-37 days was used.
From: https://www.evenityproliasa.com/evenity-to-prolia-transition

I tried yet again to find more info on how long after stopping Evenity before you go to the next med. I found no clear discussion of this. I looked at one or two studies that went beyond 1 year and had a follow up med after Evenity. Maybe I was just looking at the Frame study or the extension to it. Anyway I could not find a statement specifying a time period. What I did see is that there is an implication that a 1 month period after Evenity was used. The studies would specify months 1-12 and then 13-24 or endpoint 24 etc. If patients were taking the next med starting at any date other than the next month I believe it would have been specified because when you state months 1-24 it does imply that months 13-24 were on the follow up med. My unverified conclusion is that those studies were doing the next med at 1 month after the last Evenity shot.

That does not prove 1 month is ideal but it does show what we have data for. There may be no study data available for any other length of wait time?

And here's Amgen saying start follow up at 1 month.

REPLY
1 reply
hopefullibrarian | @hopefullibrarian | Oct 12 12:34pm
In reply to @awfultruth "@spiderplant I did a quick check on the Evenity facebook group and everyone says 30 days..." + (show)
@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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Hi awfultruth,

Thank you for sharing this.
Just before I read your comment, I just so happened to be looking at the page on the Amgen site that the person in the Evenity Facebook group referred to: https://www.evenityproliahcp.com/evenity-to-prolia-transition

Like many of us on this forum, I'm considering what comes next for me post Evenity. The 12 months seems to be going pretty fast. I had my 9th injections almost 2 weeks ago. I'm trying to make sense of the research that's out there.

Unless I'm reading it wrong, on the chart you shared, it looks like BMD post Alendronate was the best. That's likely the result for patients who have only ever taken Alendronate. I'd like to read the full study, but it's behind a paywall. 🙁 Here's a link behind the paywall that I found for the study: https://www.nature.com/articles/s41574-018-0087-0

While I was searching for the chart online, it led me to something interesting that might be helpful for some of you. It's a summary from part of a 2018 meeting of the American Association of Clinical Endocrinology (AACE) International, Italian Chapter which compiles numerous studies on anabolic agents. It references the study containing the chart you provided as well as Dr. Ben Leder's research on combination and sequential therapies and many others. It brings together a lot of information in one place. For anyone who's interested, here's the link (the notes are in English): https://www.associazionemediciendocrinologi.it/images/eventi/congressi-nazionali/2018/relazioni/aace/2-bone/09_chiodini.pdf

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