Are we overdosing Reclast???

Posted by awfultruth @awfultruth, Sep 9 5:35pm

Note: I have posted this elsewhere in comments but I don't think it was widely seen so I'm posting this here as it's own discussion.

Now to the point, YES, I think Reclast is being overdosed and that the the large dose given once a year is probably responsible for a lot of the bad side effects some people experience.
There is strong evidence in studies that lower dosages and altered infusion schedules produce very similar results and in one case superior results to the standard 5 mg dose of Reclast.
It becomes clear from studying the papers below that the motivating factors behind the 5mg yearly dose is convenience, patient compliance, money and they claim the greater good for the most people. They do not consider intelligent individualized medicine. Nor do any of these papers report anything other than temporary discomfort as a side effect. None of them seriously consider that a lower dose might be safer.

Before I list the papers supporting my argument that lower doses could be effectively and safely used I want to mention that maybe severe long term side effects are rare events and don't merit this attention. The short term flu like etc reactions are acknowledged but long term life changing side effects don't seem to be well reported for Reclast. I do not know how often or in what percentage of Reclast users these occur. Some reports could be coincidence and not due to Reclast at all. I do not know how to determine how real the threat of long term serious consequences is. So, for the purposes of this post I'm considering the serious long lasting adverse side effects of standard dosing of Reclast to be real, of unknown frequency and something to consider and try to avoid.

Here are three papers showing lower doses work just as well.

The first one compares 3 different doses and shows that 1mg does well, 2.5mg does best and 5mg does ALMOST as well as 2.5 mg. All three were one dose with result at one year.
https://academic.oup.com/jcem/article/97/1/286/2833555...
The second one alters dosing schedules depending on dosage. Combined with the paper above this is great information. They used dosages as small as 0.25mg quarterly with the same result as the large annual dose. It's behind a paywall but you can get a free account and get three free articles a month.
https://www.nejm.org/doi/pdf/10.1056/NEJMoa011807...
The third one compares 2mg to 4mg and concludes that we should stick with 4mg. BUT, if you dig into the details you see that there is reason to rethink their conclusion. Yes there is a tiny advantage to 4mg in the spine BUT there is a tiny advantage to the femur neck and total hip for the 2mg. Hardly what would make me call the 4mg superior and certainly not a significant difference. The difference in the spine is between 2mg gains 4.86% and 4mg gains 5.35%. So a gain of about 5% with either dose. As I said it flips the other way with the hips but they do not consider that even though their study shows it.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8420937/
What also needs to be considered is how often we are dosing Reclast and how the annual dose for osteoporosis may be too frequent and may be putting people at unnecessary risk of long term side effects.
I wanted to list a fourth paper showing that Reclast doesn't usually need to be given annually. That it often lasts as an effective dose for 18-24 months. I'm almost certain I saw a paper on this but I cannot find it now. What would be best IMO is to monitor CTX and only give another infusion when the CTX reaches a level indicating bone turnover is speeding up too much.

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

@windyshores

I had 1 mg on the second infusion. I did not get a fever but, oddly, I felt sicker. That was the immediate reaction, for the first few days, that did not concern me.

I have a lot of health issues, many of them relevant to how my body reacts to Reclast: kidney disease, afib, lupus, possible scleroderma, GERD/reflux. asthma, neuropathy/paresthesias, "central" vertigo and migraine (from the brain), tinnitus etc. etc. I don't want anyone else to conclude that Reclast will be difficult for them.

Tymlos is the only medication I seem to be able to finish. Thank heavens the titration worked. The study posted about 2mg vs 4mg was reassuring though I would have done the full dose if I could.

I'll get a DEXA in April to see where I am though having several fractures the DEXA usefulness is limited.

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Thank you for the reply. It is good to know you are tolerating it. You have a great endo tailoring individual care with your overall health status in mind. Tolerability to any osteodrug varies so much among different individuals. @awfultruth presented a great topic for discussion here.

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@kay44

Just want to say "Thank you" for posting this. So helpful
Reclast has been benefit to me, but it created a great sadness in my life about appearance with my teeth. I was also very scared to take such high dose because of kidneys.

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What is the issue with your teeth?

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@gretchen1018

What is the issue with your teeth?

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Yes please tell us what issues you had with your teeth ?

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Presentation by Dr. Susan Ott
Top Ten Important Things About Osteoporosis That Many Doctors Don't Know


At the 19:38 mark. #9 One Dose of Zoledronate...
Dr. Ott discusses research using lower doses of Zolendronate

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@19kcm56

Presentation by Dr. Susan Ott
Top Ten Important Things About Osteoporosis That Many Doctors Don't Know


At the 19:38 mark. #9 One Dose of Zoledronate...
Dr. Ott discusses research using lower doses of Zolendronate

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@19kcm56 I watched the video and there was a difference in the middle of the graph (in the middle of 10 years) where the 1 mg dose line was much lower than the 5mg line.

I have had two low dose infusions (1 mg each) due to kidneys and afib. I would certainly like to believe that is enough but have strong doubts.

I do believe the 5mg dose was chosen because it covers everyone (like the Evenity dose)- even though it might overdo it for us lightweights.

Reclast can be given at a low dose fairly easily. But that means, at this point, with the protocols in place, that doctors want that low dose given more frequently- 1 mg 4-5 times/year for instance. This would overwhelm the medical system, the cancer infusion centers and the insurance system.

I am not saying there should not be lower doses. But medical appropriateness is clearly not the top priority. Nuance in dosing is expensive and administratively difficult, unfortunately.

Personally I am not sure the lower dose lessens side effects either!

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Some of us are rightfully questioning the one size fits all approach. I had cataract surgery without sedation so any would have been more than I needed. Someone else I know was given the standard dose based on her weight (high BWI). That was too much for her. For the second eye, she was given a greatly reduced dosage which was far better for her and for the surgeon. Thankfully, they learned from the first eye and acted accordingly. We deserve to be treated as individuals, to a degree, with osteoporosis meds. If lower doses are reasonably feasible, we should have the option to choose those. We are more important than the system.

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@normahorn

Some of us are rightfully questioning the one size fits all approach. I had cataract surgery without sedation so any would have been more than I needed. Someone else I know was given the standard dose based on her weight (high BWI). That was too much for her. For the second eye, she was given a greatly reduced dosage which was far better for her and for the surgeon. Thankfully, they learned from the first eye and acted accordingly. We deserve to be treated as individuals, to a degree, with osteoporosis meds. If lower doses are reasonably feasible, we should have the option to choose those. We are more important than the system.

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@normahorn I wrote "I am not saying there should not be lower doses." No argument here. But I am not as hopeful about that change happening, and not sure how many patients need a lower dose either. It does look like the higher dose works better over 10 years.

I have lower doses of every single medication I have taken in the last 25 years. Usually 20-25%. I have also done that with every osteoporosis medication but partly because of medical necessity. If people cannot handle the full dose, they should work with their doctor or find another doctor. Most people do handle Reclast without problems.

In terms of increased frequency of infusions, I would be concerned about the effect on cancer care . A possible course to advocate for would be a lower dose on the same schedule as the full dose- once or twice a year. I have been told by an endo and by an infusion nurse that 2mg doses are common. Can't people ask for that then?

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@windyshores

@normahorn I wrote "I am not saying there should not be lower doses." No argument here. But I am not as hopeful about that change happening, and not sure how many patients need a lower dose either. It does look like the higher dose works better over 10 years.

I have lower doses of every single medication I have taken in the last 25 years. Usually 20-25%. I have also done that with every osteoporosis medication but partly because of medical necessity. If people cannot handle the full dose, they should work with their doctor or find another doctor. Most people do handle Reclast without problems.

In terms of increased frequency of infusions, I would be concerned about the effect on cancer care . A possible course to advocate for would be a lower dose on the same schedule as the full dose- once or twice a year. I have been told by an endo and by an infusion nurse that 2mg doses are common. Can't people ask for that then?

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Basically I am saying, if there is good reason for a lower dose, women (and men) should be empowered to request a lower dose. If a doctor says no, find another doctor. It is easier to effect change that way than to get the company, infusion center or system to change. Change from within.

To say "we are being overdosed" is a passive position leaving anger and fear. There is a more active approach- ask for a lower dose. For most this is not necessary but for some of us, it is.

In fact, we can legally stop an infusion at any point. The doctor might not be pleased, but we can do that at 1mg, 2mg, or 3.

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@windyshores

Basically I am saying, if there is good reason for a lower dose, women (and men) should be empowered to request a lower dose. If a doctor says no, find another doctor. It is easier to effect change that way than to get the company, infusion center or system to change. Change from within.

To say "we are being overdosed" is a passive position leaving anger and fear. There is a more active approach- ask for a lower dose. For most this is not necessary but for some of us, it is.

In fact, we can legally stop an infusion at any point. The doctor might not be pleased, but we can do that at 1mg, 2mg, or 3.

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@windyshores When I entitled this discussion "Are we overdosing Reclast???" I certainly did not intend it to be a "passive position leaving anger and fear". Although as I write this it occurs to me that anger and fear are quite reasonable responses to our situation with osteoporosis.

But to get back on topic I did not intend it to be a passive position and I do not see the responders here being passive. Each person is going to respond in their own way to health information. If someone started a grass roots movement that advocated for more careful dosing of medications I would see that as great. If someone talks to their doctor about whether the standard dosage is best for them, then I see that as great too. If another person thinks this is nonsense, well, I'll just have to accept that also, won't I?

For myself I've decided I want to try risedronate or alendronate for a year and then do another round of Evenity. I'm wanting to follow Dr Michael McClung's suggested strategy of using a less powerful bisphosphonate rather than a more powerful and longer lasting one like Reclast to proceed a round two of Evenity. And I'm doing a little dance with my doctor trying to make this happen.

BTW thanks to @19kcm56 for posting the link to Dr Susan Ott who is another doctor having concerns about possible Reclast overdosing. I had seen her work before and forgotten about it.

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@awfultruth. I for one want to thank you for the thread and raising the question about potential overdosing. The first step is recognizing that there may be a problem and then looking for solutions if a problem does exist. Making us aware of the issue allows us to discuss with our physicians rather than just blindly following what has been done. Maybe we can get them to also think about the issue.

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