OSTEOPOROSIS AND DRUG CHANGES

[lenora]

I'm female and age 75. I'm presently recovering from 5 pelvic fractures and a vertebra that has just had it's second fracture.

My question: I have been on Fosamax since it's introduction since I've had osteoporosis from probably age 40. Since the recent fractures my Internist wants to change me from Fosamax to Prolia (six month infusion). To be honest, I've had two friends who were adversely by the 6 month infusions.

I'm quite interested in any experiences anyone (male or female) have had with the likes of Prolia. On the one hand it's easy....although I will have to go to a profusion center, but on the other I'm afraid of side-effects. I have a history of FM and I really don't want that not-so-little problem back again.

Feedback would be appreciated. Very much so. Thanks. Lenora

 

[Shanti1]

Hi Lenora,
The generic name for Prolia is denosumab. My husband has been on monthly injections of denosumab (brand name Xgeva) on and off for five years as part his cancer treatment. Although the list of side effects is scary, he hasn't experienced any of them.

He takes it along with other bone supporting nutrients such as calcium, vit D, vitamin K2, magnesium, and trace minerals. Apart from being needed for bone formation, these nutrients help maintain blood calcium levels and a low/normal parathyroid hormone (PTH) level. Low calcium and high PTH are associated with an increased incidence of osteonecrosis of the jaw (ref)(ref). I'm sure you are familiar with osteonecrosis of the jaw as it is also a talked about side effect for the bisphosphonates like Fosamax.

Prolia (denosumab) inhibits bone reabsorption by osteoclasts. The enzyme alkaline phosphatase (alk phos) is commonly tested for on a chem screen and is a marker for bone turnover, biliary issues, or intestinal inflammation. When my husband is on denosumab, his alk phos plummets to about 15 (39-117 IU/L), indicating that the medication has vastly reduced his bone turnover. He has been in the osteopenia category since 2016 and has remained stable.

 

[Shanti1]

btw Prolia is given as a subcutaneous injection, are your friends certain they received Prolia? If they are saying they received an infusion, they probably received a different drug.

 

[YippeeKi YOW !!]

He takes it along with other bone supporting nutrients such as calcium, vit D, vitamin K2, magnesium, and trace minerals. Apart from being needed for bone formation, these nutrients help maintain blood calcium levels and a low/normal parathyroid hormone (PTH) level. Low calcium and high PTH are associated with an increased incidence of osteonecrosis of the jaw (ref)(ref). I'm sure you are familiar with osteonecrosis of the jaw as it is also a talked about side effect for the bisphosphonates like Fosamax.

This is really good input @Shanti1 ....

FOSAMAX, PROLIA, BONIVA ….BISPHOSPHANATES GENERALLY …
The problem with all of these is that while they increase bone thickness by slowing bone resorption, they actually reduce bone density, and produce thicker, but more porous, brittle bones, which leads to easy fractures.

While essential in the treatments of some cancers, there are other ways to boost bone strength and density thru the use of various minerals like calcium, magnesium, phosphorus, etc , that don’t cause some of the numerous side effects of these treatments, and don’t lead to deterioration of bone density and overall strength.

At the very least, patients prescribed any of the bone 'density' drugs should heed @Shanti1 's extremely sensible and well-considered recommendations and increase their intake of bone supportive minerals, as well as Vit D3, MK7 and trace minerals like phosphorus, manganese, etc.

 

[Judee]

I had a co-worker friend would was older than me. She would walk outside year round no matter what the weather. She walked for at least 2 miles everyday faithfully for years. The only thing that would hinder her is if the sidewalks weren't safe because snow and ice hadn't been cleaned away enough. However, as soon as it was she was right back to her walking.

Her doctor switched her to the once yearly dose of one of those bisphosphanate meds. She went for the first IV treatment. After that she could barely walk. It was a drastic change and very disheartening to see.

Nothing else had changed in her meds so I'm pretty sure that's what did it.

Unfortunately, I don't believe she ever got back to being able to walk like that again. I know she would walk in the hallway at her apartment building with a walker but that was about it.

Anyway, just be careful.

 

[lenora]

Thanks for the replies (and I would welcome more, if you have anything).

@Shanti1. Thanks for your reply. I do hope your husband has remained at least stable in all areas, not just his osteopororsis.

Yes, a side-effect of cancer treatments is often osteoporosis, as well as age in males. Those over age 70 are at the same risks as women.

As stated, I've had this for many years....probably a good part of my life. However, I was also born with congenital deformities and even though I did walk to a school miles away (yes, these stories are true), I was still a candidate for what we now know as early-onset osteoporosis. I've been a walker my entire life; just not a person who didn't when I could do such things. Also used to be a bicycle rider. My husband is the same.

@Judee.....Yes, I personally know two people who fit into the description you gave of your friend. It's alarming and I'm really in a quandary about what to do. So my Dr. tells me that fosamax isn't working for me...and yes, prolia does work in a different manner. So that's why I'm really worried about changing. Plus the great unknown: Will anything ever work?

Age confers many physical ills upon us, or at least some of us. On top of everything, we're supposed to take bone building vitamins....doctors are more and more combining both types of healing in their treatments. My neurologist is my general "go to" Dr. I've known him for many years and he gives good, practical advice, (His patients have multiple diseases requiring "out of the box" thinking). I have been assured that none of the other doctor's patients have suffered side-effects. If that is so, why have I heard of 3 direct cases?

Shanti 1.....Yes, my friends did receive prolia. It would seem that Medicare rules and contracts (?) where and how the prolia is given. Neither of my friends had ever heard of FM, but I recognized the symptoms immediately. I've had 11 falls altogether (that I can remember) and now have 2 different types of epilepsy, and I'm on meds for both of them. Point being that I never broke anything (one vertebra) in any of the other falls, so fosamax must be working to a certain degree. The first 10 falls were straight back onto tile in the bathroom, with concrete underneath (no basements where we live). These were in a cluster before the epilepsy was discovered about 2 years ago.

The last time I fell sideway and that's when the fractures appeared. Terrible pain for the first 2-3 mos., and then as healing took place, the pain disappeared or at least lessened considerably. I'm just fortunate I didn't break my hip.

I appreciate that you took the time to write and would be grateful for input from other people. So many problems and questions. Life is forever changing, isn't it? Thanks again. Best of health. Yours, Lenora

 

[vision blue]

The thing about Prolia is that theres no exit strategy. That is, if youre on it, count on being on it for life Apparently, if one discontinues it - even after just one injection - bone loss skyrockets as a rebound effect. Ive heard some claim that docs did not know this when they gsve it to so many patients. Hard to believe the manufactureres didnt onow this ahead of time

If you have alot of drug sensitivities, it could be a risky choice because of what would happen if you were unable to take it again

I had a friend who was on it for years and started getting full body rashes with eqch inhe tion. She just takes benadryl since theres no safe way to exit. But she does not have a mast cell disorder.

@Judee what a sad horrible occurrence and makes me hate the med system even more. Do you know which bisphosphanate that was?

 

[Judee]

Do you know which bisphosphanate that was?

No, I'm sorry. I can't remember the name she told me.

I tried to look it up last night before posting but nothing sounded familiar. It may have been the Reclast but I'm not sure. I want to say Boniva but it looks like that is given more often and I know that she told me the one she was switched to was only given once a year.

Edit: Yikes, I just tried to look it up again to see if Boniva is ever given once a year. The reviews on drugs.com are not good.

@lenora, I didn't look up Prolia there but you could if you want to. Also askapatient.com is another site that is just patient reviews of drugs.

 

[vision blue]

@Judee thanks fir posting the ask patient site. Although i go to the other drug site for reviews i didnt know about this one and its even better!

Im having a blast reading comments on gabapentin and has also helped figure out whats going on

 

[Shanti1]

Thanks for your reply. I do hope your husband has remained at least stable in all areas, not just his osteopororsis.

Thanks, Lenora, he was given 2.5 years and is still in remission (with meds) 5.5 years later, something I am thankful for every day.

Yes, my friends did receive prolia. It would seem that Medicare rules and contracts (?) where and how the prolia is given. Neither of my friends had ever heard of FM, but I recognized the symptoms immediately.

I can't blame you for being hesitant to try Prolia. Joint, muscle pain, and fatigue are common side effects, and since it is a six-month injection, it's not like an oral medication that you can just discontinue. It looks like Prolia is better than Bisphosphonates at building bone density, but it hasn't been shown to be more effective at reducing fractures, at least not yet (ref, ref, ref)

https://www.drugs.com/sfx/prolia-side-effects.html
Very common (10% or more): Back pain (35%), arthralgia (14%), pain in extremity (12%)
Very common (10% or more): Asthenia (45%), fatigue (45%)

@vision blue brings up a really important point about rebound bone loss. This rebound effect can be mitigated partially or completely by switching to a bisphosphonate when/if prolia is discontinued (ref). If you try Prolia and need to stop, it seems you would want a solid discontinuation plan in place.

Alternatively, I wonder if your doc would be open to trying adding calcitonin to the bisphosphonate. Here is a study showing that the combo works better than a bisphosphonate alone and, as a bonus, calcitonin can help lessen fracture pain: https://pubmed.ncbi.nlm.nih.gov/28108224/
If you aren't on warfarin, you could also try high dose Vitamin K2, as menoquinone-4(45mg), (ref, ref, ref, ref) combined with the bisphosphonate and calcitonin.

If your doc is on board with something like the above, you could get a baseline reading of bone turnover markers like CTX and DPD and then measure them every few months to evaluate whether the therapy is going in the right direction. DEXA scans are usually only repeated every 2 years, so bone turnover markers can be useful in the interim. If the bone turnover markers aren't favorable, you could revisit denosumab.

BTW, Prolia is only approved for injection and its effects and side effects have not been studied for IV administration:

Denosumab -NIH
The administration of denosumab should be via subcutaneous injection only and should not be administered intravenously or intramuscularly.

See also: Prescribing information-FDA

The last time I fell sideway and that's when the fractures appeared. Terrible pain for the first 2-3 mos., and then as healing took place, the pain disappeared or at least lessened considerably. I'm just fortunate I didn't break my hip.

Sorry you had to go through that along with everything else already on your plate, honestly, I can't imagine.

 

[kangaSue]

I can't tolerate the oral meds due to having chronic gastroparesis so I have Aclasta infusions (same as Reclast - zoledronic acid).
Was told to likely expect side effects with the first infusion (flu-like symptoms, maybe with 'bone ache'), and possibly with the second one, but haven't had any issues at all with the infusions. I do have autonomic neuropathy, but it doesn't involve any element of painful neuropathy and not affected by the infusions either.

 

[lenora]

Thanks all of you kind people for your replies: @Shanti 1, @Judee, @vision blue and @kangaSue....All were immensely helpful and so many were full of detail.

This really is a confusing problem and it's made worse by the fact that I've been on Fosamax since it was discovered. Genetically I'm just not very well put together, but there have been so many wonderful, helpful people along the way. I definitely count your answers among them and I'm grateful for such caring advice.

I have had a heart attack, have multiple shunts and am on blood thinners. It all gets so confusing and difficult and yes, I'm certainly not the only person affected by these matters.

My father died at age 40 because of a heart attack.....so please know that we have been the beneficiaries of so much medical knowledge gained at the expense of meds, doctors learning about what the best course of action is and of course, the patient as the test subject. I'm old now (age 75), so am fully aware that problems can exist. Still......it does help to receive such great info & experience. Yours, Lenora.

 

[Judee]

I know I already pm'd you about this once but maybe just until you decide about the medication, look into K2 again in the form of bean natto.

It's supposed to be good for bones and for heart health and it's a food (although definitely an acquired taste food) so it shouldn't come with a lot of possible negative side effects (other than the taste) like medications do.

https://www.lifehack.org/326344/11-reasons-eat-natto-japanese-soybeans

I made it with chickpeas and although I don't think mine was fully fermented...it had the strings...it just didn't smell as stinky as I was expecting. Anyway, I got used to the taste and actually started to crave it. It's kinda like a sharp cheese. Plus, it really helps my mouth feel moistened. I think that's the bacteria.

Disappointingly, I have made it since but my batches failed so even though I have a soy sensitivity I've been debating buying the pre-made kind from Amazon.

Anyway, just a thought. Hope you can figure all this out @lenora. I know it's hard to make decisions about medications especially with ME and additional health issues.

We just never know how we'll respond to something.

 

[YippeeKi YOW !!]

I know I already pm'd you about this once but maybe just until you decide about the medication, look into K2 again in the form of bean natto.

I second the need for MK-7 for bones, among other things.

D3 activates calcium, and calcium is sort of like a 4 yr old toddler .... places to go, things to do, people to see, but no real idea of where, what or who. Even without D3 supplementation, the calcium you take in thru diet needs direction, too.

MK-7 escorts the calcium politely to where it's needed, like bones and teeth, instead of where it not only isn't but will do damage, like arteries, blood vessels, soft tissues. cartilage, etc.

So either by eating natto (def an acquired taste, but one worth acquiring .... I keep meaning to give it another chance) or by taking it in supplement form (I use NOW Foods MK-7), it's an important part of both bone health and avoiding arteriosclerosis ....

We just never know how we'll respond to something.

Ain't it the truth ...

 

[lenora]

You're so kind to go to so much trouble @Judee, and you know that I appreciate your efforts

Your site also helped and right or wrong, I'm thinking that I should just stay with the Fosamax at the present time. I'll be in touch with you. Take care of yourself....and try another batch of beans. Yours, Lenora

 

[kangaSue]

@lenora Here's an interesting article to bear in mind if you happen to decide to try the Aclasta/Reclast infusion route;
https://pubmed.ncbi.nlm.nih.gov/22350110/

As it happens, my vitamin D level was deemed too low at first to start on my first Aclasta infusion so I had a couple of megadoses of cholecalciferol (600,000 iu each) 3 months apart - the second one about 4 weeks before the first infusion - so maybe that's why I had no pain issues from the infusion.

 

[lenora]

Thanks, @kangaSue. Goodness, but these decisions are very hard to make. My 'D' levels are fine, right in the middle range....and I don't know if we'll have a magical answer for this in the near future. However, fosamax was the first drug used for osteoporosis here....(I've been on it for at least 25 yrs.) and there have been what, 3-4 drugs that are new since that time.

Interestingly enough, the side effects for all seem to be about the same. I'm sure they affect individuals in different ways, but I'm very glad to hear that you didn't have pain or increased pain....and hope with all my heart that it will keep you free from osteoporosis.

Today was Mother's Day in the U.S. Father's Day is celebrated in June. I'm sure you celebrate these holidays and is around the time of Mothering Sunday (is it still called that?) in the U.K ?. I can't even remember when it's celebrated...March, perhaps. I expect you have such a day also. Thanks again! Yours, Lenora.

 

[kangaSue]

My 'D' levels are fine, right in the middle range....and I don't know if we'll have a magical answer for this in the near future.

Ahh, ok. My vit D level had been deficient for about 3 years and I couldn't get it to shift more than a handful of points (and stay up) even with regular megadose cholecalciferol (600,000 iu) injections and regular sun exposure. After the two megadose jabs close together and then starting on the Aclasta infusions, I am holding on to vit D now with a cholecalciferol (100,000 iu) injection every 3 months or so.

Today was Mother's Day in the U.S.

I'm in Australia, Mother's Day here was a couple of days back, Sunday.

 

[LaurelW]

I got osteoporosis around age 60 after having ME for 20 years and a less-than-active lifestyle. I tried Fosamax, but it gave me horrendous heartburn. When my osteoporosis kept getting worse, I considered taking Reclast and read a lot about it, but the possibility of having worse fibro pain for six months put the damper on that. Plus osteonecrosis? No thank you. Meanwhile, I went to my GP to talk about it, and there happened to be a pharmacy professor from the local medical school there that day. She said that if I were to go back on hormones (I had been off for about three years) it would give me as much benefit as any drugs with less side effects. (FYI, I never used Premarin or Progestin--too much cancer risk. I got bioidentical hormones from a compounding pharmacy). My next bone density scan two years later actually showed improvement. I'm about to get another one next month, so will see. I also take a formula called Garden of Life Grow Bone System supplements (they are vegan). The only downside to the bioidentical hormones is that they are expensive. Insurance doesn't normally pay for them.
I actually tripped over a curb last week and smacked my palms and left knee. Nothing broken, thank heavens.

 

[lenora]

Yes, hormones can protect us, but having them prescribed is against medical rules, even at my age (75).

In the beginning, fosamax was taken on an empty stomach 45 minutes before food or drink. It did indeed contribute to heartburn and other problems. A very few years later, it was found that if you stand (take a shower, wash you hair, that type of thing) then this side-effect can be avoided. Even sitting can work.

I stopped fosamax for about 2-3 years after having been on it for approx. 25 yrs. (or whenever it came out). It has a long half life and I was also afraid of the side effects. All have them, but the effect we can have is an important broken bone. (Say a hip that doesn't heal after surgery). I've had a few fractures, but remember that I've had osteoporosis since my early 40's. I have a good diet, no one has answers. I also take K2 with my bone building minerals.

I agree that bioidentical formulas were introduced, but many of those people were also subject to bone fractures in later life. Men should also be aware that after age 70, they're as probable to develop osteoporosis as women. Ask your doctor what should be done .e.g. Meds and other treatments can also affect this outcome (some cancer treatments cause osteoporosis in both men and women. In the early days we weren't aware of bioidentical hormones. I would have tried them first....however!

I'm now suffering from 5 pelvic fractures and one in a vertebra that has fractured before. No surgery was required, thank goodness. My neurologist is of the opinion that I should just live with it....as he has seen too many patients not left in good condition b/c of surgery. Mine is a congenital condition, but neighbors in their 50's are being treated for broken bones, my cleaning women both fractured their wrist and one her elbow recently, and another recovered very well from hip and knee replacements. (She's 80 and has no osteoporosis). I have lost 3" in height, but do want to avoid more surgery.

I've had no teeth or jaw problems....well abcesses in some teeth, but they weren't caused by fosamax. I'm back on it now. My GP wants me to have the prolia injections that last 6 mos. I've know too many people who have had bad reactions to these injections....they work in a different manner than fosamax. Thigh bones can fracture with all of the osteoporosis drugs...why? No real answer, this is a possibility.

Let me say this, please: I fell straight back approx. 10 times over the past two years. Tile floor with concrete underneath. Nothing obvious occurred. I also have two types of epilepsy, so it's possible that an attack caused my latest fall. As you age, you don't even expect answers. We just do our best. Yours, Lenora.