1. Community
  2. Bones, joints and muscles
  3. Polymyalgia Rheumatica and GCA

Prolia injections - osteoporosis

Posted , 18 users are following.

FlipDover_Aust
FlipDover_Aust

I was just at the Dr to discuss my latest CRP results (better than expected!) and she asked me if I'd had my bi-annual Prolia injection (I have). when I got back to work I thought I'd do a bit of digging and I found a couple of things that make me wonder if Prolia may have contributed to my PMR developing. Just my imagination but is there a coincidence? Anyone else had Prolia injections?

Check this out:

Prolia was approved in 2010 for the treatment of osteoporosis and for preventing new bone fractures especially in postmenopausal women. This new drug modifies the regulatory control of the immune system over bone remodeling. Its cutting-edge design is matched by the ease of its twice-a-year administration. But Prolia is far from the wonder drug it is being promoted as. By modifying the immune system, it impairs general immune response. And curiously, Prolia can kill off the bones of the jaw and cause hip bone fractures.......

The lack of long-term safety studies for Prolia makes it highly dangerous. Reading the product’s safety information on the manufacturer’s website is particularly depressing. Amgen lists a number of horrifying adverse effects of Prolia.

One can only wonder what other side effects are there if the manufacturer admits to such profound damages.

The severity of the identified side effects of this drug makes it even worse than bisphosphonates. And only time will tell what new side effects will emerge in a decade when independent safety studies are published.

Most of the side effects of Prolia are caused by its negative influence on bone remodeling and its interference with the roles of RANKL in the immune system.

RANKL, for example, is required by T helper cells. By inhibiting such immune cells, Prolia increases the chances of infections, hypersensitivity reactions and autoimmune diseases.

Even the FDA raised concerns about the effect of Prolia on important immune cells and cytokines. But then, the regulatory body approved the drug a year later.

While the disruption of the immune system is terrible, the effect of Prolia on bone remodeling is simply unforgivable. Even Amgen admits on the product page that Prolia can cause thigh bone fractures and osteonecrosis of the jaw bone.

7 likes, 44 replies

44 Replies

Next
  • tina-uk_cwall
    tina-uk_cwall FlipDover_Aust

    Posted

    Morning flipdover, I read with amazement the amount of auto immune conditions there are out there. Some have been around or at least recognised for many years, PMR, Ms, whilst others are are only just being given names although they could or probably have been around for years too.

    i definitely believe, although I have no evidence, that our environment, lifestyles etc play apart in whether we develop these conditions. I think that our gene makeup plays a part in all of this too.

    i read an article about the children of a Manchester (I think it was Manchester) slum area in the 1940's that used to play with all the asbestos dust that would settle in the corners of their streets from the asbestos works next door. I couldn't believe the photos, the children played asbestos balls with it very much like children play snow balls. Now these children were breathing in unbelievable amounts of this most dangerous substance yet only some of the children or indeed occupants of the surrounding area went on to develop asbestosis? Why? Could it all be down to their genes? Some peoples body's are able to accept degrees of substances yet others can't? I just don't know. But take preds, luckily for me I have suffered few side effects (what it's doing to my insides Lord alone only knows) whilst others of you suffer terribly from the side effects of the drug.

    i also think that here must be lots of drugs that interfere with the workings of our immune system and if we as individuals have the propensity to be affected by that, then a chain of complications then sets in that we may not suffer the consequences of for many years to come, maybe because our bodies fight it off, and fight it off until it cannot fight it any more then bang!!!

    now you know of this information what do you think you'll do now regarding these injections/drug? Regards, christina 

  • arwen1972
    arwen1972 FlipDover_Aust

    Posted

    *drops jaw* Oh my goodness! Will you continue with the drug now?
    • FlipDover_Aust
      FlipDover_Aust arwen1972

      Posted

      Absolutely not! I'll also take my research (once complete!) to my Dr - she's pretty open to discussion.
  • rapha
    rapha FlipDover_Aust

    Posted

    That's one I will NEVER take thanks for the info....came off alendronic acid today after a discussion with my doctor yesterday... been taking it for 6 months!  I went to him armed with info about the drug which I got off this site I told him everything about it and he just said "Stop taking it"!  I had to bite my tongue from saying "Then why the dickens did you put me on it in the first place"!  He also agreed to book me in for my DEXA scan.
  • bronwyn97278
    bronwyn97278 FlipDover_Aust

    Posted

    thanks flipdover; unless people like you let us others know re these issues, we all blindly follow our docs and their prescriptions.....I also started a drug a few weeks ago, that my Rhuemy suggested for my Fibro,,,,and, well, (nearly used an unacceptable term.... not the f word but something still not good)......I have stopped taking it too, as it made me 10 times worse...in fact I think it did the opposite to what it was supposed to do (was bursting into tears for NO reason) Cymbalta.......just goes to show......Bron
    • judytal
      judytal bronwyn97278

      Posted

      mornin,

        my Dr just offered me Cymbalta ,   She said she has given it to her other PT's who have PMR for energy !!  I said NO ... Not another pill!

       

    • Oregonjohn-UK
      Oregonjohn-UK judytal

      Posted

      I quote from my wifes BNF.

      'The British Medicines Consortium has advised (Sept 2006) that duloxetine (Cymbalta) should be restricted for use by specialist when other treatments for diabetic peripheral neuropathic pain are unsuitable or inadequate'

    • judytal
      judytal Oregonjohn-UK

      Posted

      Had a friend who is diabetic and was given Cymbalta for neuropathy.  She stopped taking it... Her reason " dry mouth". 
  • Oregonjohn-UK
    Oregonjohn-UK FlipDover_Aust

    Posted

    Trade name is Prolia common name Denosumab - info at BNF page 498.

    From NICE - NICE recommends denosumab as a possible treatment for preventing bone fractures in some postmenopausal women with osteoporosis (see below).

    Who can have denosumab?

    If you have not had a bone fracture caused by osteoporosis, you should be able to have denosumab if:

    your doctor thinks you are at risk of having a fracture (see below) and

    you can’t take alendronate and either risedronate or etidronate.

    If you have already had a fracture, you should be able to have denosumab if you can’t take alendronate and either risedronate or etidronate.

    You can ask your doctor to explain if denosumab is appropriate for you.

    Who is at risk?

    To see if you are at risk of fracture, your doctor takes into account your age, your bone density, whether your parents had hip fractures, whether you have rheumatoid arthritis and how much alcohol you drink a day. You might need to have a bone scan (known as DXA) to measure your bone density.  

    Why has NICE said this?NICE looks at how well treatments work, and also at how well they work in relation to how much they cost the NHS. NICE recommended denosumab for certain

    • eddylynn36538
      eddylynn36538 Oregonjohn-UK

      Posted

      I have had PMR for 10 years and been on prednisone at different amounts throughout that time...often able to enjoy a normal lifestyle but seldom below 10mg.  I saw a PMR specialist (26 years experience) this month and after a bone density scan that said I did not have osteoporosis put me on prolia "because of high risk due to age and long term use of prednisone).  Previous to that visit I had 3 bone density scans over the 10 years at a different clinic in a different city  that indicated I did have osteoporosis and was on two different meds during that time.   I was on 20mg of prednisone and he is taking me down very, very slowly...7 weeks to get to 17.5 and another 7 weeks to get to 15.  Because of the side effects of coming off prednisone and also fibraymyalgia I cannot point to anything as a sideeffect of prolia.
  • EileenH
    EileenH FlipDover_Aust

    Posted

    All the "bone protection" medications have similar downsides - and Prolia/denosumab is classed as a bisphosphonate like alendronic acid. They all can cause these thigh bone fractures and osteonecrosis of the jaw after extended use.

    In the UK Prolia is at the end of the list - because it is very expensive and you start with No1, alendronic acid, which is cheapest and as you fail each of them for whatever reason you move up to the next.

    The marketing for AA was outstanding - bisphosphonates had been used in Pagets disease for 40 odd years and AA was the first to be launched as Fosomax for general use: "Never have a patient dying of a hip fracture again" sort of message. Doctors (being rather naive people) swallowed it hook, line and sinker and the company made a fortune on the back of it. But it hadn't been used for mass numbers before and that is when the real rate of side effects is found. 

    This is a bit OTT - just like the marketing - but there should be concerns about the blanket use of these things "just in case" which is what happens now. That's why I say "Dexascan first", then you can discuss the situation.

    I'm not the only person to have been on pred for a few years and have no loss of bone density. There is no REAL proof that taking this stuff (any of it) prevents hip fractures - there is no REAL correlation between low bone density and fractures. People with normal bone density have fractures, people with low density don't have fractures.

    However - Nefret on here has been on Prolia for a couple of years and had no problems at all. Some people have been on AA with no problems. It's like everything else - maybe it was the final straw that broke the camel's back.

    As for using Cymbalta for "energy" - well that's a new one on me!!!!!

    • Juno-Irl-Dub
      Juno-Irl-Dub EileenH

      Posted

      Hi Eileen, I'm interested in your comment that "there is no real correlation between low bone density and fractures". Before I started treatment my FRAX assesment showed that I had a ' 52% chance of a major osteoporotic fracture in the next 10 years' - which freaked me out more than a little. I am aware that people with normal bone density fracture all the tjme and others with low bone density can fall and have no problems but. . .but ... with my results (spinal very low bone density)  I was wondering just what was holding me upright at all !! And for how long?   So then came the evaluation of research papers (not funded by drug companies), the sleepless nights - and finally the jump into the unknown . . .  Kind wishes.
  • Juno-Irl-Dub
    Juno-Irl-Dub FlipDover_Aust

    Posted

    Hi flipdover, Yes Prolia does affect the immune system but so do many other meds. that are commonly used (MTX for arthritis, Pred.,  asthma inhalers, chemotherapy etc.). My Rheumatologist did not advise Prolia precisely because of this effect. But then she put me on another agent that has even more serious possible side-effects than this - but for a short period. . .  It's all about risk-balancing. We all know people who won't fly when they hear of planes crashing but statistically flying is hugely more safe than the drive to the airport - which we don't worry about at all.. Still planes DO crash, albeit rarely. It's the same with various treatments - some have nasty (hopefully rare) side-effects but your bone disease, untreated, also does. It's all about risk. SO - read up about the various drugs, talk openly with your Rheumatologist, spend time thinking, decide what you feel is best for yourself, and then plough on and hope that, if you do experience any nasty side-effects, - that they are reversible. Best wishes.

     

    • Juno-Irl-Dub
      Juno-Irl-Dub

      Posted

      I am presuming that you have OP diagnosed by scan . . .
    • EileenH
      EileenH Juno-Irl-Dub

      Posted

      I'm sure she'll reply or you've seen her post - no, no OP.

      That is the basis of most of our complaints. Many GPs and some rheumies hand out bisphosphonates alongside your first prescription of pred or very soon after. No fractures, no dexascan showing reduced bone density, they have been told by the drug reps it will prevent osteoporosis developing and pred can accelerate the development of OP. And it is assumed that anyone over about 60 has osteoporosis - it seems they can see through skin and bone! Some doctors get very aggressive when patients disagree and ask for evidence of their need. That is what we on the support groups say: IF you need them, fine, it is probably  worth the risks and that is what use of any drug involves, the benefits must outweigh the risks. However - indiscriminate use "just in case" is not acceptable and now the FDA and others are beginning to catch up on the bad aspects but many doctors have not yet got the idea. 

       

    • lizthib
      lizthib Juno-Irl-Dub

      Posted

      had my 1st prolia shot 5 weeks ago. before that, i was feeling great, walking with no shortness of breath, no neuropathy, no headaches, and just feeling excellent overall.  this was after a 4 year struggle with osteoporosis (7 fractured vertebrae), severe anemia (hemoglobin down in the 4's many times and usually no higher than 7-8 even after blood transfusions), stable fatty liver cirrohsis and dormant sarcoidosis.  now, i feel like crap everyday, both bottom front of feet have neuropathy, my ast and alp has shot up to 270's. can't control my glucose numbers (a1c went from 6.9 to 8.9) and can hardly take 4 steps without being short of breath with a crushing feeling in my chest. everything points to taking the prolia. i don't even know where to turn now. my bone density scan showed marked improvement before I got the prolia, so i don't think it was warranted. i almosr refused it since i had read about the side effects, but the doctor talked me into it and now my medical situations are way more grave than anything i read. i would like answers to all of these conditions and definitely will not take any more prolia, period. i pray that as it leaves my body in 6 months that some of my damage will be reversible or i can look to a very shortened life span.
    • Juno-Irl-Dub
      Juno-Irl-Dub lizthib

      Posted

      lizthib, very sorry to hear of your problems with Prolia. I kow all meds. can have side-effects but yours seem particularly awful. As Prolia and Forteo are used for those with severe OP, I presume your doctor put you on it becuse of your 7 fractures ( did you mention your t-score in the past?).

      Re. what you should do - I'd contact my rheumatologist or doc. straight away, tell him about the side-effects and question him about how long you can expect to have these to continue. And tell him your decision not to continue taking it. Like yourself,  I've read also that this med. clears the body in 6 months so hopefully you'll start to  feel a lot better in the near future.  

      Kind thoughts,  J

       

    • eddylynn36538
      eddylynn36538 lizthib

      Posted

      Hello Liz    I have had pmr for 11 years that was controlled quite well until last summer when I had a flair. My Internist upped my pred to 20 mg to decrease by 5 mg after 4 weeks, then a further drop of 5 to 10.  A month later as was seeing my physician for something else and she decided to send me out of town to a specialist about osteoporosis. It turned out this specialist is also a specialist in PMR and has been for 26 years.   I had the bone density test the same day and he advised me to go on Prolia.  Mainly because I hadn't tolerated other drugs for this condition and because of the long term use of prednisone I am at high risk.  I do not have osteoporosis!!!!  I have had some very bad falls off steps etc and have never broken a bone.   He also revised my withdrawal schedule of prednisone to very slow (7 weeks to reduce 2.5) as opposed to 4 my internist suggested.  So I got the prolia (here it has to be ordered in, picked up at pharmacy and delivered to doctors office for a nurse to inject.  That was 7 months ago and I can count the days I have felt well.   Extreme fatigue, can barely climb stairs, everyday chores are very difficult.  Very short of breath and after many doctor visits and x-rays, blood work, etc. etc. nothing was found.  It finally dawned on me to check the prolia websight as I had just ordered the next shot of prolia.

      Not wanting to wait another 6 months I asked the pharmacist if i needed to pay for the Prolia ($400) and he said not if I didn't take it out of pharmacy, so I quit.  My doctor didn't say much except the bad news is that is stays in your system.  I have an appointment with my rheumyat the end of month, so see what I get told then.  I also have fibromyalgia but I am not in pain anywhere just this d----fatigue!!.,

      You have so many other problems to deal with, you shouldn't have been stuck with this one too.   So sorry.

    • Juno-Irl-Dub
      Juno-Irl-Dub eddylynn36538

      Posted

      HI, Why on earth did your specialist put you on Prolia or any OP drug if you don't have OP? Did he tell you your Dexa result?  Your after- Prolia injection symptoms sound just like lizthib's. Like yourself, I have PMR and am taking steroids for nearly 3 years now and this was why I had a bone scan and found out that I had severe OP in the spine but no fractures.  The 2 drug possibilities were Prolia and Forteo and the latter was chosen by my specialist. Forteo is ok for me but some find they have to stop it because of side-effects. I have 2 close friends who were prescribed Prolia for over 2 years now and have no problems so far. Re. it "staying in your system" I have certainly read that it's cleared from your body within 6 months as opposed to the bisphosphonates which can last for a decade. . . I really hope your problems improve also.  

      Kind regards, J

    • FlipDover_Aust
      FlipDover_Aust lizthib

      Posted

      oh dear... and this is why I'm so against this drug. I believe it stays in the system for 6 to 12 months.

      I didn't need it either, my Dexa scan, done 3 years AFTER my GP insisted I have the shots, showed that my bone density is well above average. So far in fact that the Drs couldn't believe it. At 52 I have the bones of a 20 year old! good news indeed. ! 

      Surprisingly, I don't have the shots any more!

    • eddylynn36538
      eddylynn36538 Juno-Irl-Dub

      Posted

      Bone scan showed negative 0.6 spine and negative o.7 hipbecause of 11 years of pred says I am at extreme risk. Had to make the decisions to try and get better or risk fracture. I hope I made right decision as not better yet. But some days there's a glimmer of hope. I also have a friend who went thru the trials for this drug with no problems. Guess we're all different.
    • EileenH
      EileenH eddylynn36538

      Posted

      Off the top of my head, those figures are osteopenia, not osteoporosis, and if you were not on pred would not be indicative of requiring treatment. Mine are not as good as that, no-one has suggested any drugs for me here in Italy. In the UK I was handed alendronic acid along with pred - I took 4 tablets and stopped after discussion with one of the other GPs in the practice.

      You have those readings after 11 years of pred - the received wisdom is tha the majority of bone density loss is in the first 6 months or less of pred usage, probably because the dose is at its highest. There is considerable dispute about the link between low bone density and fracture risk - people with normal bone density have fractures, people with low bone density often don't. There are a load of other measures to take to reduce the risk of falling - which is the greatest risk factor. Now it IS possible that simply being on pred is a risk factor - for separate reasons, but there is no real evidence I know of that increasing your bone density would change that. 

      I might consider something if my bone density fell - but my biggest reservation about any of the stuff that is given annually or 6-monthly is that its half life must be such that it has an effect on the body for longer if there is a problem. So far, after 4 years on pred there was no change in bone density, I'm sticking with that.

      I do hope it works its way out of your system 

Back to top
Next

Report or request deletion

Thanks for your help!

We want the community to be a useful resource for our users but it is important to remember that the community are not moderated or reviewed by doctors and so you should not rely on opinions or advice given by other users in respect of any healthcare matters. Always speak to your doctor before acting and in cases of emergency seek appropriate medical assistance immediately. Use of the community is subject to our Terms of Use and Privacy Policy and steps will be taken to remove posts identified as being in breach of those terms.