Prolia Denounced -

[Ruadh]

Denosumab and osteoporosis, more doubts than evidence

Independent experts in the pharmaceutical industry denounce the improbable effectiveness and excessive risks of denosumab. By Jérôme Vincent

Modified 08/01/2019 at 16:47 - Published on 07/10/2015 at 16:23 | Point

prescrire.org/Fr/202/1830/5...

• Denosumab dosed at 60 mg (Prolia °) is effective

very modest in preventing fractures in

osteoporosis and has no demonstrated clinical efficacy

in “bone loss” during cancer of

prostate. It exposes to disproportionate side effects

: back pain, muscle pain

and bone, multiple fractures after stopping,

osteonecrosis, immune disturbances

and serious infections (including endocarditis) related

immunosuppressive effects of this antibody

monoclonal (n ° 329 p. 168-172; n ° 362 p. 901;

No. 385 p. 806; n ° 418 p. 584 and p. 591-592). In

osteoporosis, when non-drug means

and the intake of calcium and vitamin D are effective

insufficient, alendronic acid (Fosamax ° or

other), or even raloxifene (Evista ° or other) as an alternative,

have a better risk-benefit balance,

despite the significant limitations of these drugs.

In “bone loss”, there is no known despite the significant limitations of these drugs.

In “bone loss”, no satisfactory drug is known (c) .-

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Denosumab 60 mg (Prolia °) - a medicine to rule out care

To help choose quality care, and avoid disproportionate damage for patients, we updated at the end of 2019 the list of drugs that Prescrire advises to rule out for better care.

Denosumab 60 mg (Prolia °) - a medicine to rule out care

The denosumab dosed at 60 mg (Prolia °)has a very modest effectiveness in preventing fractures in osteoporosis and has no proven clinical efficacy in "bone loss" during prostate cancer. It causes disproportionate adverse effects: back pain, muscle and bone, multiple fractures after stopping, osteonecrosis, immune disorders and serious infections (including endocarditis) related to the immunosuppressive effects of this monoclonal antibody. In osteoporosis, when the non-medicinal means and calcium and vitamin D intake are of insufficient efficiency, alendronic acid (Fosamax ° or other), or even raloxifene (Evista ° or other) as an alternative, have a better benefit-risk balance, despite the significant limitations of these drugs. In the "

Note: Another specialty based on denosumab dosed at 120 mg, Xgeva °, is allowed especially in patients who have bone metastases of a solid tumor. In this situation, denosumab is only one option among others, without its benefit-risk balance being clearly unfavorable (No. 341 pp. 174-176).

Documentary resources Prescribe

"Denosumab-Prolia °: poor efficiency in terms of fractures, far too much risk" Rev Prescrire 2011; 31 (329): 168-172. ( pdf, subscribers only )

"Prolia": the doubt benefits the firm "Rev Prescrire 2013; 33 (362): 901. ( pdf, subscribers only )

"Denosumab-Prolia" Male osteoporosis: to be excluded in men as well as women "Rev Prescrire 2015; 35 (385): 806. ( pdf, subscribers only )

"Denosumab: multiple vertebral fractures at rest" Rev Prescrire 2018; 38 (418): 584. ( pdf, subscribers only )

"Denosumab: immune disorders" Rev Prescrire 2018; 38 (418): 591-592. ( pdf, subscribers only )

All of these syntheses are available in the Prescrire Application. > Learn more

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Prescrire's assessment of the benefit-risk balance of a drug in a given situation is based on a rigorous procedure > Learn more

Download the full text of the 2020 Review of Medicines to be Deregulated

Download

FREE "To better treat, medicines to rule out: 2020 assessment" Rev Prescrire 2019; 39 (434): 931-942. (pdf, free access)

"...despite the significant limitations of these drugs.

In “bone loss”, no satisfactory drug is known (c)" .-

[HeronNS]

Perhaps you've seen on bone health sites the disturbing number of people who have taken Prolia and now deeply regret having done so.

[Ruadh in reply to HeronNS]

Morning Heron - No. Am not subscribed to that site. But knew from reports that have been coming in for a while now, how dangerous Prolia was. So was glad to see this from Prescrire. So sad for all the people who have been persuaded to take and, who have come a cropper from taking, Prolia.

I have taken several opportunities to post on the down sides of Prolia - and what is so daft, is that there are excellent alternatives that one can take to reverse osteoporosis ! We do not have to lay ourselves open to the corruption and greed of pharma nor to the false 'health' trails laid down by medical guidelines.

[PMRpro Ambassador]

I'm not sure it is entirely correct to describe Prolia as "dangerous". It does improve bone density quickly - so for someone with severe osteoporosis it has a role. It is when you stop Prolia that the problems arise - so a change in therapy after a couple of years is required to maintain the improved bone density. In some ways it is no different to the other options for increasing low bone density - they all have problems in the long run.

[Ruadh in reply to PMRpro]

Prolia is being 'pushed' for severe osteoporosis, but frankly, it sure comes with a very nasty downside - and to prescribe it for osteopenia / low grade osteoporosis ! Not the best idea out there. The BIS drugs are not that efficacious, as they prevent bone turnover / replenishment, so bones end up up getting harder and harder and end up like dried out tree branches - prone to breakage, exactly as has been found. As for possible problems of osteonecrosis of the jaw...dentist are not too happy to treat patients on any of the BIS drugs.

As for Prolia - Ho-Hum.

[PMRpro Ambassador in reply to Ruadh]

In the UK at least it is NOT being "pushed" as you put it, it is unlikely to be used until after other options have been looked at since it is more expensive. I totally agree with you that none of them should be used for osteopenia - and I say that on a regular basis. But sometimes there are reasons for using drugs that have considerable longer term adverse effects and where the use must be balanced against those risks.

[Jimmy2008]

Hi there Ruadh. I have recently been prescribed Prolia and it is currently sitting in the pharmacy’s fridge awaiting my go ahead. I am now feeling discouraged and confused about beginning this medication. May I please ask for some guidance from the experts on this forum?

[PMRpro Ambassador in reply to Jimmy2008]

You have an osteoporosis charity in Australia with a helpline. If you were in the UK I'd suggest you ring their charity helpline and ask their opinion.

osteoporosis.org.au/treatme...

Your specialist is also an appropriate person to discuss it with.

We are all patients here - no-one is an expert in that field. However, a lot depends on the results of your dexascan - is your bone density of a level where denosumab/Prolia is really required?

[Jimmy2008 in reply to PMRpro]

Thank you PMRpro for your response. I am borderline osteoporosis/osteopenia, according to results from a recent dexascan. Prolia Perhaps not really required as yet. I feel that I am pumping my body with so many alternative meds and wonder if continuing to take calcium, vitamin d and K2 is an alternative to six monthly injections of prolia, now knowing that once I begin, I cannot stop. I have an appointment with my GP on Tuesday and will discuss pros and cons. The article was helpful. Once more, thank you.

[Ruadh in reply to Jimmy2008]

Apologies for picking this up a bit on the late side. Jimmy - you say borderline, then may one suggest Prolia may not be such a good approach for you ! Instead, check Amazon for the following publication - 'Your Bones' by Lara Pizzorno. All about osteoporosis - I had a similar osteoporosis diagnosis to yourself, and this some years ago now, when I happened to pick up information on 'Your Bones'. I got the book, followed the protocol as laid out by Pizzorno, and bingo. Dexa scans now normal. Relief. As had been prescribed one of the BIS drugs, and after checking em out, decided 'No way'!

Alternatives are one way to treat - Worked for Pizzorno herself and for many another who have followed her protocol. Remember though, do discuss with your medical team. OK ? Take care.

[Jimmy2008 in reply to Ruadh]

Wow, so much to consider. The book - Your Bones is on it’s way to me. Thanks Rusdh!

[Jan_Noack]

personally if it was me and not advice I would continue with the calc/mag and K2 and exercise too. i wish I was only borderine. another thing to think about is, with prolia, once on if you stop the rebound will very liley cause problem ..ue fractures tc..as the enzy,es change.. ok for someone maybe over 85 to stay over for life.. I guess? But if you are consider not staying on for life..do not start it..at least that was what I figured out when I looked at it 3 years ago... I should be taking somethng though. estradiol improved my BMD but still higher than Z=-3.2 (was Z=-3.8)