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The pros and cons of Prolia, Amgen’s new osteoporosis drug


5 Star

The pros and cons of Prolia, Amgen’s new osteoporosis drug

Our Review Summary

The story detailed what is known about the impact of this drug on various types of bone fractures associated with osteoporosis, how its mode of action is someone different than other osteoporosis treatments, its administration and how the costs compare with other treatments.  The one shortcoming of the story was that it had elements of disease-mongering, as explained below.


Why This Matters

 The gestalt about osteoporosis is that women should live in fear of bone breaks. While the story provided very good information about this new treatment, it did not provide much context about the problem. And its inconsistent use of relative vs. absolute risk/benefit data didn’t help.


Does the story adequately discuss the costs of the intervention?


 This story not only mentions the cost for this drug but also for other treatments for osteoporosis as well.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?


 The story did a great job of distinguishing among various fracture types and reporting both relative and absolute risk reduction for vertebra fracture. But then it was disappointing that the risk reduction for hip fractures and that of wrist, leg, or shoulder were reported as only relative risk reduction.  Since the story characterized hip fractures as ‘devastating’, it should have provided the reader with some sense of how frequently they occur rather than simply indicating how often they result in a person entering a nursing home or dying within 5 years of having one. Nonethless, because of the elements that were well done, we’ll give the story the benefit of the doubt on this criterion.

Does the story adequately explain/quantify the harms of the intervention?


The story gave a rather complete listing of the potential harms associated with the use of this drug, including specific mention of those problems that are unique to this drug as compared with other medications used to manage bone loss.  Although the list was complete, the story did not indicate the frequency with which these harms occurred. Nonethless, we’ll give the story the benefit of the doubt on this criterion.

Does the story seem to grasp the quality of the evidence?


The story provided information about the clinical trial it described, including the number of people studied, the length of time they were studied and the impact on various types of fractures.

Does the story commit disease-mongering?

Not Satisfactory

The story only indicated lifetime risks of fracture (i.e. 1 out of every 2 women over the age of 50) and that 25% of people die within 5 years of breaking a hip without providing some context for these concerns.  The 5 year risk of fracture for a woman aged 55 is not the same as that for a woman aged 75; similarly, there are other factors compounding the statistic about death following hip fracture.  

Since the drug is marketed as being for women who are postmenopausal, rather than simply parroting these seemingly alarming pieces of information, the story should have provided more context for these statistics.

This was one weak point in an overall strong story – but an important nuance that should not be overlooked.

Does the story use independent sources and identify conflicts of interest?


 Comments about this drug and its potential utility from two clinicians noted as not having industry ties to this or other osteoporosis drugs were included in this story.

Does the story compare the new approach with existing alternatives?


 This story compared the benefits, harms and costs for the new drug, with those treatments already on the market.

Does the story establish the availability of the treatment/test/product/procedure?


 The story opens with a statement about this drug’s approval by the FDA.

Does the story establish the true novelty of the approach?


 The story provided a useful explanation of how this medication differed from the other treatments available for osteoporosis.

Does the story appear to rely solely or largely on a news release?


 Does not appear to rely exclusively on a news release.

Total Score: 9 of 10 Satisfactory

Comments (7)

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Carol Brinton

June 27, 2013 at 11:32 am

When I clicked on READ THIS STORY, nothing came up. How can I access this?

Is this covered by Medicare?
Does the STORY give the benefits and drawbacks to Prolia?

Looking forward to your answer.

Thanks for your help,

Carol Brinton


Patricia Morrow

August 17, 2014 at 2:23 pm

I was given Prolia, I got a serious ear infection, my foot has been swollen, I have had radiation for Breast Cancer, I do not think I should have been given the shot, mainly because now I am anemic again.


Carole Crowe

August 28, 2014 at 9:34 am

I had my first Prolia infusion in June of 2014 and am experiencing ALL of the side effects. I’m in constant pain all over body and wonder if Prolia has any interaction with my 10 year ago diagnosis of Polymyalgia Neurotica which appears as my worst diagnosis as reported to me by my Primary Doc. . Please respond..Thanx



September 22, 2014 at 8:50 pm

The newspaper story you reviewed on Prolia was written in 2010. Can you advise where I might find more current, objective articles on this drug? Thank you.