https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/prolia/prolia_pi.ahsx
This is the "official" document (sometimes called "labeling") from the manufacturer.
You may not have been given a copy of this, but now you have it to study and ask questions about!
What I learned from Amgen's information:
The following is what learned the prescribing information Amgen sent me early in 2018 to tell them about my "backbone disaster:"
- 5.6 Multiple Vertebral Fractures (MVF) Following Discontinuation of Prolia Treatment
5.6 Multiple Vertebral Fractures (MVF) Following Discontinuation of Prolia Treatment
Following discontinuation of Prolia treatment, fracture risk increases, including the risk of multiple vertebral fractures. Cessation of Prolia treatment results in markers of bone resorption increasing above pretreatment values then returning to pretreatment values 24 months after the last dose of Prolia. In addition, bone mineral density returns to pretreatment values within 18 months after the last injection.[see Pharmacodynamics (12.2) and Clinical Studies (14.1)].
New vertebral fractures occurred as early as 7 months (on average 19 months) after the last dose of Prolia. Prior vertebral fracture was a predictor of multiple vertebral fractures after Prolia discontinuation. Evaluate an individual’s benefit-risk before initiating treatment with Prolia.
If Prolia treatment is discontinued, consider transitioning to an alternative antiresorptive therapy [see Adverse Reactions (6.1)].
Following discontinuation of Prolia treatment, fracture risk increases, including the risk of multiple vertebral fractures. Cessation of Prolia treatment results in markers of bone resorption increasing above pretreatment values then returning to pretreatment values 24 months after the last dose of Prolia. In addition, bone mineral density returns to pretreatment values within 18 months after the last injection.[see Pharmacodynamics (12.2) and Clinical Studies (14.1)].
New vertebral fractures occurred as early as 7 months (on average 19 months) after the last dose of Prolia. Prior vertebral fracture was a predictor of multiple vertebral fractures after Prolia discontinuation. Evaluate an individual’s benefit-risk before initiating treatment with Prolia.
If Prolia treatment is discontinued, consider transitioning to an alternative antiresorptive therapy [see Adverse Reactions (6.1)].
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Patients may not see this. But if they did, and saw the word "discontinuation" they would likely take this to mean stopping a drug with the intent not to return, not a short delay.
And even if they had this document (most patients don't) they might not get to the sentence "New vertebral fractures occurred as early as 7 months... ." Which means that just as my fractures did, they could occur at just one month after the next shot was due.
Also, while I showed evidence of old vertebral fractures, this was never pointed out to me as a risk factor here. And no one at the University of Chicago (U. of C.) took this into account to warn me during the change of doctors that created the delay that resulted in fractures. Nor was this information in the patient information about the drug that I occasionally received with my Prolia shots.
So if you are thinking about Prolia for yourself or a loved one, get an updated version of this document and read it carefully (you should be able to find it online) so you will be able to ask your doctor about anything you don't understand.