Short answer: Fracture risk goes up, including the risk of several spine fractures at once. The Prolia (denosumab) label says bone turnover rebounds above pretreatment levels about 9 months after the last shot and bone density returns to where it started within 18 months. In the main trial, 6% of women who stopped had new spine fractures and 3% had multiple. The label says people who stop should move to another antiresorptive medicine.
Section 5.6 of the Prolia label is titled "Multiple Vertebral Fractures (MVF) Following Discontinuation of Prolia Treatment". It says that after Prolia is stopped, fracture risk increases, including the risk of multiple vertebral (spine) fractures.
The reason is how the medicine works. Prolia strongly suppresses bone turnover, the constant breakdown and rebuilding of bone. When it is stopped, the label says turnover rises above pretreatment values 9 months after the last dose, then returns to pretreatment values 24 months after the last dose. Bone mineral density returns to pretreatment values within 18 months after the last injection.
New spine fractures occurred as early as 7 months (on average 19 months) after the last dose. The label names a prior spine fracture as a predictor of multiple spine fractures after stopping.
| Measure | What the label reports |
|---|---|
| New spine fractures | 6% of women who stopped Prolia and stayed in the study |
| Multiple new spine fractures | 3% of women who stopped Prolia and stayed in the study |
| Time to multiple spine fractures | Mean 17 months after the last injection (range 7 to 43 months) |
| Predictor | A spine fracture before stopping |
These are counts in people who stopped; the label does not compare them with people who stayed on Prolia in the same section.
Section 5.6 says to weigh benefit and risk before starting Prolia, and that if Prolia is discontinued, patients should be transitioned to an alternative antiresorptive therapy. The label does not name which medicine or say how soon.
This is different from bisphosphonates, whose labels say people at low fracture risk can be considered for stopping after 3 to 5 years; see how long you can take a bisphosphonate. Stopping Prolia is a planned decision with your prescriber, not a gap to let happen.
Prolia is 60 mg every 6 months, given by a healthcare provider (section 2.3). If a dose is missed, the label says to give it as soon as the patient is available and then schedule every 6 months from the date of that injection. The label does not say how late is too late. See missed a Prolia dose.
Dose Track can hold the date of each Prolia shot and remind you ahead of the next one, so the booking happens before the window passes.
Read more on Dose Track: Missed a Prolia dose · Prolia side effects · Prolia dosing schedule · Prolia vs Evenity