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- W2792210837 abstract "To the Editor: Dr Lamy and Dr Gonzalez-Rodriguez note that our analysis of risk of vertebral fractures after stopping denosumab, based on 0.2 to 0.5 years of median follow-up, may underestimate the risk of vertebral fractures during longer periods of follow-up. Indeed, our Discussion noted: “Because of the very short follow-up period, only a minority of participants who discontinued from Extension had a scheduled radiograph and, therefore, the analysis may have substantially underestimated the risk of vertebral fracture after discontinuing denosumab.”1 However, it is speculative and likely wrong to simply extrapolate a short-term rate to a long-term, 16-month risk. Assuming increased bone resorption plays a role in the increased rate of vertebral fracture, Miller and colleagues showed that resorption increases sharply after denosumab discontinuation and then returns toward normal over 18 months;2 likewise, the rate of vertebral fracture would also be higher early on after discontinuation and then decrease over time, as bone remodeling returns to baseline. A recent study found that, among 38 patients who were followed 17 months after the scheduled but omitted dose, 4 (10.5%) developed a vertebral fracture.3 The rates of new and worsening fractures in our analysis of participants who discontinued treatment are likely to be different from those in the entire FREEDOM and Extension studies. To explore this, we excluded participants who discontinued placebo or denosumab because of “disease progression” or “requirement for alternative therapy.” This did not change the rates per 100 participant-years (95% confidence interval) of vertebral fracture after discontinuing placebo (7.8 [4.4–11.1]) or denosumab (7.0 [5.1–9.0]), or our conclusion that the risk of new and worsening vertebral fractures increased to levels similar to the risk in untreated participants. Additionally, after these exclusions, the placebo participants had a 4.2% annual risk of fractures, just 1.2- to 2-fold higher than the whole placebo group in the FREEDOM trial.4" @default.
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- W2792210837 date "2018-03-01" @default.
- W2792210837 modified "2023-09-27" @default.
- W2792210837 title "Response to Dr Lamy and Dr Gonzalez-Rodriguez" @default.
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- W2792210837 doi "https://doi.org/10.1002/jbmr.3403" @default.
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