Skip to main content

Advertisement

Table 3 Top reasons for discontinuation during FREEDOM and during the Extension

From: Influence of subject discontinuation on long-term nonvertebral fracture rate in the denosumab FREEDOM Extension study

  FREEDOM (Years 1–3) Extension year 5 (Years 1–5)
Placebo (N = 3906) Denosumab (N = 3902) Crossover denosumab (N = 2207)a Long-term denosumab (N = 2343)a
Reasons for discontinuation, n (%) 700 (18) 630 (16) 745 (34) 801 (34)
 Consent withdrawn 403 (10) 344 (9) 325 (15) 337 (14)
 Other 20 (1) 32 (1) 170 (8)b 184 (8)b
 Adverse event 81 (2) 93 (2) 93 (4) 115 (5)
 Death 78 (2) 62 (2) 64 (3) 80 (3)
 Lost to follow-up 57 (1) 57 (1) 60 (3) 46 (2)
  1. aPublished in Papapoulos et al 2012 [2]
  2. bIncludes discontinuation after a protocol amendment to extend the Extension for an additional 5 years, which was associated with an increased discontinuation rate at the end of Extension year 2