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Table 2 Comparison of subject characteristics over time

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

 

FREEDOM baseline

Extension baseline

End of year 8

Placebo

(N = 3906)

Denosumab

(N = 3902)

Crossover denosumab

(N = 2207)

Long-term denosumab

(N = 2343)

Crossover denosumab

(N = 1462)

Long-term denosumab

(N = 1542)

Age, years

 Mean (SD)

72.3 (5.2)a

72.3 (5.2)a

74.8 (5.1)b

74.9 (5.0)b

79.0 (4.8)

79.1 (4.7)

 Median (range)

72 (60–91)

72 (60–90)

75 (63–93)

75 (63–93)

79 (68–98)

79 (68–94)

Age group, n (%)

  ≥ 70 years

2878 (74)

2872 (74)

1823 (83)

1974 (84)

1420 (97)

1505 (98)

  ≥ 75 years

1236 (32)a

1235 (32)a

1151 (52)b

1258 (54)b

1160 (79)

1255 (81)

  ≥ 80 years

346 (9)

322 (8)

379 (17)

407 (17)

676 (46)

737 (48)

Prior fracture, n (%)

 Prior vertebral

915 (23)a

929 (24)a

551 (25)b,c

573 (24)b,c

NA

NA

 Prior nonvertebrald

1177 (30)

1163 (30)

754 (34)c

780 (33)c

NA

NA

BMD T-score, mean (SD)

 Lumbar spine

–2.8 (0.7)a

–2.8 (0.7)a

–2.8 (0.8)b

–2.1 (0.8)b

–1.9 (0.9)

–1.6 (0.9)

 Total hip

–1.9 (0.8)a

–1.9 (0.8)a

–1.9 (0.8)b

–1.5 (0.8)b

–1.5 (0.8)

–1.3 (0.8)

  1. BMD bone mineral density, NA not applicable (because the prior fractures cannot be defined at the end of the treatment), SD standard deviation
  2. aPublished in Cummings et al, 2009 [1]
  3. bPublished in Papapoulos et al, 2012 [2]
  4. cIncludes incident fractures during FREEDOM
  5. dAt age ≥ 55 years