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Table 1 Characteristics of Extension enrollees and nonparticipants at FREEDOM baseline

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

 

Placebo

(N = 3906)

Denosumab

(N = 3902)

Combined

(N = 7808)

Extension nonparticipants

(N = 1699)

Extension enrollees

(N = 2207)

Extension nonparticipants

(N = 1559)

Extension enrollees

(N = 2343)

Extension nonparticipants

(N = 3258)

Extension enrollees

(N = 4550)

Age, years

 Mean (SD)

73.1 (5.3)

71.8 (5.1)a

73.0 (5.4)

71.9 (5.0)a,b

73.1 (5.4)

71.8 (5.0)

 Median (range)

73 (60–91)

72 (60–90)

73 (60–89)

72 (60–90)

73 (60–91)

72 (60–90)

Age group, n (%)

  ≥ 70 years

1307 (77)

1571 (71)

1200 (77)

1672 (71)

2507 (77)

3243 (71)

  ≥ 75 years

612 (36)

624 (28)a

573 (37)

662 (28)a,b

1185 (36)

1286 (28)

  ≥ 80 years

203 (12)

143 (6)

178 (11)

144 (6)

381 (12)

287 (6)

Prior fracture, n (%)

 Prior vertebral

430 (25)

485 (23)a

370 (24)

559 (24)a,b

800 (25)

1044 (23)

 Prior nonvertebralc

526 (31)

651 (29)

461 (30)

702 (30)b

987 (30)

1353 (30)

BMD T-score, mean (SD)

 Lumbar spine

–2.8 (0.7)

–2.8 (0.7)a

–2.8 (0.7)

–2.8 (0.7)a,b

–2.8 (0.7)

–2.8 (0.7)

 Total hip

–2.0 (0.8)

–1.9 (0.8)a

–1.9 (0.8)

–1.9 (0.8)a,b

–2.0 (0.8)

–1.9 (0.8)

FRAX® probability,d %, mean (SD)

 Hip

7.4 (7.7)

6.6 (7.3)

7.5 (8.0)

6.8 (7.2)

7.4 (7.8)

6.7 (7.3)

 Major osteoporotic

17.8 (9.8)

16.8 (9.7)

17.6 (9.9)

17.0 (9.6)

17.7 (9.8)

16.9 (9.6)

  1. BMD bone mineral density, FRAX ® Fracture Risk Assessment Tool, SD standard deviation
  2. aPublished in Papapoulos et al, 2012 [2]
  3. bPublished in Ferrari et al, 2015 [5]
  4. cAt age ≥ 55 years
  5. d10-year probability of fracture calculated with femoral neck BMD