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Table 1 Demographics and other baseline characteristics of subjects with BMD data at baseline

From: Tibolone increases bone mineral density but also relapse in breast cancer survivors: LIBERATE trial bone substudy

   

Tibolone 2.5 mg (n= 345)

Placebo (n= 354)

   

Osteoporosis

(n= 39)

Osteopenia

(n= 165)

Normal

(n= 141)

Osteoporosis

(n= 43)

Osteopenia

(n= 152)

Normal

(n= 159)

Age (years)

       
  

Mean (SD)

55.3 (7.3)

53.1 (7.3)

52.9 (7.4)

56.8 (7.2)

53.3 (7.0)

52.2 (6.4)

  

Median (range)

55.0 (43, 73)

53.0 (32, 74)

53.0 (34, 72)

57.0 (42, 70)

53.0 (36, 71)

52.0 (39, 75)

Body mass index (kg/m 2 ) a

N

36

164

138

43

151

158

  

Mean (SD)

24.0 (3.5)

25.1 (4.6)

26.5 (3.8)

24.3 (4.0)

25.1 (4.1)

27.7 (4.8)

  

Median (range)

23.9 (18, 33)

23.8 (17, 52)

25.7 (19, 37)

24.0 (19, 37)

23.9 (19, 39)

26.9 (19, 48)

Time since menopause (years) a

N

35

143

116

39

135

134

  

Mean (SD)

10.5 (7.9)

6.9 (6.5)

7.3 (7.4)

8.4 (6.4)

7.1 (7.1)

5.0 (5.3)

  

Median (range)

8.4 (1, 35)

4.3 (0, 30)

4.6 (0, 31)

5.1 (0, 24)

4.3 (1, 30)

3.1 (0, 30)

Time since breast cancer surgery (years)

N

39

165

141

43

152

159

  

Mean (SD)

2.4 (1.2)

2.2 (1.2)

2.2 (1.3)

2.4 (1.5)

2.3 (1.3)

2.0 (1.2)

  

Median (range)

2.3 (0, 5)

2.0 (0, 5)

2.1 (0, 5)

2.4 (0, 5)

2.1 (0, 5)

1.7 (0, 5)

Race

n (%)

Asian

26 (66.7)

76 (46.1)

31 (22.0)

26 (60.5)

63 (41.4)

38 (23.9)

  

Black

    

1 (0.7)

1 (0.6)

  

Caucasian

13 (33.3)

85 (51.5)

109 (77.3)

16 (37.2)

86 (56.6)

118 (74.2)

  

Other

 

4 (2.4)

1 (0.7)

1 (2.3)

2 (1.3)

2 (1.3)

Smoking at baseline

n (%)

No

39 (100.0)

144 (87.3)

122 (86.5)

38 (88.4)

133 (87.5)

137 (86.2)

  

Yes

 

21 (12.7)

19 (13.5)

5 (11.6)

19 (12.5)

22 (13.8)

Alcohol use at baseline

n (%)

No

36 (92.3)

111 (67.3)

78 (55.3)

32 (74.4)

96 (63.2)

83 (52.2)

  

Yes

3 (7.7)

54 (32.7)

63 (44.7)

11 (25.6)

56 (36.8)

76 (47.8)

Estrogen-receptor status

n (%)

Negative

12 (30.8)

36 (21.8)

21 (14.9)

12 (27.9)

49 (32.2)

30 (18.9)

  

Positive

27 (69.2)

122 (73.9)

116 (82.3)

29 (67.4)

101 (66.4)

126 (79.2)

  

Unknown

 

7 (4.2)

4 (2.8)

2 (4.7)

2 (1.3)

3 (1.9)

Progestagen-receptor status

n (%)

Negative

11 (28.2)

45 (27.3)

28 (19.9)

16 (37.2)

58 (38.2)

39 (24.5)

  

Positive

27 (69.2)

110 (66.7)

106 (75.2)

25 (58.1)

86 (56.6)

111 (69.8)

  

Unknown

1 (2.6)

10 (6.1)

7 (5.0)

2 (4.7)

8 (5.3)

9 (5.7)

Aromatase Inhibitor a

n (%)

None

33 (84.6)

149 (90.3)

132 (93.6)

39 (90.7)

139 (91.4)

144 (90.6)

  

Ever, but not recent

1 (2.6)

3 (1.8)

 

1 (2.3)

4 (2.6)

2 (1.3)

  

Recent

5 (12.8)

13 (7.9)

9 (6.4)

3 (7.0)

9 (5.9)

13 (8.2)

Tamoxifen a

n (%)

None

13 (33.3)

36 (21.8)

29 (20.6)

15 (34.9)

48 (31.6)

29 (18.2)

  

Ever, but not recent

4 (10.3)

16 (9.7)

9 (6.4)

1 (2.3)

10 (6.6)

14 (8.8)

  

Recent

22 (56.4)

113 (68.5)

103 (73.0)

27 (62.8)

94 (61.8)

116 (73.0)

GnRH analoguesa

n (%)

None

34 (87.2)

159 (96.4)

133 (94.3)

41 (95.3)

144 (94.7)

147 (92.5)

  

Ever, but not recent

1 (2.6)

1 (0.6)

2 (1.4)

1 (2.3)

3 (2.0)

1 (0.6)

  

Recent

4 (10.3)

5 (3.0)

6 (4.3)

1 (2.3)

5 (3.3)

11 (6.9)

Chemotherapya

n (%)

None

11 (28.2)

52 (31.5)

54 (38.3)

12 (27.9)

55 (36.2)

59 (37.1)

  

Ever, but not recent

25 (64.1)

109 (66.1)

83 (58.9)

28 (65.1)

94 (61.8)

96 (60.4)

  

Recent

3 (7.7)

4 (2.4)

4 (2.8)

3 (7.0)

3 (2.0)

4 (2.5)

Node status

n (%)

Missing

    

1 (0.7)

 
  

Negative

18 (46.2)

90 (54.5)

86 (61.0)

20 (46.5)

80 (52.6)

93 (58.5)

  

Positive

21 (53.8)

75 (45.5)

55 (39.0)

23 (53.5)

71 (46.7)

66 (41.5)

  1. aStatistical analysis revealed no differences between groups for all of the above demographics and other baseline characteristics. Body mass index (P = 0.06) and time since menopause (P = 0.06) were the only two continuous variables close to significance. Comparison between tibolone and placebo randomized patients at baseline demonstrated no difference between groups for all of the demographics and other baseline characteristics. Body Mass Index (P = 0.06) and time since menopause (P = 0.06) were the only two continuous variables that came close to significance.
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Breast Cancer Research

ISSN: 1465-542X

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