Effect of denosumab on bone mineral density in Japanese women with osteopenia treated with aromatase inhibitors for breast cancer: subgroup analyses of a Phase II study

Figures & data

Table 1 Summary of baseline variables

Variable	Denosumab (n=100)
Start of AI therapy, n (%)
With denosumab	30
Before denosumab	70
Type of AI therapy, n (%)
Non-steroidal	89
Steroidal	11
Age, n (%)
<65 years	51
≥65 years	49
Time since last menstrual cycle, n (%)
≤5 years	13
>5 years	87
Body mass index (kg/m^2), n (%)
<25	76
≥25	24
Lumbar spine BMD T-score, n (%)
≤−1.0	53
>−1.0	47
Right femoral neck BMD T-score, n (%)
≤−1.0	64
>−1.0	36
Left femoral neck BMD T-score, n (%)
≤−1.0	62
>−1.0	38

Abbreviations: AI, aromatase inhibitor; BMD, bone mineral density.

Figure 1 Percentage change in bone mineral density in the lumbar spine from baseline (±95% CI) over 12 months in patients who started receiving AIs with denosumab (“With denosumab”) and those who had received AI before the initiation of denosumab therapy (“Before denosumab”).

Abbreviation: AIs, aromatase inhibitors.

Figure 2 Percentage change in bone mineral density in the right femoral neck from baseline (±95% CI) over 12 months in patients who started receiving AIs with denosumab (“With denosumab”) and those who had received AI before the initiation of denosumab therapy (“Before denosumab”).

Abbreviation: AIs, aromatase inhibitors.

Figure 3 Percentage change in BMD in the left femoral neck from baseline (±95% CI) over 12 months in patients who started receiving AIs with denosumab (“With denosumab”) and those who had received AI before the initiation of denosumab therapy (“Before denosumab”).

Abbreviations: AI, aromatase inhibitor; BMD, bone mineral density.

Table 2 Subgroup analyses of the therapeutic effects of denosumab at 12 months

	Lumbar spine	Right femoral neck	Left femoral neck
Start of AI therapy (n)
With denosumab (30)	4.5 (3.1, 5.8)	2.2 (0.5, 3.9)	1.0 (−0.8, 2.9)
Before denosumab (70)	4.7 (3.8, 5.7)	2.5 (1.4, 3.6)	1.5 (0.6, 2.5)
p-value	0.8385	0.7773	0.1972
Type of AI therapy (n)
Non-steroidal (89)	5.0 (4.2, 5.8)	2.6 (1.7, 3.5)	1.2 (0.3, 2.2)
Steroidal (11)	2.1 (−0.1, 4.2)	0.9 (−3.4, 5.3)	2.7 (0.9, 4.4)
p-value	0.0085*	0.1726	0.2931
Age (n)
<65 years (51)	4.5 (3.4, 5.6)	2.5 (1.3, 3.8)	1.4 (0.3, 2.5)
≥65 years (49)	4.9 (3.8, 5.9)	2.3 (0.9, 3.7)	1.3 (0.0, 2.6)
p-value	0.6306	0.7594	0.8817
Time since menopause (n)
≤5 years (13)	4.6 (2.6, 6.6)	2.1 (−0.4, 4.6)	−0.1 (−2.5, 2.2)
>5 years (87)	4.7 (3.8, 5.5)	2.4 (1.4, 3.4)	1.6 (0.7, 2.5)
p-value	0.9294	0.2034	0.1766
Body mass index (kg/m^2) (n)
<25 (76)	4.9 (4.0, 5.7)	2.1 (1.1, 3.1)	1.3 (0.3, 2.2)
≥25 (24)	4.6 (3.0, 6.1)	2.9 (0.8, 4.9)	1.9 (0.2, 3.7)
p-value	0.5867	0.2034	0.6465
T-score
≤−1.0	4.9 (4.0, 5.8)	2.3 (1.2, 3.3)	1.5 (0.3, 2.7)
>−1.0	4.4 (3.1, 5.7)	2.7 (0.9, 4.4)	1.1 (0.0, 2.3)
p-value	0.6678	0.6823	0.6573

Notes: Data are shown as the least squares mean percentage difference (95% CI).

* p<0.05.

Abbreviation: AI, aromatase inhibitor.