Table 2 Primary and other BMD endpoints (BMD population)
BGF MDI 320/18/9.6 μg (N = 133) | BFF MDI 320/9.6 μg(N = 60) | GFF MDI 18/9.6 μg (N = 130) | |
|---|---|---|---|
Lumbar spine BMD (L2-L4) | |||
n | 128 | 57 | 123 |
Baseline, g·cm−2 (mean [SD]) | 1.18 (0.21) | 1.19 (0.20) | 1.16 (0.18) |
Change from baseline at Week 52, % (primary BMD endpoint) | |||
LSM | −0.09 | −0.12 | 0.38 |
95% CI | (−0.74, 0.56) | (− 1.09, 0.86) | (−0.28, 1.04) |
LSM % difference between treatments | |||
Versus GFF MDI 18/9.6 μg# | |||
LSM | −0.47 | −0.50 | NA |
95% CI | (−1.38, 0.45) | (− 1.69, 0.68) | |
Versus BFF MDI 320/9.6 μg¶ | |||
LSM | 0.03 | NA | Shown above |
95% CI | (−1.13, 1.20) | ||
Total hip BMD | |||
n | 128 | 57 | 119 |
Baseline, g·cm−2(mean [SD]) | 0.94 (0.15) | 0.98 (0.16) | 0.93 (0.14) |
Change from baseline at Week 52, % | |||
LSM | −0.87 | −1.12 | − 0.32 |
95% CI | (−1.39, −0.34) | (−1.90, − 0.33) | (− 0.86, 0.23) |
LSM % difference between treatments¶ | |||
Versus GFF MDI 18/9.6 μg | |||
LSM | −0.55 | −0.81 | NA |
95% CI | (−1.30, 0.21) | (−1.79, 0.16) | |
Versus BFF MDI 320/9.6 μg | |||
LSM | 0.25 | NA | Shown above |
95% CI | (−0.70, 1.21) | ||