Introduction
Materials and methods
Study design
Study procedures
Study outcomes
Statistical analysis
Results
Subject disposition
Baseline characteristics
Initial study baseline (month 0) | Month 48 baseline | |||
---|---|---|---|---|
No further active treatmenta (N = 51) | Zoledronate 5 mg IV single doseb (N = 90) | No further active treatmenta (N = 51) | Zoledronate 5 mg IV single doseb (N = 90) | |
Age, mean (SD), years | 67.2 (6.4) | 65.8 (5.6) | 71.8 (6.4) | 70.3 (5.6) |
BMD T-score, mean (SD) | ||||
Lumbar spine | − 2.32 (0.54) | − 2.34 (0.64) | − 1.04 (0.88) | − 1.28 (0.83) |
Total hip | − 1.63 (0.61) | − 1.42 (0.61) | − 1.29 (0.65) | − 1.16 (0.63) |
Femoral neck | − 1.98 (0.54) | − 1.86 (0.55) | − 1.70 (0.56) | − 1.63 (0.61) |
Serum P1NP, median (Q1, Q3), μg/L | 51.2 (37.4, 64.5) | 49.9 (39.2, 60.8) | 66.8 (51.0, 90.4) | 46.7 (33.2, 54.3) |
Serum β-CTX, median (Q1, Q3), ng/mL | 0.54 (0.42, 0.65) | 0.48 (0.37, 0.63) | 0.55 (0.44, 0.82) | 0.38 (0.30, 0.49) |
Efficacy
Bone mineral density
Bone turnover markers
Subgroup analysis
Safety
No further active treatment (N = 51)a n (%) | Zoledronate 5 mg IV single dose(N = 87)b n (%) | |
---|---|---|
All adverse events | 37 (72.5) | 73 (83.9) |
Serious adverse events | 8 (15.7) | 12 (13.8) |
Death | 1 (2.0) | 0 |
Leading to study discontinuation | 0 | 0 |
Adverse events of interest | ||
Osteoarthritis | 5 (9.8) | 7 (8.0) |
Potentially associated with hypersensitivity | 3 (5.9) | 3 (3.4) |
Malignancies | 0 | 2 (2.3) |
Hyperostosis | 0 | 0 |
Hypocalcemia | 0 | 0 |
Osteonecrosis of the jawc | 0 | 0 |
Atypical femoral fracturec | 0 | 0 |
Fragility fractured | 2 (3.9) | 2 (2.3) |