6. Drug‐related adverse events reported in randomised placebo‐controlled trials.
Study ID | Comparison | Side effect | Bisphosphonate | Placebo | RR (95% CI) |
Altman 1973 | Etidronate (38) vs. placebo (9) | Diarrhoea | 5 (13%) | 1 (11%) | 1.18 (0.16 to 8.93) |
Buckler 1999 | Zoledronate (141) vs. placebo (35) | Fatigue Fever Arthralgia Pain, back Pain, skeletal Hypocalcaemia |
12 (9%) 7 (5%) 15 (11%) 14 (10%) 11 (8%) 3 (2%) |
0 (0%) 0 (0%) 3 (9%) 1 (3%) 2 (6%) 0 (0%) |
6.34 (0.38 to 104.5) 3.80 (0.50 to 28.88) 1.24 (0.89 to 1.77) 3.47 (0.53 to 23.02) 1.37 (0.85 to 2.19) 1.78 (0.74 to 4.24) |
Fraser 1997 | Tiludronate (86) vs. placebo (26) | Nausea Vomiting Dyspepsia Diarrhoea Arthralgia Skeletal pain Raised liver enzymes Eosinophilia |
15 (17%) 7 (7%) 9 (10%) 14 (16%) 8 (9%) 5 (6%) 1 (1%) 0 (0%) |
2 (8%) 0 (0%) 0 (0%) 0 (0%) 2 (8%) 3 (12%) 0 (0%) 1 (4%) |
2.27 (0.65 to 7.86) 4.66 (0.45 to 48.06) 5.90 (0.40 to 87.16) 9.00 (0.32 to 252.8) 1.21 (0.91 to 1.61) 0.50 (0.13 to 1.97) 0.93 (0.04 to 22.20) 0.10 (0.01 to 2.47) |
McClung 1995 | Tiludronate (91) vs. placebo (48) | Gastrointestinal | 31 (34%) | 15 (31%) | 1.09 (0.66 to 1.81) |
Reginster 1992 | Tiludronate (117) vs. placebo (32) | Gastralgia Nausea |
20 (17.1%) 11 (9.4%) |
5 (16.1%) 3 (9.6%) |
1.09 (0.45 to 2.69) 1.00 (0.30 to 3.38) |
Reid 1996 | Alendronate (27) vs. placebo (28) | Gastrointestinal Gastritis Duodenal ulcer Oesophagitis |
2 (7%) 0 (0%) 0 (0%) 1 (4%) |
5 (18%) 1 (4%) 1 (4%) 0 (0%) |
0.42 (0.09 to 2.00) 0.35 (0.02 to 8.13) 0.35 (0.02 to 8.13) 3.10 (0.13 to 73.10) |