Table 2.
Risk of Fracture, Overall and by Type, by Treatment Group
Pioglitazone (n = 1939) |
Placebo (n = 1937) |
Risk ∆ (%)c | HR (95% CI) | |||||
---|---|---|---|---|---|---|---|---|
Fractures | Ptsa | Risk (%)b | Fractures | Ptsa | Risk (%)b | |||
Any fracture | 376 | 218 | 13.6 | 225 | 145 | 8.8 | 4.9 | 1.53 (1.24–1.89) |
Energy | ||||||||
Low energy | 295 | 178 | 11.2 | 184 | 119 | 7.2 | 4.0 | 1.51 (1.20–1.91) |
High energy | 67 | 35 | 2.1 | 31 | 22 | 1.3 | 0.8 | 1.60 (0.94–2.73) |
Unknown | 14 | 14 | 0.9 | 10 | 8 | 0.5 | 0.5 | 1.86 (0.74–4.66) |
Stress | ||||||||
Nonstress | 353 | 204 | 12.8 | 204 | 137 | 8.3 | 4.5 | 1.51 (1.22–1.88) |
Stress | 15 | 10 | 0.6 | 14 | 8 | 0.6 | 0.0 | 1.25 (0.49–3.17) |
Unknown | 8 | 8 | 0.5 | 7 | 6 | 0.4 | 0.1 | 1.40 (0.44–4.41) |
Pathology | ||||||||
Nonpathologic | 371 | 215 | 13.4 | 214 | 141 | 8.6 | 4.9 | 1.55 (1.26–1.92) |
Pathologic | 3 | 3 | 0.2 | 6 | 3 | 0.2 | 0.0 | 1.00 (0.20–4.96) |
Unknown | 2 | 2 | 0.1 | 5 | 4 | 0.2 | −0.1 | 0.50 (0.09–2.72) |
Serious/nonseriousd | ||||||||
Serious | 178 | 99 | 6.2 | 99 | 62 | 3.7 | 2.4 | 1.61 (1.17–2.21) |
Nonserious | 190 | 128 | 8.2 | 123 | 92 | 5.6 | 2.6 | 1.41 (1.07–1.84) |
Unknown | 8 | 6 | 0.4 | 3 | 2 | 0.1 | 0.3 | 3.00 (0.61–14.89) |
Low energy, nonpathologice | 292 | 176 | 11.1 | 178 | 118 | 7.2 | 3.9 | 1.51 (1.19–1.90) |
Serious, low energy, nonpathologicd,e | 127 | 76 | 4.7 | 83 | 52 | 3.1 | 1.6 | 1.47 (1.03–2.09) |
Number of participants with fracture.
Fracture risk at 5 years from Kaplan–Meier life table.
RD at 5 years from Kaplan–Meier life table.
Fracture considered serious if surgery, procedure, or hospitalization required.
Restricted fracture is defined as low-energy and nonpathologic fracture.