Table 4 Relative risk (95% CI) of new vertebral, hip and non-vertebral fractures compared with placebo in very elderly women receiving currently available osteoporosis treatments
From: Osteoporosis in Frail Patients: A Consensus Paper of the Belgian Bone Club
RCT | Included participants | N | Mean age (years) | Vertebral fractures | Hip fractures | Non-vertebral fractures | |
|---|---|---|---|---|---|---|---|
Alendronate | Post hoc analysis FIT Vertebral Fracture Arm (3 years) [90] | Women aged 75–82 years | 539 | Not specified | RR 0.62 95% CI 0.41–0.94 p < 0.05 p interact < 75 & ≥ 75 years NS | – | – |
Pooled analysis FIT Vertebral and Clinical Fracture Arm with low BMD (3–4 years) [91] | Women aged 55–80 years 55- < 65 years 65- < 70 years 70- < 75 years 75–85 years | 3658 | RR 0.55 95% CI 0.37–0.83 (constant RR) | RR 0.47 95% CI 0.27–0.81 (constant RR) | – | ||
Axelsson et al. [92] (5 years) | Women aged 71.1–92.3 years with a prior fracture | 110,190 | 82.4 Years | – | HR 0.72 95% CI 0.61–0.85 p < 0.001 | – | |
Risedronate | HIP - arm 2 (3 years) [93] | Women aged ≥ 80 years with at least one non-skeletal risk factor for hip fracture or T-score at FN ≤4 or ≤3 + hip axis length of ≥ 11.1 cm | 3886 | 83 Years | – | RR = 0.8 95% CI 0.6–1.2 p = 0.35 | 10.8% (Risedronate) versus 11.9% (placebo); p = 0.43 |
Post hoc pooled analysis VERT-NA, VERT-MN and HIP (3 years) [94] | Women aged ≥ 80 y with T-score ≤2.5 at FN or at least one prevalent vertebral fracture | 1392 | 83 years | HR 0.56 95% CI 0.39–0.81 p = 0.003 p interact < 80 & ≥ 85 years NS | – | 14.0% (Risedronate) versus 16.2% (placebo) p = 0.66 | |
Zoledronic acid | Post hoc analysis HORIZON-PFT and RFT (3 years) [95] | Women aged ≥ 75 years with T-score ≤ −2.5 at FN or ≥ 1 vertebral or hip fracture | 3888 | 79.4 years | HR 0.34 95% CI 0.21–0.55 p < 0.001 p interact < 75 & ≥ 75 years NS | HR 0.82 95% CI 0.56–1.2 p = 0.297 p interact < 70 & ≥ 75 years SS | HR 0.73 95% CI 0.60–0.90 p = 0.002 p interact < 70 & ≥ 75 years NS |
Denosumab | Post hoc analysis FREEDOM (3 years) [96] | Women aged ≥ 75 years | 2471 | 78.2 years | – | 0.9% (denosumab) versus 2.3% (placebo) p < 0.01; ARR 1.4% p interact < 75 & ≥ 75 years NS | – |
Preplanned analysis FREEDOM (3 years) [97] | Women aged ≥ 75 years | 2471 | 78.2 | RR 0.36 95% CI 0.25–0.53 p interact < 75 & ≥ 75 years NS | – | RR 0.84 95% CI 0.63–1.12 p interact < 75 & ≥ 75 years NS | |
Strontium ranelate | Preplanned pooled analysis SOTI and TROPOS (3 years) [98] | Women aged 80–100 years | 1488 | 83.5 years | RR 0.68 95% CI 0.50–0.92 p = 0.013 | RR 0.68 95% CI 0.42–1.10 p = 0.112 (not powered) | RR 0.69 95% CI 0.52–0.92 p = 0.011 |
Preplanned pooled analysis SOTI and TROPOS (5 years) [99] | Women aged 80–100 years | 1489 | 83.5 years | RR 0.69 95% CI 0.52–0.92 | RR 0.76 95% CI 0.50–1.15 (not powered) | RR 0.73 95% CI 0.57–0.95 | |
Teriparatide | Prespecified subgroup analysis FPT (19 months) [100] | Women aged ≥ 75 years | 244 | 78.3 years | RR 0.35 p < 0.05 p interact < 75 & ≥ 75 years NS | – | RR 0.75; p = 0.661 (not powered) p interact < 75 & ≥ 75 years NS |