Table 12.
Study details and anti-fracture efficacy (relative risk (RR) and 95 % CI) of the major pharmacological treatments used for postmenopausal osteoporosis when given with calcium and vitamin D, as derived from randomised controlled trials
| Intervention | Study | Entry criteria | Mean age (years) | Number of patients randomised | Fracture incidence (% over 3 years)a | RR (95%CI) | |
|---|---|---|---|---|---|---|---|
| Placebo | Drug | ||||||
| a. Vertebral fracture (high-risk population) | |||||||
| Alendronate, 5–10 mg | [173] | Vertebral fractures; BMD, ≤0.68 g/m2 | 71 | 2,027 | 15.0 | 8.0 | 0.53 (0.41–0.68) |
| Risedronate, 5 mg | [177] | 2 vertebral fractures or 1 vertebral fracture and T-score ≤−2.0 | 69 | 2,458 | 16.3 | 11.3 | 0.59 (0.43–0.82) |
| Risedronate, 5 mg | [178] | 2 or more vertebral fractures—no BMD entry criteria | 71 | 1,226 | 29.0 | 18.0 | 0.51 (0.36–0.73) |
| Raloxifene, 60 mg | [161] | Vertebral fractures—no BMD entry criteria | 66 | 7,705 | 21.2 | 14.7 | 0.70 (0.60–0.90) |
| Teriparatide, 20 μgc | [198] | Vertebral fractures and FN or LS T-score ≤−1 if less than 2 moderate fractures | 69 | 1,637 | 14.0 | 5.0 | 0.35 (0.22–0.55) |
| Ibandronate, 2.5 mg | [179] | Vertebral fractures and LS −5 < T-score ≤ −2.0 | 69 | 2,946 | 9.6 | 4.7 | 0.38 (0.25–0.59) |
| Ibandronate, 20 mg | [291] | Vertebral fractures and LS −5 < T-score ≤ −2.0 | 70 | 708 | 9.6 | 4.9 | 0.50 (0.34–0.74) |
| Strontium ranelate, 2 g | [201] | Vertebral fractures, LS BMD ≤0.840 g/m2 | 69 | 1,649 | 32.8 | 20.9 | 0.59 (0.48–0.73) |
| Zoledronic acid, 5 mg | [185] | FN T-score ≤−2.5, ± vertebral fracture, or T-score ≤−1.5 and 2+ mild or 1 moderate vertebral fracture | 73 | 7,765 | 10.9 | 3.3 | 0.30 (0.24–0.38) |
| b. Vertebral fracture (low-risk population) | |||||||
| Alendronate, 5–10 mgd | [176] | FN T-score ≤−2 | 68 | 4,432 | 3.8 | 2.1 | 0.56 (0.39–0.80) |
| Alendronate, 5–10 mg d | [176] | Subgroup of women, T-score <2.5 | NA | 1,631 | 4.0 | 2.0 | 0.50 (0.31–0.82) |
| Raloxifene, 60 mg | [161] | FN or LS T-score ≤−2.5, ± vertebral fractures | 66 | 7,705 | 4.5 | 2.3 | 0.50 (0.40–0.80) |
| Denosumab, 60 mg | [210] | TH or LS ≤−2.5 and >−4; 60–90 years | 72 | 7,868 | 7.2 | 2.3 | 0.32 (0.26–0.41) |
| c. Hip fracture | |||||||
| Alendronate, 5–0 mg | [173] | Vertebral fractures with BMD ≤0.68 g/m2 | 71 | 2,027 | 2.2 | 1.1 | 0.49 (0.23–0.99) |
| Alendronate, 5–10 mg d | [176] | FN T-score ≤−2b | 68 | 4,432 | 0.8 | 0.7 | 0.79 (0.43–1.44) |
| Alendronate, 5–10 mg d | [176] | FN T-score ≤−2.5b (subgroup analysis) | NA | 1,631 | 1.6 | 0.7 | 0.44 (0.18–1.97) |
| Risedronate, 2.5 and 5 mg | [71] | T-score <−3b or <−2b and ≥1 non-skeletal risk factor for hip fracture (subgroup analysis osteoporotic patients 70–79 years) | 77 | 9,331 | 3.2 | 1.9 | 0.60 (0.40–0.90) |
| Raloxifene, 60 and 120 mg | [161] | FN or LS T-score ≤−2.5, ± vertebral fractures | 66 | 7,705 | 0.7 | 0.8 | 1.10 (0.60–1.90) |
| Strontium ranelate, 2 g | [202] | Osteoporosis (T-score <−2.5) with or without prior fracture | 77 | 4,932 | 3.4 | 2.9 | 0.85 (0.61–1.19) |
| Strontium ranelate, 2 g | [202] | Age ≥74 with T-score ≤−2.4b (subgroup analysis) | 80 | 1,977 | 6.4 | 4.3 | 0.64 (0.412–0.997) |
| Zoledronic acid, 5 mg | [185] | FN T-score ≤−2.5 or less, ± vertebral fracture, or T-score ≤−1.5 and 2+ mild or 1 moderate vertebral fracture | 73 | 7,765 | 1.4 | 2.5 | 0.59 (0.42–0.83) |
| Denosumab, 60 mg | [210] | TH or LS ≤−2.5 and >−4; age 60–90 years | 72 | 7,868 | 1.2 | 0.7 | 0.60 (0.37–0.97) |
FN femoral neck, LS lumbar spine, NA not available
aExcept where indicated in column 1
bBMD adjusted to NHANES population
c20-month study
d4.2-year study