Table 1.
Pharmacologic agent | Study | Patients with prevalent fractures (overall population or subgroup) | Fracture risk |
Reference | |
---|---|---|---|---|---|
Vertebral | Nonvertebral | ||||
SERM | |||||
Raloxifene | MORE | Severe vertebral fracturesa (subgroup) | RR 0.74 | RH 0.53 | 11 |
Prevalent vertebral fractures (subgroup) | RR 0.66/RR 0.54b | 12 | |||
CORE | Prevalent vertebral fractures (subgroup) | HR 0.78 | 13 | ||
Bazedoxifene | Phase 3 trial | Prevalent vertebral fractures (subgroup) | HR 0.55/HR 0.62c | 14 | |
≥1 moderate or severe vertebral fracture or multiple mild vertebral fractures and/or FN T-score ≤ −3.0 (subgroup) | HR 0.5 | 14 | |||
Bisphosphonates | |||||
Alendronate | FIT | ≥1 vertebral fracture (overall population) | RR 0.53/RH 0.45d | RH 0.72/RH 0.49g | 15 |
Risedronate | VERT-NA | ≥1 vertebral fracture (overall population) | RR 0.59 | RR 0.6 | 16 |
VERT-MN | ≥2 vertebral fractures (overall population) | RR 0.51 | RR 0.67 | 17 | |
Ibandronate | BONE | 1–4 prevalent vertebral fractures (overall population) | RR 0.38 | RR 0.31 | 18 |
1–4 prevalent vertebral fractures and FN T-score < −3.0 (subgroup) | 18 | ||||
Zoledronate | HORIZON-PFT | Prevalent vertebral fractures (63% of overall population) | RR 0.30 | HR 0.75/HR 0.59h | 20 |
HORIZON-RFT | Hip fracture (overall population) | HR 0.54e | HR 0.73/HR 0.70i | 22 | |
RANKL monoclonal antibody | |||||
Denosumab | FREEDOM | ≥2 vertebral fractures of any degree of deformity or ≥1 vertebral fracture of moderate or severe deformity (subgroup) | RR 0.45 | 24 | |
Parathyroid hormone | |||||
Teriparatide | FPT | ≥1 moderate vertebral fracture or ≥2 mild atraumatic vertebral fractures (overall population) | RR 0.35/RR 0.31f | RR 0.47/RR 0.46j | 26 |
BONE: the oral ibandronate osteoporosis vertebral fracture trial in North America and Europe, CORE: the continuing outcomes relevant to Evista, FIT: the fracture intervention trial, FN: femur neck, FREEDOM: the fracture reduction evaluation of denosumab in osteoporosis every 6 months, FPT: the fracture prevention trial, HORIZON-PFT: the health outcomes and reduced incidence with zoledronic acid once yearly-pivotal fracture trial, HORIZON-RFT: the health outcomes and reduced incidence with zoledronic acid once yearly-recurrent fracture trial, HR: hazard ratio, MORE: the multiple outcomes of raloxifene evaluation, RANKL: receptor activator of nuclear factor kappa-B ligand, RH: relative hazard, RR: relative risk, SERM: selective estrogen receptor modulator, VERT-NA: the vertebral efficacy with risedronate therapy-North America, VERT-MN: the vertebral efficacy with risedronate therapy-multinational.
Vertebral fracture severity assessed by the visual semiquantitative method.
RR 0.66 for raloxifene 60 mg and RR 0.54 for raloxifene 120 mg.
HR 0.55 for bazedoxifene 20 mg and HR 0.62 for bazedoxifene 40 mg.
RR 0.53 for morphometric vertebral fracture and RH 0.45 for clinical vertebral fracture.
HR 0.54 for clinical vertebral fracture.
RR 0.35 for teriparatide 20 μg and RR 0.31 for teriparatide 40 μg.
RH 0.72 for any clinical fracture including clinical vertebral fracture and RH 0.49 for hip fracture.
HR 0.75 for nonvertebral fracture and HR 0.59 for hip fracture.
HR 0.73 for nonvertebral fracture and HR 0.70 for hip fracture.
RR 0.47 for teriparatide 20 μg and RR 0.46 for teriparatide 40 μg.