ARCH
Active-controlled Fracture Study in Postmenopausal Women with Osteoporosis at High Risk
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 4,093 postmenopausal women with high fracture risk, romosozumab followed by alendronate reduced new vertebral, clinical and hip fractures compared with alendronate alone.
N
4.093
Design
Active-controlled RCT, 24 mo
Endpunkt
New vertebral fracture
Relevanz
2
ErgebnisVertebral fracture −48 %; clinical fracture −27 %; hip fracture −38 %. Excess serious CV events in the romosozumab arm (2.5 % vs 1.9 %).
Saag KG, et al. N Engl J Med. 2017;377(15):1417-1427. 10.1056/NEJMoa1708322
Diskussion & Kritik
Anabolic-then-antiresorptive sequence beats antiresorptive alone — but the CV signal restricts use in patients with recent MI or stroke.