FREEDOM
Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 7,868 postmenopausal women with osteoporosis, denosumab 60 mg subcutaneously every 6 months reduced new vertebral, non-vertebral and hip fractures compared with placebo.
N
7.868
Design
Double-blind RCT, 3 yr
Endpunkt
New vertebral fracture
Relevanz
2
ErgebnisVertebral fracture −68 % (p<0.001); hip fracture HR 0.60 (−40 %; p=0.04); non-vertebral −20 %.
Cummings SR, et al. N Engl J Med. 2009;361(8):756-765. 10.1056/NEJMoa0809493
Diskussion & Kritik
Effective and reversible — but the rebound multiple-vertebral-fracture phenomenon on discontinuation makes seamless sequential bisphosphonate therapy essential.