Trial Watch: Amgen’s Denosumab Effective in Transfusion-Dependent Thalassemia-Induced Osteoporosis

Healio reports that the National and Kapodistrian University in Athens, Greece, investigators report that twice-yearly injections of Amgen’s denosumab improves spinal bone mineral density among individuals with osteoporosis cased by transfusion-dependent thalassemia based on a randomized phase 2b study published in Blood Advances.

The study’s primary objective was to evaluate the effect of treatment on lumbar spine bone mineral density compared with placebo. Secondary objectives included evaluation of the effect on femoral neck and wrist bone mineral density, pain scores and markers of bone remodeling, as well as safety. Results at one year showed a mean 5.92 percent increase in lumbar bone density among patients who received denosumab, compared with a 2.92 percent increase among patients assigned placebo (P = .043). Further comparison showed patients in the denosumab group lost less bone mineral density in the wrist (– 0.26% vs. – 3.92%; P = 0.35) and had increased density in the femoral neck (4.08% vs. 1.96%).

Lead Research/Investigator

Evangelos Terpos, MD