Update: 20 December 2018
A single-site, placebo-controlled, double-blind phase 2b trial that included 63 patients with transfusion-dependent thalassaemia and bone mineral density T scores between -2.5 and -4 in at least one of three examined areas — lumbar spine, femoral neck or wrist bone, was conducted in Greece.
The study showed that a twice-yearly injection of denosumab, a fully human monoclonal antibody, improved spinal bone mineral density among individuals with osteoporosis caused by transfusion-dependent thalassaemia.
The treatment also reduced pain, making it superior to bisphosphonates for the treatment of osteoporosis in patients with transfusion-dependent thalassaemia and osteoporosis.
Denosumab is not yet approved by the FDA for use by patients with osteoporosis caused by transfusion-dependent thalassaemia.
Results at 1 year showed a mean 5.92% increase in lumbar bone density among patients who received Denosumab.