For patients with osteoporosis caused by transfusion-dependent thalassaemia (TDT), a twice-yearly injection of denosumab (DNM) appears to improve lumbar spine and wrist bone mineral density (BMD), according to a new study.
The research, published online in the journal Blood Advances, also suggests that the treatment could reduce pain and improve quality of life.
The randomised, placebo-controlled, double-blind, phase 2b clinical trial assigned participants to receive either 60 mg DNM (n=32) or placebo (n=31) subcutaneously on day 0 and 180.
After 12 months of follow-up, percentage increase of BMD at lumbar vertebrae 1-4 (L1-L4) was higher in the DNM group than the placebo group (5.92% vs 2.92%, P=.043). Wrist BMD was much higher compared with placebo (-0.26% vs -3.92%; P=.035).
DNM reduced pain scores that remained unaltered in the placebo group.
DNM was associated with a significant reduction in levels of soluble receptor activator of nuclear factor kappa-B ligand (sRANKL), sRANKL/osteoprotegerin ratio, C-telopeptide of collagen type I, tartrate-resistant acid phosphatase isoform-5b, and bone-specific alkaline phosphatase (ALP) between baseline and 12 months (P<.01 for all without changes in dickkopf-1 sclerostin osteocalcin.>
Placebo patients showed an increase in markers.
No grade 3 or 4 toxicity was observed.