12 November 2018

A twice-yearly injection of denosumab could improve spinal bone mineral density of patients with osteoporosis caused by transfusion-dependent thalassaemia (TDT), according to a new study.

Current standard therapy for people with TDT and osteoporosis is to treat with intravenous bisphosphonate agents such as pamidronate or zoledronic acid. However, researchers in Greece believe denosumab may be a better option, in terms of both efficacy and tolerability for patients.

The team undertook a single-site, randomised, placebo-controlled, double blind phase IIb trial with 63 patients to evaluate the efficacy and safety of denosumab in patients with TDT and osteoporosis.

Of those, 32 were randomly assigned to receive 60mg of denosumab every 6 months, while the remaining 31 were given a placebo. Each patient was also given daily supplements of calcium and vitamin D throughout the year-long study.

The participants’ bone mineral density was measured in the L1-L4 lumbar spine, the wrist, and the femoral neck.

Writing in the journal Blood Advances, the research team report that those receiving denosumab had a 5.92% increase in lumbar bone density, compared to a 2.92% increase in the placebo group.

The people who had denosumab also lost less bone mineral density in their wrist compared to placebo. The denosumab group also reported a significant reduction in pain compared to those in the placebo group.

Senior study author Dr Evangelos Terpos, of the National and Kapodistrian University of Athens, said: “Not only is denosumab associated with improved bone health and reduced pain, but its ease of administration may very well make this drug superior to bisphosphonates for the treatment of osteoporosis in patients with TDT and osteoporosis.”

A study directly comparing denosumab with the standard-of-care bisphosphonate zoledronic acid is ongoing.

Source: Voskaridou, E., Ntanasis-Stathopoulos, I., Papaefstathiou, A., Christoulas, D., Dimopoulou, M., Repa, K., Papatheodorou, A., Peppa, M., Terpos, E. (2018) “Denosumab in transfusion-dependent thalassemia osteoporosis: a randomized, placebo-controlled, double-blind phase 2b clinical trial”,  Blood Advances, available at doi: 10.1182/bloodadvances.2018023085


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