Denosumab

 

Update: 27 September 2019

No update available

 

Update: 30 July 2019

Sandoz, a Novartis division focusing on biosimilars have enrolled the first patient in an intergrated Phase I/III study for the development of denosumab for use in osteoporosis.

Sources:

https://www.novartis.com/news/media-releases/sandoz-announces-first-patient-enrolled-clinical-study-proposed-biosimilar-denosumab-osteoporosis

 

Update: 30 May 2019

No update available.

 

Update: 29 March 2019

No update available.

 

Update: 01 February 2019

No update available.

 

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.

Source:

https://www.healio.com/hematology-oncology/hematology/news/in-the-journals/%7Baf226409-78e8-4f41-9153-874a91937f7b%7D/denosumab-effective-in-transfusion-dependent-thalassemia-induced-osteoporosis