A Phase 2 study extension demonstrated that BMD at the lumbar spine and total hip increased at 16.8% and 6.9% compared to baseline for up to eight years among postmenopausal women with osteoporosis or low bone density who were on denosumab treatment.
Amgen added that overall, the incidence of adverse events was similar to that reported in the previous study.
Lead author Michael McClung, M.D., founding director, Oregon Osteoporosis Center, said:
"We don't yet have a cure for osteoporosis, and many postmenopausal women with this condition who are at high risk for fractures require long-term therapy for this serious disease. This study provides additional data that Prolia continues to increase bone mineral density progressively over a treatment period of eight years. This study supports the long-term clinical experience of Prolia for women with this chronic condition."
The Phase 2 study extension was carried out in order to find out what the effects of eight years of continued Prolia treatment might be on BMD and bone turnover markers.
The original Phase 2 trial included 412 postmenopausal women with a bone mineral density T-score between -1.8 and -4.0 (lumbar spine) and/or -1.8 and -3.5 (total hip or femoral neck). 262 of them completed the study, of which 200 took part in the extension study. All of them were administered Prolia, 60mg every 6 months.
OsteoporosisThe IOF (International Osteoporosis Foundation) refers to osteoporosis as the "silent epidemic". As the world population grows and gets older, the problem is increasing. Osteoporosis is a public health crisis, says WHO (World Health Organization). The IOF says governments and health authorities around the world should make osteoporosis a healthcare priority.
There were 3.79 million fractures linked to osteoporosis in Europe in 2000, hip fractures accounted for 890,000 of them. Hip fracture rates have increased considerably in Europe since 2000. By 2025, the USA is expected to have over three million fractures due to osteoporosis.
By 2050, Europe is expected to incur over €76.7 billion in direct medical costs linked to osteoporotic fractures, from €31.7 billion in 2000. Osteoporosis related fractures cost the USA an estimated $19 billion in 2005 - by 2025 it is expected to rise to about $25 billion.
Prolia (Denosumab)Prolia is a medication that targets an essential regulator of cells that break down bone (osteoclasts). It is approved in the United States for treating postmenopausal females with osteoporosis who are at high risk of fracture. It is also approved in the EU (European Union) for postmenopausal women who are at increased risk of fractures, and also for treating bone loss linked to hormonal ablation in males with prostate cancer who at at higher risk of fractures.
Prolia is administered once every six months, subcutaneously with a 60mg injection.