Romosozumab offers significant benefit in osteoporosis in post menopausal women
Romosozumab offers significant benefit leading to fewer vertebral fractures and fewer other typical fractures in high risk postmenopausal women with severe osteoporosis;
Romosozumab is a bone-forming monoclonal antibody used in women after menopause for the treatment of severe osteoporosis if there is a high risk of bone fractures. Having been granted approval for this therapeutic indication by the European Medicines Agency in December 2019, it has been available on the German market since March 2020.
The German Institute for Quality and Efficiency in Health Care (IQWiG) now examined in an early benefit assessment whether romosozumab offers an added benefit for the affected women in comparison with the appropriate comparator therapy. The result: Overall, there are only positive effects from treatment with romosozumab followed by treatment with alendronic acid in comparison with the appropriate comparator therapy (here: treatment with alendronic acid alone). In particular, administration of romosozumab reduces both the risk of vertebral fractures and the risk of other typical fractures.
In summary, IQWiG sees an indication of considerable added benefit for postmenopausal women with advanced osteoporosis at high risk of fracture if they are treated with romosozumab (followed by alendronic acid).
More than 540 000 women affected
Osteoporosis is a common age-related bone disease. As the bone becomes thinner and more porous, the risk of fracture is increased. Besides fractures of the spine ("vertebral fractures"), the most typical sites of fracture are the hip, the pelvis, the upper arm and the forearm ("non-vertebral fractures"). About 80 per cent of all cases of osteoporosis affect women after menopause. In Germany, more than 540 000 of these women have severe, i.e. advanced osteoporosis at high risk of fracture. The number of affected women in the statutory health insurance is about 475 000.
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