- Romosozumab treatment for 12 months followed by alendronate resulted in a significantly lower risk of fracture in postmenopausal women with osteoporosis.
- The treatment was effective than alendronate alone, which is commonly used as first-line therapy for osteoporosis.
- Romosozumab is a monoclonal antibody that increases bone formation, and decreases bone resorption.
Treatment for osteoporosis with romosozumab and alendronate was effective in improving bone density and reducing the risk of fracture in postmenopausal women.
The new treatment for osteoporosis is more effective against fractures than the current standard treatment according to the study published in the New England Journal of Medicine (NEJM)
. The study is the first that compares the effect of two osteoporosis medicines on fractures.
‘The new treatment for osteoporosis with romosozumab followed by alendronate is more effective against fractures than the current standard treatment of alendronate alone.’
"With the new treatment, we could offer significantly better protection against fractures and could thereby help many patients with severe osteoporosis," says co-author of the study Mattias Lorentzon, Professor of Geriatrics at the Institute of Medicine, Sahlgrenska Academy, and Senior Physician at Sahlgrenska University Hospital.
About Romosozumab and Alendronate
Both romosozumab and alendronate are drugs prescribed for those with osteoporosis. Alendronate increases bone density by slowing the breakdown of bone and thereby decreasing the risk of fractures by 20-50%. The drug is an antiresorptive agent commonly used as first-line therapy for osteoporosis.
Romosozumab (Amgen and UCB Pharma) is a new bone-forming monoclonal antibody that binds to and inhibits sclerostin, a protein that stops bone formation. Romosozumab increases bone formation and decreases bone resorption.
Many patients with severe osteoporosis and a high risk of fractures often cannot regain their original bone strength. They continue to have fractures even with treatment according to current standards with alendronate in tablet form every week.
The situation is worse in those with osteoporosis. Elderly women, nonetheless continue to suffer broken bones, sometimes just by falling from a standing position. The fractures lead to disability and suffering, and with hip and vertebral fractures, often premature death.
Comparing the Effect of The Drugs
For the study 4,093 women, of an average age of 74 years, with osteoporosis and previous fractures were recruited. They were randomly allocated to 12 months' treatment with either alendronate or the new medication romosozumab.
Treatment with romosozumab thereby leads to rapid new bone formation. After the first 12 months, all patients received alendronate for 12 months.
- The risk of vertebral fracture in the course of the study proved to be 48 percent lower for those who received romosozumab compared with the group that received alendronate the whole time.
- The proportions suffering fractures was 6.2 percent in romosozumab group and 11.9 percent in alendronate group.
- The risk of a clinical fracture, such as an arm or leg fracture, was 27 percent lower in the group that received romosozumab.
The proportion of side effects and serious side effects was generally just as common in both of the treatment groups. However, it was observed that serious cardiovascular events, such as heart attack or stroke, occurred in 2.5 percent of the patients that received romosozumab compared with 1.9 percent in the group that received alendronate during the first 12 months of the study.
According to Mattias Lorentzon, the safety aspects of the new medication need to be studied further. However, an earlier study of nearly twice the size showed that romosozumab does not provide a greater risk of cardiovascular events compared with a placebo.
"With romosozumab in the treatment arsenal, we could prevent many fractures among the high-risk patients," he concludes.
- Mattias Lorentzon et al., Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis, NEJM (2017)