Long-term treatment of osteoporosis: safety and efficacy appraisal of denosumab Full Text
Therapeutics and Clinical Risk Management, 06/20/2012
Anastasilakis AD et al. - Denosumab is characterized by reversibility of its effect after treatment discontinuation, in contrast with bisphosphonates. Large-scale clinical trials, including the extension of FREEDOM trial for up to 5 years, are reassuring for its safety.
- Denosumab is a fully human monoclonal antibody to the receptor activator of nuclear factor-kB ligand (RANKL), a member of the tumor necrosis factor receptor superfamily essential for osteoclastogenesis.
- Denosumab treatment is associated with a rapid, sustained, and reversible reduction in bone turnover markers, a continuous marked increase in bone mineral density at all sites, and a marked decrease in the risk of vertebral, hip, and nonvertebral fractures in women with postmenopausal osteoporosis.
- Therefore, it could be considered as an effective alternative to previous bisphosphonate treatment as well as first-line treatment of severe osteoporosis.
- Cost-effectiveness studies support this suggestion.
- In addition, denosumab seems to be the safest treatment option in patients with impaired renal function.