[Show abstract][Hide abstract] ABSTRACT: Osteoporosis is a major public health care concern. Although often described as a disease affecting postmenopausal women, researchers and clinicians have emphasized its prevalence in men in recent years. The National Osteoporosis Foundation has stated that up to 25% of men over the age of 50 years will experience a fracture due to osteoporosis. Men who suffer from a major fracture have higher mortality rates than women. Pharmacologic therapy options for treating osteoporosis are limited for men as compared with women, so each medication approved for use in this population represents an important clinical option. In September 2012, the US Food and Drug Administration approved a new indication for denosumab to increase bone mass in men with osteoporosis at high risk for fracture. Denosumab is a fully human monoclonal antibody and novel antiresorptive agent that works by binding receptor activator of nuclear factor kappa-β ligand (RANKL) and inhibiting the signaling cascade that causes osteoclast maturation, activity, and survival. Ultimately, denosumab suppresses bone turnover and increases bone mineral density in both trabecular and cortical bone. Approval for treating osteoporosis in men was based on data from the ADAMO trial which displayed efficacy in increasing bone mineral density at the lumbar spine, total hip, femoral neck, hip trochanter, and one-third radius. Studies indicate that denosumab is effective and safe, and has superior adherence rates and patient satisfaction. Although long-term data and further research on fracture reduction rates in men should be explored, at this time denosumab is one of several appropriate first-line treatment options for men with osteoporosis.
[Show abstract][Hide abstract] ABSTRACT: To review the evidence for use of denosumab for the treatment of postmenopausal osteoporosis.
A search of MEDLINE and EMBASE databases was conducted during January 2012, using the terms denosumab and osteoporosis, with index dates of 2000 to 2011. Additional information was gathered from Amgen and references cited in articles retrieved.
English-language articles including clinical trials involving denosumab for treatment of osteoporosis and review articles were reviewed. Articles using denosumab in males or as treatment for conditions other than osteoporosis or osteopenia were excluded.
Many clinical trials have supported the safety and efficacy of denosumab in postmenopausal women with bone loss. It has been shown to improve bone mineral density, decrease markers of bone turnover, and prevent new vertebral fractures. It shows improvement over placebo in studies and has at least similar efficacy to alendronate in measurements of bone mineral density, with less risk for osteonecrosis of the jaw and atypical fracture, but with an increased risk of infections and neoplasms. European cost-effectiveness studies have also demonstrated that denosumab is a cost-effective choice compared to risedronate and no treatment for fracture prevention for postmenopausal women with osteoporosis.
Denosumab has demonstrated efficacy and safety as a first-line treatment for postmenopausal osteoporosis in multiple clinical trials over at least 6 years. It may be most cost-effective for women who are unable or refuse to take bisphosphonate drugs.
Annals of Pharmacotherapy 07/2012; 46(7-8):1000-9. DOI:10.1345/aph.1Q543 · 2.06 Impact Factor