Subcutaneous
denosumab (
Prolia(®) [USA, Europe]; Pralia(®) [Japan]) once every 6 months is indicated in several countries for the treatment of postmenopausal women with
osteoporosis at increased or high risk for fractures (featured indication). In some countries, it is also indicated for use in postmenopausal women who have failed or are intolerant to other
osteoporosis treatments. In several international, phase III trials (≤3 years' duration) involving more than 12,000 women with
postmenopausal osteoporosis or
low bone mineral density (BMD), including Asian studies,
denosumab was an effective and generally well tolerated treatment. Relative to placebo,
denosumab treatment significantly reduced the risk of vertebral, nonvertebral and
hip fractures and increased BMD at all skeletal sites evaluated, including the lumbar spine and total hip. Furthermore, the benefits of
denosumab treatment were generally evident after the first dose and were maintained during up to 8 years of treatment in an ongoing extension study. The tolerability profile of
denosumab during this extension phase was consistent with that observed during the initial 3-year FREEDOM trial. At 12 months,
denosumab treatment increased BMD at the total hip, lumbar spine and/or femoral neck and reduced markers of bone turnover to a significantly greater extent than oral
bisphosphonates in women who were essentially
bisphosphonate-naive and in those who had switched from
alendronate to
denosumab treatment. Further clinical experience, including an ongoing postmarketing safety study, will more fully define the long-term safety of
denosumab. In the meantime,
denosumab is an important option for the treatment of women with
postmenopausal osteoporosis at increased or high-risk of fractures, including in women at increased risk of fracture who are unable to take other
osteoporosis treatments.