(37) Comparative Effectiveness of Romosozumab to Denosumab in the Treatment of Osteoporosis in Postmenopausal Women: A Systematic Review

Background

Romosozumab (Evenity®) is a sclerostin inhibito and is approved for the treatment of osteoporosis in postmenopausal women who are at a high risk of bone fracture or have had a limited response to other osteoporosis medications. While Romosozumab is the latest approved therapy for the treatment of osteoporosis in this population, other medications include bisphosphonates, RANKL inhibitors, Calcitonin, SERMs, and parathyroid hormone analogs. Denosumab (Prolia®) is the only other monoclonal antibody therapy that is approved for osteoporosis treatment. The effectiveness of Romosozumab in the treatment of osteoporosis as compared with other agents has not been widely assessed. 

Objective

The objective of this study is to compare the effectiveness of romosozumab to denosumab for the treatment of osteoporosis in postmenopausal women. An initial search was conducted in PubMed and EMBASE using a search strategy designed according to the Population, Intervention, Comparator, and Outcome (PICOS) criteria to address the question: in female patients with postmenopausal osteoporosis who are at a high risk of fractures, is Romosozumab more effective than Denosumab in reducing fracture risk? 

Methods

We conducted a systematic review using PubMed and EMBASE to identify relevant studies based on PICOS criteria. The key words used were osteoporosis and effectiveness and Denosumab and Romosozumab which resulted in 107 potential studies. Articles were chosen with the outcome of reductions in fracture risk as well as changes to bone mass density (BMD) to better assess effectiveness between Romosozumab and Denosumab.

Results

Five studies were analyzed for comparative information between outcomes. In two studies, Romosozumab significantly reduced risk of vertebral fracture as compared with Alendronate or placebo respectively. Romosozumab also significantly increased BMD in patients with low BMD. Compared with placebo, one year of Romosozumab treatment increased BMD of the lumbar spine and hip by 13.3% and 6.2% respectively. Another study showed similar gains in two years of Romosozumab treatment (15.1% at lumbar spine, 5.4% at hip). In comparison with Denosumab, 1 year of Romosozumab achieved similar gains in BMD to those seen after three years of continuous Denosumab treatment. In the treatment of Romosozumab for 12 months followed by 12 months of Denosumab, patients experienced similar gains in BMD as were found in patients treated with Denosumab for 7 years. These findings suggest therapy with Romosozumab can help increase BMD at a significantly faster rate than with Denosumab alone.

Conclusions

Romosozumab is effective in treating osteoporosis in postmenopausal women with high risk of fracture compared to Denosumab treatment alone. Romosozumab significantly increased BMD at the hip and lumbar spine when compared with other treatments, and more quickly increased the BMD when compared with Denosumab treatment. Romosozumab also significantly reduced fracture risk when compared with placebo and other treatments. Based on the research findings, Romosozumab has the greatest efficacy when used for 12-24 months before an antiresorptive agent like Denosumab. This sequential therapy allows the gains in BMD to persist after discontinuing Romosozumab. This may have the greatest beneficial impact on health outcomes for postmenopausal patients with a high risk of fractures.