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Romo in Roma - Phase 2 Trial of a Potential New Agent for OP
June 12 2015 12:36 PM ET — via RheumReports
Today at EULAR, Dr. Michael McClung reported the results of a trial entitled "Effects of 2 years of Romosozumab (Romo) followed by one year of Denosumab vs placebo in post menopausal women with low bone density."
Romo is an antisclerostin antibody (proven in a previous 1-year trial by the same authors) to be efficacious with greater improvements in BMD than placebo, alendronate or teriparitide. This trial was the phase 2 dose-finding extension. Postmenopausal women with low BMD were divided into 5 groups to receive 5 doses of romo given SC monthlyfor 2 years followed by 1 year of either placebo or denosumab.
The highest dose of 210mg yielded the best results on BMD in the lumbar spine and hip, and this is the dose which will be carried forward into the phase 3 studies. During the second year, sustained improvement in BMD was seen with continued suppression of bone turnover markers P1NP and CTX, though not at the same magnitude as seen in the first year. Mild injection site reactions were reported but there were no new safety signals.
In the third year, patients were re-randomized to placebo or denosumab. There was a rapid decline of BMD to baseline in the placebo group but in the denosumab group there was continued improvement in BMD and suppression of markers similar to what was seen in the second year with romo.
Two large phase 3 trials are now underway including an arm which looks at bisphosphonates as well as denosumab for maintenance. It will be interesting to see bone biopsy results and fracture data for this novel approach of induction therapy followed by maintenance.
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About the Author
Dr. Shelly Dunne
Dr. Shelley Dunne is a graduate of Memorial University of Newfoundland School of Medicine. She completed her training in Internal Medicine and a fellowship in Rheumatology at the University of Toronto. She has been in private practice since 1998 and is currently a consulting rheumatologist at the Toronto East General Hospital.
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