MedicalResearch.com Interview with:
Bente Langdahl
Professor, Consultant, PhD, DMSc
Department of Endocrinology and Internal Medicine THG
Aarhus University Hospital
Aarhus Denmark
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Romosozumab is a humanised antibody against sclerostin currently in development for the treatment of osteoporosis. Romosozumab has a dual effect on bone; it stimulates bone formation and inhibits bone resorption. If this new treatment obtains regulatory approval and becomes available for the treatment of osteoporosis, some of the patients who will be candidates for this new treatment will already have been treated with other available treatments, for example, bisphosphonates. This study compared the effects of romosozumab and teriparatide, a currently available bone forming treatment, on bone mass, bone structure and bone strength. The results showed that the percent change from baseline in BMD at the total hip through month 12 (the primary endpoint) was significantly greater with romosozumab compared with teriparatide: 2.6 percent versus –0.6 percent, respectively (
p<0.0001). For the secondary endpoints; lumbar spine BMD by DXA, total hip and femoral neck BMD by DXA and QCT and bone strength estimated by finite element analysis patients treated with romosozumab had significantly larger increases from baseline compared with those taking teriparatide, with mean differences ranging from 3.1 percent to 4.6 percent (all
p-values <0.0001).
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