MedicalResearch.com Interview with:
Professor, Consultant, PhD, DMSc
Department of Endocrinology and Internal Medicine THG
Aarhus University Hospital
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).
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: Patients who have severe osteoporosis despite previous treatment with bone sparing agents such as bisphosphonates maybe still be in need for a treatment with a bone forming agent. These data suggest that Romosozumab may be more powerful than teriparatide to increase bone mass and bone strength in those patients. The study was not designed to investigate the effects of the two treatments on fracture prevention, so if the larger increases in bone mass and bone strength also lead to more profound fracture prevention is currently unknown.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: It will be important to investigate the effect of romosozumab on fracture prevention. Two phase III studies are currently investigating this.
MedicalResearch.com: Is there anything else you would like to add?
Response: Treatment with romosozumab was well tolerated.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Abstract presented at the April 2016 ENDO conference
(STudy evaluating effect of RomosozUmab Compared with Teriparatide in postmenopaUsal women with osteoporosis at high risk for fracture pReviously treated with bisphosphonatE therapy),
Superior Gains in Bone Mineral Density and Estimated Strength at the Hip for Romosozumab Compared with Teriparatide in Women with Postmenopausal Osteoporosis Transitioning from Bisphosphonate Therapy: Results of the Phase 3 Open-Label Structure Study
B Langdahl*1, C Libanati2, D B Crittenden3, M A Bolognese4, J P Brown5, N S Daizadeh3, E Dokoupilova6, K Engelke7, J S Finkelstein8, H K Genant9, S Goemaere10, L Hyldstrup11, E Jodar-Gimeno12, T M Keaveny13, D L Kendler14, P Lakatos15, J Maddox3, J Malouf16, F Massari17, J F Molina18, M R Ulla19 and A Grauer3
1Aarhus University Hospital, Aarhus, Denmark, 2UCB Pharma, Brussels, Belgium, 3Amgen Inc., Thousand Oaks, CA, 4Bethesda Health Research Center, Bethesda, MD, 5Laval University and CHU de QuÃ©bec (CHUL) Research Centre, Quebec City, QC, Canada, 6Medical Plus, Uherske Hradiste, Czech Republic, 7BioClinica, Inc., Hamburg, Germany, 8Department of Medicine, Massachusetts General Hospital, Boston, MA, 9Department of Radiology, University of California, San Francisco, CA, 10Ghent University Hospital, Gent, Belgium, 11Hvidovre University Hospital, Hvidovre, Denmark, 12Servicio de EndocrinologÃa, Hospital Universitario QuirÃ³n, Madrid, Spain, 13University of California at Berkeley, Berkeley, CA, 14University of British Columbia, Vancouver, BC, Canada, 15Department of Medicine, Semmelweis University, Budapest, Hungary, 16Universitat AutÃ²noma de Barcelona, Barcelona, Spain, 17Instituto de Investigaciones MetabÃ³licas, Buenos Aires, Argentina, 18Reumalab Centro Integral de Reumatologia, Medellin, Colombia, 19Instituto Latinoamericano de Investigaciones MÃ©dicas, Cordoba, Argentina
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Bente Langdahl (2016). Humanized Antibody Romosozumab May Increase Bone Mass In Resistant Osteoporosis Patients MedicalResearch.com