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Abstracts tagged "denosumab"

  • Abstract Number: 917 • 2014 ACR/ARHP Annual Meeting

    Evaluation of Invasive Oral Procedures and Events in Women with Postmenopausal Osteoporosis Treated with Denosumab: Results from the Pivotal Phase 3 Fracture Study Extension

    Nelson B. Watts1, John T. Grbic2, Michael McClung3, Socrates Papapoulos4, David Kendler5, Christence S. Teglbjaerg6, Lawrence O'Connor7, Rachel B. Wagman7, Eric Ng7, Nadia S. Daizadeh7 and Pei-Ran Ho7, 1Mercy Health Osteoporosis and Bone Health Services, Cincinnati, OH, 2Columbia University, New York, NY, 3Oregon Osteoporosis Center, Portland, OR, 4Leiden University Medical Center, Leiden, Netherlands, 5University of British Columbia, Vancouver, BC, Canada, 6Center for Clinical and Basic Research, Ballerup, Denmark, 7Amgen Inc., Thousand Oaks, CA

    Background/Purpose: Osteonecrosis of the jaw (ONJ) is a rare but serious adverse event of some antiresorptive therapies, including denosumab (DMAb), and invasive oral procedures and…
  • Abstract Number: 2316 • 2014 ACR/ARHP Annual Meeting

    Adherence to Denosumab in a Large Healthcare System

    Robert A. Overman1, Julie C. Lauffenburger2, Margaret L. Gourlay3 and Chad L. Deal4, 1Eshelman School of Pharmacy - Division of Pharmaceutical Policy and Outcomes, University of North Carolina, Chapel Hill, NC, 2Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, 3Family Medicine, University of North Carolina, Chapel Hill, NC, 4Dept of Rheum & Imm Dis /A 50, Cleveland Clinic, Cleveland, OH

    Background/Purpose: Oral bisphosphonates adherence has been reported as less than 50% at one year. Adherence to denosumab has been reported to be higher than alendronate…
  • Abstract Number: 2254 • 2014 ACR/ARHP Annual Meeting

    Changes in Subject Characteristics in the Denosumab Pivotal Fracture Trial and Its Extension for up to 8 Years

    JD Adachi1, CJF Lin2, PR Ho2, MA Bolognese3, HG Bone4, P Hadji5, S Papapoulos6, C Recknor7, NS Daizadeh2, P Dakin2, RB Wagman2 and S Ferrari8, 1McMaster University, Hamilton, ON, Canada, 2Amgen Inc., Thousand Oaks, CA, 3Bethesda Health Research Center, Bethesda, MD, 4Michigan Bone and Mineral Clinic, Detroit, MI, 5Philipps-University of Marburg, Marburg, Germany, 6Leiden University Medical Center, Leiden, Netherlands, 7United Osteoporosis Centers, Gainesville, GA, 8Geneva University Hospital, Geneva, Switzerland

    Background/Purpose: Changes in demographics of study population enrolled in long-term osteoporosis clinical trials may affect interpretation of efficacy/safety outcomes. Denosumab is being evaluated for up…
  • Abstract Number: 2264 • 2014 ACR/ARHP Annual Meeting

    Denosumab for Long-Term Glucocorticoid Users Who Have Inadequate Response to the Bisphosphonates: A 12-Month Randomized Control Trial

    Chi Chiu Mok1, Ling Yin Ho1 and Kwok Man Ma2, 1Medicine, Tuen Mun Hospital, Hong Kong, Hong Kong, 2Nuclear Medicine, Tuen Mun Hospital, Hong Kong, Hong Kong

    Background/Purpose To evaluate the efficacy of denosumab on bone mineral density (BMD) in long-term glucocorticoid users who have inadequate response to oral bisphosphonate treatment.Methods Patients…
  • Abstract Number: 1890 • 2014 ACR/ARHP Annual Meeting

    Consistent Inhibition of Bone Destruction By Denosumab in Important Subgroups of Japanese Patients with Rheumatoid Arthritis

    Naoki Ishiguro1, Yoshiya Tanaka2, Hisashi Yamanaka3, Toshiyuki Yoneda4, Takeshi Ohira5, Naoki Okubo6, Harry K. Genant7, Desiree van der Heijde8 and Tsutomu Takeuchi9, 1Orthopaedic Surgery and Rheumatology, Nagoya University Graduate School of Medicine, Nagoya, Japan, 2University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, 3Institute of Rheumatology, Tokyo Women’s Medical University, Tokyo, Japan, 4Indiana University School of Medicine, Indianapolis, IN, 5Daiich Sankyo Co. Ltd, Tokyo, Japan, 61-2-58, Hiromachi, Daiichi Sankyo Co. Ltd, Tokyo, Japan, 7University of California, San Francisco, CCBR-Synarc, Newark, Tiburon, CA, 8Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 9Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan

    Background/Purpose Denosumab is a fully human monoclonal antibody (IgG2 subclass) that binds specifically to RANKL, inhibits osteoclast-induced bone resorption by preventing the binding of RANKL…
  • Abstract Number: 1795 • 2014 ACR/ARHP Annual Meeting

    Denosumab Restores Cortical Bone Loss at the Distal Radius Associated with Aging and Reduces Wrist Fracture Risk: Analyses from the Cross-over Group in the Extension of the Denosumab Pivotal Fracture Trial

    JP Bilezikian1, CL Benhamou2, CJF Lin3, JP Brown4, NS Daizadeh3, PR Ebeling5, A Fahrleitner-Pammer6, E Franek7, N Gilchrist8, PD Miller9, JA Simon10, I Valter11, CAF Zerbini12 and C Libanati3, 1College of Physicians and Surgeons, Columbia University, New York, NY, 2CHR d'Orléans, Orléans, France, 3Amgen Inc., Thousand Oaks, CA, 4CHU de Québec Research Centre and Laval University, Quebec City, QC, Canada, 5Monash University, Clayton, Australia, 6Medical University, Graz, Austria, 7Medical Research Center, Polish Academy of Sciences, Warsaw, Poland, 8The Princess Margaret Hospital, Christchurch, New Zealand, 9Colorado Center for Bone Research, Lakewood, CO, 10George Washington University, Washington, DC, 11Center for Clinical and Basic Research, Tallinn, Estonia, 12Centro Paulista de Investigação Clinica, São Paulo, Brazil

    Background/Purpose: Cortical bone loss is a major determinant of increased fracture risk. Denosumab (DMAb) has been shown to increase BMD at sites of cortical bone,…
  • Abstract Number: 2800 • 2013 ACR/ARHP Annual Meeting

    Dose-Response Effects Of Denosumab, a Novel Subcutaneous RANKL Inhibitor, On The Progression Of Bone Erosion In Japanese Patients With Rheumatoid Arthritis Treated With Methotrexate: Results Of Phase II DRIVE Study – A Twelve Month Placebo Controlled, Randomized, Double Blind Study

    Tsutomu Takeuchi1, Yoshiya Tanaka2, Naoki Ishiguro3, Hisashi Yamanaka4, Toshiyuki Yoneda5, Harry K. Genant6 and Désirée van der Heijde7, 1Keio University School of Medicine, Tokyo, Japan, 2University of Occupational and Environmental Health, Kitakyushu, Japan, 3Nagoya University Graduate School of Medicine, Nagoya, Japan, 4Institute of Rheumatology Tokyo Women's Medical University, Tokyo, Japan, 5Indiana University School of Medicine, Indianapolis, IN, 6University of California, San Francisco, CCBR-Synarc, Newark, Tiburon, CA, 7Leiden University Medical Center, Leiden, Netherlands

    Background/Purpose: Denosumab is a fully human monoclonal antibody (IgG2 subclass) that binds specifically to RANKL. It inhibits osteoclast-induced bone resorption by preventing the binding of…
  • Abstract Number: 1384 • 2013 ACR/ARHP Annual Meeting

    Estimation Of The Effect Of Denosumab On Bone Loss From The Results Of The 12-Month Phase II Study In Patients With Rheumatoid Arthritis (RA) On Background Methotrexate (MTX)

    Yoshiya Tanaka1, Tsutomu Takeuchi2, Naoki Ishiguro3, Hisashi Yamanaka4, Toshiyuki Yoneda5, Harry K. Genant6 and Désiréé van der Heijde7, 1The First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, 2Keio University, Tokyo, Japan, 3Orthopaedic Surgery and Rheumatology, Nagoya University Graduate School of Medicine, Nagoya, Japan, 4Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, 5Indiana University School of Medicine, Indianapolis, IN, 6University of California, San Francisco, CCBR-Synarc, Newark, Tiburon, CA, 7Leiden University Medical Center, Leiden, Netherlands

    Background/Purpose: RANKL is an essential factor for osteoclast differentiation and activation. Denosumab, a fully human monoclonal IgG2 antibody, is a potent inhibitor of RANKL and…
  • Abstract Number: 1237 • 2013 ACR/ARHP Annual Meeting

    Denosumab Leads To Significantly Greater Increases In Bone Mineral Density Than Ibandronate and Risedronate In Postmenopausal Women At High Risk For Fracture Who Were Previously Treated With An Oral Bisphosphonate

    Jacques P. Brown1, Michael A. Bolognese2, Pei-Ran Ho3, Jesse Hall3, Christian Roux4, Henry G. Bone5, Sydney Bonnick6, Joop van den Bergh7, Irene Ferreira8, Prayashi Ghelani9, Paula Dakin3, Rachel B. Wagman3 and Chris Recknor10, 1CHU de Québec Research Centre and Laval University, Quebec City, QC, Canada, 2Bethesda Health Research Center, Bethesda, MD, 3Amgen Inc., Thousand Oaks, CA, 4Paris Descartes University, Paris, France, 5Michigan Bone and Mineral Clinic, Detroit, MI, 6Clinical Research Center of North Texas, Denton, TX, 7VieCuri Medical Centre and Maastricht University, Venlo, Netherlands, 8Amgen Inc., Cambridge, United Kingdom, 9Ovatech Solutions, London, United Kingdom, 10United Osteoporosis Centers, Gainesville, GA

    Denosumab Leads to Significantly Greater Increases in Bone Mineral Density Than Ibandronate and Risedronate in Postmenopausal Women at High Risk for Fracture Who Were Previously…
  • Abstract Number: 864 • 2013 ACR/ARHP Annual Meeting

    Further Reduction In Nonvertebral Fracture Rate Is Observed Following 3 Years Of Denosumab Treatment: Results With Up To 7 Years In The Freedom Extension

    Jonathan D. Adachi1, Serge Ferrari2, Carol Zapalowski3, Paul D. Miller4, Jean-Yves Reginster5, Ove Törring6, Nadia Daizadeh3, Andrea Wang3, Cynthia O'Malley7, Rachel B. Wagman3 and E. Michael Lewiecki8, 1McMaster University, Hamilton, ON, Canada, 2Geneva University Hospital, Geneva, Switzerland, 3Amgen Inc., Thousand Oaks, CA, 4Colorado Center for Bone Research, Lakewood, CO, 5University of Liège, Liège, Belgium, 6Karolinska Institutet, Södersjukhuset, Stockholm, Sweden, 7Center for Observational Research, Amgen, Inc., Thousand Oaks, CA, 8New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM

    Further Reduction in Nonvertebral Fracture Rate Is Observed Following 3 Years of Denosumab Treatment: Results With up to 7 Years in the FREEDOM ExtensionBackground/Purpose: Some…
  • Abstract Number: 491 • 2013 ACR/ARHP Annual Meeting

    Infection Risk Among Patients Receiving Concurrent Denosumab and Biologic Or Non-Biologic DMARD Therapy: An Analysis Of The Consortium Of Rheumatology Researchers Of North America (CORRONA) Registry

    Vance J. Bray1, Adam W. Bagley2, Sterling G. West3, Carol J. Etzel4, Joel M. Kremer5 and Jason R. Kolfenbach6, 1Denver Arthritis Clinic, Denver, CO, 2Internal Medicine, University of Colorado School of Medicine, Aurora, CO, 3Rheumatology, University of Colorado School of Medicine, Aurora, CO, 4Department of Epidemiology, UT MD Anderson, Houston, TX, 5Medicine, Albany Medical College and the Center for Rheumatology, Albany, NY, 6Division of Rheumatology, University of Colorado School of Medicine, Aurora, CO

    Background/Purpose: RANKL is a cytokine member of the tumor necrosis family that mediates osteoclastic bone resorption.  Denosumab prevents RANKL from activating RANK on the cell…
  • Abstract Number: 1998 • 2012 ACR/ARHP Annual Meeting

    Relationship Between Changes in Bone Mineral Density and Incidence of Fracture with 6 Years of Denosumab Treatment

    Michael A. Bolognese1, Paul D. Miller2, Jean-Yves Reginster3, Nathalie Franchimont4, Gerolamo Bianchi5, Roland Chapurlat6, Federico G. Hawkins7, David L. Kendler8, Beatriz Oliveri9, Jose R. Zanchetta10, Nadia Daizadeh4, Andrea Wang4, Rachel B. Wagman4 and Socrates Papapoulos11, 1Bethesda Health Research Center, Bethesda, MD, 2University of Colorado Health Sciences Center and Colorado Center for Bone Research, Lakewood, CO, 3Department of Public Health, Epidemiology and Health Economics, University of Liège, Liège, Belgium, 4Amgen Inc., Thousand Oaks, CA, 5LELICOMAR - Div Reumatologia, Azienda Sanitaria Genovese, Genoa, Italy, 6Hôpital Edouard Herriot, Lyon, France, 7Hospital Universitario, Madrid, Spain, 8University of British Columbia, Vancouver, BC, Canada, 9Laboratorio Enfermedades Metabólicas Oseas, Hospital de Clínicas, INIGEM UBA-CONICET, Buenos Aires, Argentina, 10Instituto de Investigaciones Metabólicas and University of Salvador, Buenos Aires, Argentina, 11Leiden University Medical Center, Leiden, Netherlands

    Background/Purpose: During the first 3 years of denosumab treatment in FREEDOM, there were continued increases in bone mineral density (BMD) and a robust reduction in…
  • Abstract Number: 1976 • 2012 ACR/ARHP Annual Meeting

    Treatment Satisfaction in Postmenopausal Women Previously Treated with Bisphosphonates Who Transitioned to Denosumab Vs Ibandronate Therapy in an Open-Label Study

    Santiago Palacios1, Giovanni Iolascon2, Irene Agodoa3, Hema Viswanathan3, Prayashi Ghelani4, Irene Ferreira5, Cynthia O'Malley6, Rachel B. Wagman7 and Sydney Bonnick8, 1Instituto Palacios, Madrid, Spain, 2Seconda Universita di Napoli, Naples, Italy, 3Amgen Inc, Thousand Oaks, CA, 4Ovatech Solutions, London, United Kingdom, 5Amgen Inc., Cambridge, United Kingdom, 6Center for Observational Research, Amgen, Inc., Thousand Oaks, CA, 7Amgen Inc., Thousand Oaks, CA, 8Clinical Research Center of North Texas, Denton, TX

    Background/Purpose: Higher treatment satisfaction is associated with greater persistence with osteoporosis therapy in postmenopausal women (Barrett-Connor OI 2012). Greater satisfaction has been reported with subcutaneous…
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