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Abstracts tagged "denosumab"

  • Abstract Number: 1875 • ACR/ARP Annual Meeting 2019

    Subject Characteristics and Changes in Bone Mineral Density After Transitioning from Denosumab to Alendronate in the Denosumab Adherence Preference Satisfaction (DAPS) Study

    David Kendler1, Arkadi Chines 2, Patricia Clark 3, Peter R. Ebeling 4, Michael McClung 5, Yumie Rhee 6, Shuang Huang 2, Robert Kees Stad 7 and Nick Freemantle 8, 1University of British Columbia, Vancouver, BC, Canada, 2Amgen Inc., Thousand Oaks, CA, 3Hospital Infantil de Mexico Federico Gómez and National University of Mexico, Mexico City, Mexico, 4Monash University, Melbourne, Victoria, Australia, 5Oregon Osteoporosis Center, Portland, OR, 6Yonsei University College of Medicine, Seoul, Republic of Korea, 7Amgen Inc., Rotkreuz, Zug, Switzerland, 8University College London, London, England, United Kingdom

    Background/Purpose: There are limited data on patients transitioning from denosumab (DMAb) to bisphosphonates (BPs). The Denosumab Adherence Preference Satisfaction (DAPS) study (NCT00518531) reported that alendronate…
  • Abstract Number: 1876 • ACR/ARP Annual Meeting 2019

    Effect of Discontinuation of Denosumab in Subjects with Rheumatoid Arthritis Treated with Glucocorticoids

    Kenneth Saag1, Michele McDermott 2, Jonathan Adachi 3, Willem Lems 4, Nancy Lane 5, Piet Geusens 6, Peter Butler 2, Li Chen 2, Daria Crittenden 2, Robin Dore 7 and Stanley Cohen 8, 1University of Alabama, Birmingham, AL, 2Amgen Inc., Thousand Oaks, CA, 3McMaster University and St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada, 4VU University Medical Centre, Amsterdam, Netherlands, 5University of California at Davis Medical Center, Sacramento, CA, 6Maastricht University, Maastricht, Netherlands, 7Robin K Dore Inc, Tustin, CA, 8Metroplex Clinical Research Center, Dallas, TX

    Background/Purpose: Denosumab, a monoclonal antibody against RANKL, is approved for the treatment of glucocorticoid (GC) induced osteoporosis (GiOP). In postmenopausal women with osteoporosis, denosumab discontinuation…
  • Abstract Number: 2215 • ACR/ARP Annual Meeting 2019

    Modeling-Based Bone Formation Persists in the Femoral Neck Despite Remodeling Inhibition in Subjects Treated with Denosumab

    David Dempster1, Peter Butler 2, Mathias Bostrom 3, Jeri Nieves 1, Hua Zhou 4, Li Chen 2, Nicola Pannacciulli 2, Rachel Wagman 2 and Felicia Cosman 1, 1Columbia University, New York, NY, 2Amgen Inc., Thousand Oaks, CA, 3Hospital for Special Surgery, New York, NY, 4Helen Hayes Hospital, West Haverstraw, NY

    Background/Purpose: Denosumab (DMAb) is a potent antiresorptive agent, but findings in non-human primates suggest that modeling-based bone formation (MBBF) may persist despite DMAb treatment (Ominsky…
  • Abstract Number: 1818 • ACR/ARHP Annual Meeting 2018

    Greater BMD Gains with Denosumab Vs Risedronate in Glucocorticoid-Treated Subjects: Results from the Final 24-Month Analysis of a Randomized, Double-Blind, Double-Dummy Study

    Kenneth Saag1, Nicola Pannacciulli2, Piet Geusens3, Jonathan D. Adachi4, Osvaldo D. Messina5, Jorge Morales-Torres6, Ronald Emkey7, Peter W. Butler2, Xiang Yin2 and Willem F. Lems8, 1University of Alabama at Birmingham, Birmingham, AL, 2Amgen Inc., Thousand Oaks, CA, 3Maastricht University, Maastricht, Netherlands, 4McMaster University, Hamilton, ON, Canada, 5Cosme Argerich Hospital, Buenos Aries, Argentina, 6Hospital Aranda de la Parra, Leon, Mexico, 7Emkey Arthritis & Osteoporosis Clinic, Wyomissing, PA, 8VU University Medical Centre, Amsterdam, Netherlands

    Background/Purpose: Denosumab 60 mg subcutaneously every 6 months (Q6M) increased spine and hip BMD significantly more than risedronate 5 mg orally once daily (QD) at…
  • Abstract Number: 2299 • ACR/ARHP Annual Meeting 2018

    Subgroup Analysis of the Effect of Denosumab Compared with Risedronate on Percentage Change in Lumbar Spine Bone Mineral Density at 24 Months in Glucocorticoid-Treated Individuals

    Kenneth Saag1, Nicola Pannacciulli2, Piet Geusens3, Jonathan D. Adachi4, Eric Lespessailles5, Jorge Malouf6, Bente Langdahl7, Peter W. Butler2, Xiang Yin2 and Willem F. Lems8, 1University of Alabama, Birmingham, AL, 2Amgen Inc., Thousand Oaks, CA, 3Maastricht University, Maastricht, Netherlands, 4McMaster University, Hamilton, ON, Canada, 5University Hospital Orleans, Orleans, France, 6Hospital San Pablo, Barcelona, Spain, 7Aarhus University, Aarhus, Denmark, 8VU University Medical Centre, Amsterdam, Netherlands

    Background/Purpose: We previously demonstrated that denosumab increased lumbar spine and total hip bone mineral density (BMD) significantly more than risedronate at 12 and 24 months…
  • Abstract Number: 2313 • ACR/ARHP Annual Meeting 2018

    The Efficacy of Denosumab for Prevention of Osteoporotic Fractures in Patients with Connective Tissue Diseases Receiving Very High Doses of Glucocorticoid

    Keiichiro Kadoba, Keisuke Nishimura, Hiroki Mukoyama, Rintaro Saito, Daisuke Waki and Toshihiko Yokota, Department of Endocrinoligy and Rheumatology, Kurashiki Central Hospital, Kurashiki, Japan

    Background/Purpose: Osteoporosis is a common complication of glucocorticoid therapy, contributing to significant morbidity especially in patients receiving very high doses of glucocorticoid (GC). There have…
  • Abstract Number: 2809 • ACR/ARHP Annual Meeting 2018

    Skeletal Benefit/Risk of Long-Term Denosumab Therapy: A Virtual Twin Analysis of Fractures Prevented to Skeletal Safety Events Observed

    Serge Ferrari1, E. Michael Lewiecki2, Peter W. Butler3, David L Kendler4, Nicola Napoli5, Shuang Huang3, Daria B Crittenden3, Nicola Pannacciulli3, E.S. Siris6 and Neil Binkley7, 1Geneva University Hospital, Geneva, Switzerland, 2New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, 3Amgen Inc., Thousand Oaks, CA, 4University of British Columbia, Vancouver, BC, Canada, 5Campus Bio-Medico University of Rome, Rome, Italy, 6Columbia University Medical Center, New York, NY, 7University of Wisconsin–Madison Osteoporosis Clinical Center and Research Program, Madison, WI

    Background/Purpose: Osteoporosis is a chronic disease, yet skeletal safety events—atypical femoral fracture (AFF) and osteonecrosis of the jaw (ONJ)—remain a concern with long-term treatment. Ten…
  • Abstract Number: 323 • ACR/ARHP Annual Meeting 2017

    Evaluation of Invasive Oral Procedures and Events in Women with Postmenopausal Osteoporosis Treated for up to 10 Years with Denosumab: Results from a Phase 3 Open-Label Extension Study

    Nelson B. Watts1, John T. Grbic2, Neil Binkley3, Peter W. Butler4, Xiang Yin4, Antoniette Tierney4, Rachel B. Wagman4 and Michael McClung5, 1Mercy Health, Cincinnati, OH, 2Columbia University, New York, NY, 3University of Wisconsin School of Medicine and Public Health, Madison, WI, 4Amgen Inc., Thousand Oaks, CA, 5Oregon Osteoporosis Center, Portland, OR

    Background/Purpose: Antiresorptive therapy use is associated with osteonecrosis of the jaw (ONJ), an infrequent but serious adverse event. Positively adjudicated ONJ in the denosumab (DMAb)…
  • Abstract Number: 324 • ACR/ARHP Annual Meeting 2017

    The Predictors of the Efficacy of Denosumab, a Monoclonal Antibody to RANK Ligand, on Osteoporosis in Rheumatoid Arthritis Patients from Japanese Multicenter Study

    Kyosuke Hattori1, Yuji Hirano1, Yasuhide Kanayama2, Nobunori Takahashi3, Naoki Ishiguro3 and Toshihisa Kojima3, 1Rheumatology, Toyohashi Municipal Hospital, Toyohashi, Japan, 2Orthopaedic Surgery and Rheumatology, Toyota Kosei Hospital, Toyota, Japan, 3Orthopaedic Surgery and Rheumatology, Nagoya University Graduate School of Medicine, Nagoya, Japan

    Background/Purpose: Although early intensive treatment has improved medication of rheumatoid arthritis (RA), treatment for osteoporosis (OP) in RA patient will be more important. Here, we…
  • Abstract Number: 1435 • ACR/ARHP Annual Meeting 2017

    Consistent Inhibition of Joint Destruction By Denosumab in Important Subgroups of Japanese Patients with Rheumatoid Arthritis: Pooled Analysis of Phase 2 and 3 Studies

    Yoshiya Tanaka1, Tsutomu Takeuchi2, Satoshi Soen3, Naoki Ishiguro4, Hisashi Yamanaka5, Toshiyuki Yoneda6, Sakae Tanaka7, Takaya Nitta8, Naoki Okubo9, Harry K. Genant10 and Désirée van der Heijde11, 1University of Occupational and Environmental Health, Kitakyushu, Japan, 2Keio University School of Medicine, Tokyo, Japan, 3Kindai University Nara Hospital, Ikoma, Japan, 4Orthopaedic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan, 5Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, 6Indiana University School of Medicine, Indianapolis, IN, 7Department of Orthopaedic Surgery, Faculty of Medicine, The University of Tokyo, Bunkyo-ku, Japan, 8Daiichi Sankyo Co., Ltd., Tokyo, Japan, 9DaiichiSankyo CO., LTD., Tokyo, Japan, 10University of California, San Francisco, CA, 11Leiden University Medical Center, Leiden, Netherlands

    Background/Purpose: Denosumab is a fully human monoclonal antibody (IgG2 subclass) that inhibits bone resorption by blocking RANKL. Phase 2 (DRIVE) and phase 3 (DESIRABLE) studies…
  • Abstract Number: 1850 • ACR/ARHP Annual Meeting 2017

    Efficacy of Zoledronic Acid and Denosumab in the Treatment of Patients with Low Back Pain and Modic Changes: A Proof of Principle Trial

    Guoqi Cai1, Laura Laslett1, Dawn Aitken2, Andrew Halliday3, Feng Pan2, Petr Otahal1, Deb Speden4, Tania Winzenberg1 and Graeme Jones2, 1Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia, 2Musculoskeletal Unit, Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia, 3Radiology, Royal Hobart Hospital, Hobart, Australia, 4Royal Hobart Hospital, Hobart, Australia

    Background/Purpose: Low back pain (LBP) is a common and debilitating problem. There are currently very limited pharmacological treatments for LBP. Vertebral endplate subchondral bone abnormalities…
  • Abstract Number: 1886 • ACR/ARHP Annual Meeting 2017

    Continued Fracture Risk Reduction after 12 Months of Romosozumab Followed By Denosumab through 36 Months in the Extension of the Phase 3 Fracture Study in Postmenopausal Women with Osteoporosis

    E Michael Lewiecki1, Rajani V Dinavahi2, Marise Lazaretti-Castro3, Peter R Ebeling4, J Adachi5, Akimitsu Miyauchi6, Evelien Gielen7, Cassandra E Milmont2, Cesar Libanati8 and Andreas Grauer2, 1New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, 2Amgen Inc., Thousand Oaks, CA, 3Federal University of São Paulo, São Paulo, Brazil, 4Monash University, Melbourne, Australia, 5McMaster University, Hamilton, ON, Canada, 6Miyauchi Medical Center, Osaka, Japan, 7University Hospitals Leuven, Leuven, Belgium, 8UCB Pharma, Brussels, Belgium

    Background/Purpose: Romosozumab (Romo) is a monoclonal antibody that binds sclerostin with a dual effect, increasing bone formation and decreasing bone resorption. In the primary analysis…
  • Abstract Number: 1887 • ACR/ARHP Annual Meeting 2017

    Ten-Year Continued Nonvertebral Fracture Reduction in Postmenopausal Osteoporosis with Denosumab Treatment

    S Ferrari1, PW Butler2, DL Kendler3, Paul D Miller4, C Roux5, AT Wang2, Rachel B. Wagman2 and EM Lewiecki6, 1Geneva University Hospital, Geneva, Switzerland, 2Amgen Inc., Thousand Oaks, CA, 3University of British Columbia, Vancouver, BC, Canada, 4Colorado Center for Bone Research, Lakewood, CO, 5Paris Descartes University, Paris, France, 6New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM

    Background/Purpose: Treatment with denosumab (DMAb) for 3 years significantly reduces the incidence of nonvertebral fractures (NVFx; Cummings NEJM 2009). While there are limited data describing…
  • Abstract Number: 1888 • ACR/ARHP Annual Meeting 2017

    Effect of Denosumab Compared with Risedronate on Percentage Change in Lumbar Spine Bone Mineral Density at 12 Months in Subgroups of Glucocorticoid-Treated Individuals

    Kenneth Saag1, N Pannacciulli2, P Geusens3, J Adachi4, Eric Lespessailles5, J Malouf6, O Messina7, AT Wang2, Rachel B. Wagman2 and WF Lems8, 1University of Alabama, Birmingham, AL, 2Amgen Inc., Thousand Oaks, CA, 3Maastricht University, Maastricht, Netherlands, 4McMaster University, Hamilton, ON, Canada, 5University Hospital Orleans, Orleans, France, 6Hospital San Pablo, Barcelona, Spain, 7Cosme Argerich Hospital, Buenos Aries, Argentina, 8VU University Medical Centre, Amsterdam, Netherlands

    Background/Purpose: Glucocorticoid (GC)-induced osteoporosis (GIOP) remains the most common secondary cause of osteoporosis. We previously demonstrated that denosumab (DMAb) significantly increased lumbar spine (LS) BMD…
  • Abstract Number: 1889 • ACR/ARHP Annual Meeting 2017

    Safety and Efficacy of Denosumab Among Subjects with Mild-to-Moderate Chronic Kidney Disease (CKD) in the “Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months” Extension Study

    Aaron Broadwell1, Peter R Ebeling2, Edward Franek3, Stefan Goemaere4, Rachel B. Wagman5, Xiang Yin5, Susan Yue5 and Paul D Miller6, 1Rheumatology and Osteoporosis Specialists, Shreveport, LA, 2Monash University, Clayton, Australia, 3Mossakowski Medical Research Centre, Polish Academy of Sciences, Warsaw, Poland, 4Ghent University Hospital, Gent, Belgium, 5Amgen Inc., Thousand Oaks, CA, 6Colorado Center for Bone Research, Lakewood, CO

    Background/Purpose: As renal function may decline with age, it is important to understand the safety and efficacy of therapeutic agents for postmenopausal osteoporosis (PMO) and…
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