Abstracts tagged "osteoporosis and safety"

Abstract Number: 1889 • 2017 ACR/ARHP Annual Meeting
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…
Abstract Number: 1027 • 2016 ACR/ARHP Annual Meeting
Odanacatib Efficacy and Safety in Postmenopausal Women with Osteoporosis: 5-Year Data from the Extension of the Phase 3 Long-Term Odanacatib Fracture Trial
Michael R. McClung¹, Bente Langdahl², Socrates Papapoulos³, Kenneth G. Saag⁴, Henry Bone⁵, Douglas P. Kiel⁶, Kurt Lippuner⁷, Toshitaka Nakamura⁸, Ian Reid⁹, Norman Heyden¹⁰, Carolyn DaSilva¹⁰, Boyd B. Scott¹⁰, Rachid Massaad¹¹, Keith D. Kaufman¹⁰, S. Aubrey Stoch¹⁰, Arthur Santora¹⁰, Deborah Gurner¹⁰ and Antonio Lombardi¹⁰, ¹Oregon Osteoporosis Center, Portland, OR, USA, Portland, OR, ²Aarhus University Hospital, Aarhus, Denmark, Aarhus, Denmark, ³Leiden University Medical Center, Leiden, The Netherlands, Leiden, Netherlands, ⁴University of Alabama at Birmingham, Birmingham, AL, ⁵Michigan Bone & Mineral Clinic, Detroit, MI, USA and The Osteoporosis Center at St. Luke's Hospital, Chesterfield, MO, USA, Detroit, MI, ⁶Institute for Aging Research, Institute for Aging Research, Hebrew Senior Life, Harvard Medical School, Boston, MA, USA, Boston, MA, ⁷Bern University Hospital, Bern, Switzerland, Bern, Switzerland, ⁸University of Occupational and Environmental Health, Fukuoka, Japan, Fukuoaka, Japan, ⁹University of Auckland, Auckland, New Zealand, Auckland, New Zealand, ¹⁰Merck & Co., Inc., Kenilworth, NJ, USA, Kenilworth, NJ, ¹¹MSD Europe Inc., Brussels, Belgium, Brussels, Belgium
Background/Purpose: Long-Term Odanacatib Fracture Trial [Women 65 years of age with BMD T-score ≤–2.5 at total hip (TH) or femoral neck (FN), or with radiographic…
Abstract Number: 330 • 2016 ACR/ARHP Annual Meeting
Safety of Denosumab in Postmenopausal Osteoporosis and in Cancer and Bone Metastase Treatment: A Systematic Review and Meta-Analysis
Marlène Aubailly¹, Bernard Combe², Cécile Gaujoux-Viala³, Cédric Lukas⁴, Jacques Morel⁵ and Hélène Che¹, ¹rheumatology, CHU Lapeyronie, University of Montpellier, France, ²Département Rhumatologie, Hôpital Lapeyronie, Montpellier, France, ³CHU Nîmes, University of Montpellier, France, ⁴Rheumatology, CHU Lapeyronie and EA2415, Montpellier University, University of Montpellier, France, ⁵Rheumatology, Department of Rheumatology, Montpellier University Hospital, Montpellier, France
Background/Purpose: Denosumab is a RANK ligand antibody and the first biologic agent used for the treatment of post-menopausal osteoporosis (OP) and prevention of bone metastases…
Abstract Number: 347 • 2015 ACR/ARHP Annual Meeting
Safety Observations with 3 Years of Denosumab Exposure: Comparison Between Subjects Who Received Denosumab during the Pivotal 3-Year Trial and Subjects Who Crossed over to Denosumab during the Extension
NB Watts¹, JP Brown², S Papapoulos³, EM Lewiecki⁴, DL Kendler⁵, P Dakin⁶, RB Wagman⁶, A Wang⁶, NS Daizadeh⁶, S Smith⁶ and HG Bone⁷, ¹Mercy Health, Cincinnati, OH, ²Laval University and CHU de Québec (CHUL) Research Centre, Québec City, QC, Canada, ³Leiden University Medical Center, Leiden, Netherlands, ⁴New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, ⁵University of British Columbia, Vancouver, BC, Canada, ⁶Amgen Inc., Thousand Oaks, CA, ⁷Michigan Bone and Mineral Clinic, Detroit, MI
Background/Purpose: Denosumab (DMAb) is approved for the treatment of postmenopausal women with osteoporosis at increased risk for fracture. In the pivotal 3-year FREEDOM trial comparing…
Abstract Number: 2268 • 2014 ACR/ARHP Annual Meeting
Odanacatib Anti-Fracture Efficacy and Safety in Postmenopausal Women with Osteoporosis: Results from the Phase III Long-Term Odanacatib Fracture Trial
Michael R. McClung¹, Bente Langdahl², Socrates Papapoulos³, Kenneth G. Saag⁴, Silvano Adami⁵, Henry G. Bone⁶, Tobias de Villiers⁷, Douglas P. Kiel⁸, Annie Kung⁹, Prasanna Kumar¹⁰, Sung-Kil Lim¹¹, Xu Ling¹², Kurt Lippuner¹³, Carlos Mautalen¹⁴, Toshitaka Nakamura¹⁵, Jean-Yves Reginster¹⁶, Ian R. Reid¹⁷, José Adolfo Rodríguez-Portales¹⁸, Christian Roux¹⁹, Jesus Walliser²⁰, Nelson B. Watts²¹, José R. Zanchetta²², Cristiano A.F. Zerbini²³, Andrea Rybak-Feiglin²⁴, Dosinda Cohn²⁴, Carolyn A. DaSilva²⁴, Rachid Massaad²⁵, Arthur Santora²⁴, Boyd B. Scott²⁴, Nadia Verbruggen²⁵, Albert Leung²⁶ and Antonio Lombardi²⁴, ¹Oregon Osteoporosis Center, Portland, OR, ²Aarhus University Hospital, Aarhus, Denmark, ³Leiden University Medical Center, Leiden, Netherlands, ⁴Immunology & Rheumatology, The University of Alabama at Birmingham, Birmingham, AL, ⁵Rheumatology Department, University of Verona, Verona, Italy, ⁶Michigan Bone and Mineral Clinic, Detroit, MI, ⁷Stellenbosch University, Stellenbosch, South Africa, ⁸Institute for Aging Research, Hebrew Senior Life, Harvard Medical School, Boston, MA, ⁹University of Hong Kong, Pokfulam, Hong Kong, China, ¹⁰Bangalore Diabetes Centre, Bangalore, India, ¹¹Yonsei University, Seoul, South Korea, ¹²Peking Union Medical College Hospital, Beijing, China, ¹³Bern University Hospital, Bern, Switzerland, ¹⁴Centro de Osteopatías Médicas, Buenos Aires, Argentina, ¹⁵University of Occupational & Environmental Health, Fukuoaka, Japan, ¹⁶CHU-Centre Ville, Policliniques BRULL, Liege, Belgium, ¹⁷Department of Medicine, University of Auckland, Auckland, New Zealand, ¹⁸Pontificia Universidad Católica de Chile, Santiago, Chile, ¹⁹Paris Descartes University, Cochin Hospital, Paris, France, ²⁰Bone Metabolism Clinic, Hospital Angeles del Pedregal, Mexico City, Mexico, ²¹Mercy Health Osteoporosis and Bone Health Services, Cincinnati, OH, ²²IDIM Instituto de Investigaciones Metabolicas, Buenos Aires, Argentina, ²³Centro Paulista de Investigações Clinicas, São Paulo, Brazil, ²⁴Merck Sharp and Dohme Corp., Rahway, NJ, ²⁵MSD Europe Inc., Brussels, Belgium, ²⁶Clinical Research, Merck Sharp and Dohme Corp., Rahway, NJ
Background/Purpose: Odanacatib (ODN), a selective oral inhibitor of cathepsin K, is in development for the treatment of osteoporosis. The Phase III Long-Term Odanacatib Fracture Trial…
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…

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