osteoporosis and safety Archives - ACR Meeting Abstracts

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…
Abstract Number: 1027 • ACR/ARHP Annual Meeting 2016
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 • ACR/ARHP Annual Meeting 2016
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 • ACR/ARHP Annual Meeting 2015
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 • ACR/ARHP Annual Meeting 2014
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 • ACR/ARHP Annual Meeting 2014
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…

Abstracts tagged "osteoporosis and safety"

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

Odanacatib Efficacy and Safety in Postmenopausal Women with Osteoporosis: 5-Year Data from the Extension of the Phase 3 Long-Term Odanacatib Fracture Trial

Safety of Denosumab in Postmenopausal Osteoporosis and in Cancer and Bone Metastase Treatment: A Systematic Review and Meta-Analysis

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

Odanacatib Anti-Fracture Efficacy and Safety in Postmenopausal Women with Osteoporosis: Results from the Phase III Long-Term Odanacatib Fracture Trial

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