ACR Meeting Abstracts

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Abstracts tagged "cathepsin k inhibitor"

  • Abstract Number: 1026 • 2016 ACR/ARHP Annual Meeting

    Morphea-like Skin Lesions Reported in the Phase 3 Long-Term Odanacatib Fracture Trial and Extension in Postmenopausal Women with Osteoporosis

    Kenneth G. Saag1, Tobie de Villiers2, Peter Alexandersen3, Heidi Jacobe4, Carrie Kovarik5, Victoria P. Werth6, Albert Leung7, Avani Desai-Merchant8, Julie Mattaliano8 and Deborah Gurner8, 1Department of Medicine, Division of Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA, Birmingham, AL, 2Mediclinic Panorama and Department of Obstetrics & Gynecology, University of Stellenbosch, Cape Town, South Africa, Cape Town, South Africa, 3Center for Clinical and Basic Research, Vejle, Denmark, Ballerup, Denmark, 4Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, TX, 5Department of Dermatology, University of Pennsylvania, Philadelphia, PA, USA, Philadelphia, PA, 6Philadelphia VAMC, Philadelphia, PA, USA, Philadelphia, PA, 7Formerly Merck & Co., Inc., Kenilworth, NJ, USA, Kenilworth, NJ, 8Merck & Co., Inc., Kenilworth, NJ, USA, Kenilworth, NJ

    Background/Purpose: LOFT was a double-blind, placebo-controlled trial. Women ≥65 years with total hip (TH) or femoral neck (FN) bone mineral density (BMD) T-score ≤-2.5, or…
  • 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: 343 • 2015 ACR/ARHP Annual Meeting

    Efficacy of Odanacatib in Postmenopausal Women with Osteoporosis: Subgroup Analyses of Data from the Phase 3 Long-Term Odanacatib Fracture Trial

    Kenneth G. Saag1, Peter Alexandersen2, Claude-Laurent Benhamou3, Nigel Gilchrist4, Johan Halse5, E. Michael Lewiecki6, Kurt Lippuner7, Michael McClung8, Masataka Shiraki9, Carolyn A. DaSilva10, Nadia Verbruggen11, Boyd B. Scott10 and Antonio Lombardi10, 1University of Alabama at Birmingham, Birmingham, AL, 2Center for Clinical and Basic Research, Vejle, Denmark, Ballerup, Denmark, 3Hôpital d’Orléans-la-Source, Orléans, France, Orleans, France, 4The Princess Margaret Hospital, Christchurch, New Zealand, Christchurch, New Zealand, 5Osteoporoseklinikken, Oslo, Norway, Oslo, Norway, 6New Mexico Clinical Research & Osteoporosis Center, Albuquerque, New Mexico, USA, Albuquerque, NM, 7Bern University Hospital, Bern, Switzerland, Bern, Switzerland, 8Oregon Osteoporosis Center, Portland, Oregon, USA, Portland, OR, 9Research Institute and Practice for Involutional Diseases, Nagano, Japan, Nagano, Japan, 10Merck & Co., Inc, Kenilworth, NJ, USA, Kenilworth, NJ, 11MSD Europe Inc., Brussels, Belgium, Brussels, Belgium

    Background/Purpose: Odanacatib (ODN), a selective oral inhibitor of cathepsin K, is in development for the treatment of osteoporosis. In the Phase 3, Long-Term Odanacatib Fracture…
  • 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: 1219 • 2013 ACR/ARHP Annual Meeting

    Phase 3 Fracture Trial Of Odanacatib For Osteoporosis – Baseline Characteristics and Study Design

    Socrates Papapoulos1, Henry G. Bone2, David W. Dempster3, John Eisman4, Susan Greenspan5, Michael McClung6, Toshitaka Nakamura7, Joseph Shih8, Albert Leung9, Arthur Santora10, N. Verbruggen11 and Antonio Lombardi12, 1Leiden University Medical Center, Leiden, Netherlands, 2Michigan Bone and Mineral Clinic, Detroit, MI, 3Regional Bone Center, Helen Hayes Hospital, West Haverstraw, NY, 4The Garvan Institute of Medical Research, Sydney, Australia, 5University of Pittsburgh, Pittsburgh, PA, 6Oregon Osteoporosis Center, Portland, OR, 7University of Occupational & Environmental Health, Fukuoaka, Japan, 8Robert Wood Johnson Medical School, Piscataway, NJ, 9Clinical Research, Merck Sharp and Dohme Corp., Rahway, NJ, 10Merck Sharp & Dohme Corp., Whitehouse Station, NJ, 11MSD Belgium, Brussels, Belgium, 12Merck Sharp and Dohme Corp., Rahway, NJ

    Background/Purpose: Odanacatib is a selective and reversible inhibitor of cathepsin K; a collagenase secreted by osteoclasts, and is currently being evaluated for the treatment of…
  • Abstract Number: 1224 • 2013 ACR/ARHP Annual Meeting

    Prednisone Has No Effect On Odanacatib Pharmacokinetics In Healthy Subjects

    Gene Marcantonio1, Chengcheng Liu2, Stefan Zajic3, Chantal Mahon2, David Hreniuk2, Anish Mehta4, Kate Mostoller2, Denise Morris5, Hongwei Xue5 and S. Aubrey Stoch2, 1Merck & Co., Whitehouse Station, NJ, 2Merck Sharp & Dohme Corp., Whitehouse Station, NJ, 3Merck Sharp & Dohme Corp, Whitehouse Station, NJ, 4Merck Sharp & Dohme Corp.,, Whitehouse Station, NJ, 5Covance, Madison, WI

    Background/Purpose: We evaluated the effect of prednisone, a glucocorticoid believed to induce the CYP P450 enzyme, on the pharmacokinetics of odanacatib, a novel Cathepsin K…
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