Idea Transcript
ABSTRACT PRESENTATIONS THURSDAY CONCURRENT SESSION #1 S-1. Odanacatib Efficacy and Safety in Postmenopausal Women with Osteoporosis: 5-Year Data from the Extension of the Phase 3 Long-term Odanacatib Fracture Trial (LOFT)
Michael R. McClung1, Bente Langdahl2, Socrates Papapoulos3, Kenneth G. Saag4, Henry Bone5,6, Douglas P. Kiel7, Kurt Lippuner8, Toshitaka Nakamura9, Ian Reid10, Norman Heyden 11, Carolyn DaSilva11, Boyd B. Scott 11, Rachid Massaad 12, Keith D. Kaufman11, S. Aubrey Stoch11, Arthur Santora11, Deborah Gurner11, Antonio Lombardi11. 1Oregon Osteoporosis Center, Portland, OR; 2Aarhus University Hospital, Aarhus, Denmark; 3Leiden University Medical Center, Leiden, Netherlands; 4 University of Alabama at Birmgham, Birmingham, AL; 5Michigan Bone & Mineral Clinic, Detroit, MI; 6The Osteoporosis Center at St. Luke’s Hospital, Chesterfield, MO; 7 Institute for Aging Research, Hebrew Senior Life, Harvard Medical School, Boston, MA; 8Bern University Hospital, Bern, Switzerland; 9University of Occupational and Environmental Health, Fukuoka, Japan; 10University of Auckland, Auckland, New Zealand; 11Merck & Co., Inc., Kenilworth, NJ; 12MSD Europe, Inc., Brussels, Belgium Objective: Odanacatib (ODN) is a selective oral inhibitor of cathepsin K in development for the treatment of osteoporosis. The randomized, double-blind, placebo (PBO)controlled, event-driven, Phase 3 Fracture Trial (Long-Term Odanacatib Fracture Trial [LOFT]; NCT00529373) evaluated efficacy and safety of ODN in postmenopausal women with osteoporosis. In a planned double-blind extension to LOFT, eligible patients continued on their originally assigned treatment for up to 5 years. We present efficacy and safety data for the entire 5-year double-blind period. Design: Women ≥65 years of age with BMD T-score ≤–2.5 at total hip (TH) or femoral neck (FN), or with radiographic vertebral fracture (VFx) and T-score ≤–1.5 at TH or FN, were randomized (1:1) to ODN 50 mg/week or PBO. All received vitamin D3 (5600 IU/week) and calcium as required. Endpoints included morphometric VFx, hip fracture, non-VFx, clinical VFx, and safety and tolerability. Specific adverse events (AEs) were adjudicated. Results: Of 16,071 patients (8043 ODN, 8028 PBO) in LOFT, 12,290 (6092 ODN, 6198 PBO) completed the study. Among these, 8,257 (4297 ODN, 3960 PBO) who were eligible and consented entered the extension and 6,047 (3432 ODN, 2615 PBO) completed it. Mean (SD) age at randomization was 72.8 (5.3) years, 46.5% had prior VFx, and mean BMD T-scores were lumbar spine (LS) –2.7, TH –2.4, and FN –2.7. Mean (SD) follow-up was approximately 44 (18) months. Compared with PBO, ODN treatment over 5 years resulted in relative risk reductions of 52% for morphometric VFx, 48% for hip fracture, 26% for non-VFx, and 67% for clinical VFx (all p