Erratum to: Odanacatib for the treatment of postmenopausal osteoporosis: development history and design and participant characteristics of LOFT, the Long-Term Odanacatib Fracture Trial
Summary Odanacatib is a cathepsin K inhibitor investigated for the treatment of postmenopausal osteoporosis. Phase 2 data indicate that 50 mg once weekly inhibits bone resorption and increases bone mineral density, with only a transient decrease in bone formation. We describe the background, design and participant characteristics for the phase 3 registration trial. Introduction Odanacatib (ODN) is a selective cathepsin K inhibitor being evaluated for the treatment of osteoporosis. In a phase 2 trial, ODN 50 mg once weekly reduced bone resorption while preserving bone formation and progressively increased BMD over 5 years. We describe the phase III LongTerm ODN Fracture Trial (LOFT), an event-driven, randomized, blinded placebo-controlled trial, with preplanned interim analyses to permit early termination if significant fracture risk reduction was demonstrated. An extension was planned, with participants remaining on their randomized treatment for up to 5 years, then transitioning to open-label ODN. Methods The three primary outcomes were radiologically determined vertebral, hip, and clinical non-vertebral fractures. Secondary end points included clinical vertebral fractures, BMD, bone turnover markers, and safety and tolerability, including bone histology. Participants were women, 65 years or older, with a BMD T-score ≤−2.5 at the total hip (TH) or femoral neck (FN) or with a prior radiographic vertebral fracture and a T-score ≤−1.5 at the TH or FN. They were This study was registered with clinicaltrials.gov with registration number NCT00529373. Electronic supplementary material The online version of this article (doi:10.1007/s00198-014-2944-6) contains supplementary material, which is available to authorized users. H. G. Bone (*) Michigan Bone & Mineral Clinic, Detroit, MI, USA e-mail: hgbone.md@att.net D. W. Dempster Columbia University, New York, NY, USA J. A. Eisman Garvan Institute of Medical Research, University of Notre Dame Australia, St Vincent’s Hospital and UNSWAustralia, Sydney, Australia S. L. Greenspan University of Pittsburgh, Pittsburgh, PA, USA M. R. McClung Oregon Osteoporosis Center, Portland, OR, USA T. Nakamura University of Occupational and Environmental Health, Kitakyushu, Japan S. Papapoulos Leiden University Medical Center, Leiden, Netherlands W. J. Shih Robert Wood Johnson Medical School, Piscataway, NJ, USA A. Rybak-Feiglin :A. C. Santora :N. Verbruggen :A. T. Leung : A. Lombardi Merck Sharp and Dohme Corp., Whitehouse Station, NJ, USA H. G. Bone The Osteoporosis Center at St. Luke’s Hospital, Chesterfield, MO, USA Osteoporos Int (2015) 26:699–712 DOI 10.1007/s00198-014-2944-6