Effects of Two Years of Daily Teriparatide Treatment on BMD in Postmenopausal Women With Severe Osteoporosis With and Without Prior Antiresorptive Treatment

Authors

  • Barbara M Obermayer-Pietsch,

    Corresponding author
    1. Klinische Abteilung Endokrinologie/Nuklearmedizin, Universitätsklinik für Innere Medizin, Medizinische Universität, Graz, Austria
    • Address reprint requests to: Barbara Obermayer-Pietsch, MD, Universitätsklinik für Innere Medizin, Medizinische Universität Graz, Auenbruggerplatz 15, A-8036 Graz, Austria
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    • Dr Obermayer-Pietsch has received travel grants and research support from Eli Lilly and Company. Dr Boonen has received research support from Eli Lilly and Company. Dr Fraser has received an unrestricted educational grant and honoraria from Eli Lilly and Company. Dr Hadji has received travel grants, speaker's honoraria, and consultancy fees from Eli Lilly and Company. Dr McCloskey has received research support and speaker's fees from Eli Lilly and Company. Drs Marin, Barker, and Nickelsen are full-time employees of Eli Lilly and Company. All other authors state that they have no conflicts of interest.

  • Fernando Marin,

    1. Department of Medical Research, Lilly Research Centre, Windlesham, United Kingdom
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  • Eugene V McCloskey,

    1. The WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield, Sheffield, United Kingdom
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  • Peyman Hadji,

    1. Department of Endocrinology, Reproductive Medicine and Osteoporosis; Phillipps University, Marburg, Germany
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  • Jordi Farrerons,

    1. Department of Internal Medicine, Hospital Santa Creu i San Pau, Barcelona, Spain
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  • Steven Boonen,

    1. Leuven University Center for Metabolic Bone Diseases and Division of Geriatric Medicine, Leuven, Belgium
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  • Maurice Audran,

    1. Centre Hospitalier Universitaire, Angers, France
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  • Clare Barker,

    1. Department of Medical Research, Lilly Research Centre, Windlesham, United Kingdom
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  • Athanasios D Anastasilakis,

    1. Hippokration Hospital, Thessaloniki, Greece
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  • William D Fraser,

    1. Unit of Clinical Chemistry, School of Clinical Science, University of Liverpool, United Kingdom
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  • Thomas Nickelsen

    1. Department of Medical Research, Lilly Research Centre, Windlesham, United Kingdom
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  • Preliminary data for this article were presented previously at the 28th Annual Meeting of the American Society for Bone and Mineral Research, September 15–19, 2006, Philadelphia, PA, USA, and at the 7th Annual Meeting of the European Congress on Clinical and Economic Aspects of Osteoporosis, March 28–31, 2007, Porto, Portugal.

Abstract

Previous antiresorptive (AR) treatment may influence the response to teriparatide. We examined BMD response and safety in a subgroup of 503 postmenopausal women with osteoporosis who received teriparatide for 24 mo. Patients were divided into three groups based on their prior AR treatment: treatment-naïve (n = 84); pretreated with no evidence of inadequate treatment response (n = 134); and pretreated showing an inadequate response to AR treatment (n = 285), which was predefined based on the occurrence of fractures, persistent low BMD, and/or significant BMD loss while on therapy. Changes in BMD from baseline were analyzed using mixed model repeated measures. Lumbar spine BMD increased significantly from baseline at 6, 12, 18, and 24 mo in all three groups. The mean gain in spine BMD over 24 mo was greater in the treatment-naïve group (0.095 g/cm2; 13.1%) than in the AR pretreated (0.074 g/cm2; 10.2%; p < 0.005) and inadequate AR responder (0.071 g/cm2; 9.8%; p < 0.001) groups. The corresponding increases in total hip BMD were 3.8%, 2.3%, and 2.3%, respectively. Early decreases in hip BMD in the inadequate AR responder group were reversed by 18 mo of treatment. Increases in BMD between 18 and 24 mo were highly significant. Nausea (13.3%) and arthralgia (11.7%) were the most commonly reported adverse events. Asymptomatic hypercalcemia was reported in 5.0% of patients. Teriparatide treatment for 24 mo is associated with a significant increase in BMD in patients with and without previous AR use. Prior AR treatment modestly blunted the BMD response to teriparatide. Safety was consistent with current prescribing label information.

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