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Comparative effects of teriparatide and risedronate in glucocorticoid‐induced osteoporosis in men: 18‐month results of the EuroGIOPs trial
Authors:Claus‐C Glüer PhD  Fernando Marin  Johann D Ringe  Federico Hawkins  Rüdiger Möricke  Nikolaos Papaioannu  Parvis Farahmand  Salvatore Minisola  Guillermo Martínez  Joan M Nolla  Christopher Niedhart  Nuria Guañabens  Ranuccio Nuti  Emilio Martín‐Mola  Friederike Thomasius  Georgios Kapetanos  Jaime Peña  Christian Graeff  Helmut Petto  Beatriz Sanz  Andreas Reisinger  Philippe K Zysset
Institution:1. Sektion Biomedizinische Bildgebung, Klinik für Diagnostische Radiologie, Universit?tsklinikum Schleswig‐Holstein, , Kiel, Germany;2. Lilly Research Center, , Windlesham, UK;3. Klinikum Leverkusen, , Leverkusen, Germany;4. Hospital 12 de Octubre, , Madrid, Spain;5. Institut für Pr?ventive Medizin & Klinische Forschung, , Magdeburg, Germany;6. Laboratory for the Research of Musculoskeletal System, University of Athens Medical School, KAT Hospital, , Athens, Greece;7. Policlinico Umberto I, , Roma, Italy;8. Hospital Bellvitge, , Barcelona, Spain;9. Gemeinschaftspraxis, , Heinsberg, Germany;10. Hospital Clinic and Center of Network Biomedical Research in Hepatic and Digestive Diseases, , Barcelona, Spain;11. Policlinico Le Scotte, , Siena, Italy;12. Hospital La Paz, , Madrid, Spain;13. Osteoporose Studiengesellschaft, , Frankfurt, Germany;14. Aristotelion University, , Thessaloniki, Greece;15. Lilly Research Center, , Vienna, Austria;16. Institute for Lightweight Design and Structural Biomechanics, , Vienna, Austria;17. Institute of Surgical Technology and Biomechanics, , Bern, Switzerland
Abstract:Data on treatment of glucocorticoid‐induced osteoporosis (GIO) in men are scarce. We performed a randomized, open‐label trial in men who have taken glucocorticoids (GC) for ≥3 months, and had an areal bone mineral density (aBMD) T‐score ≤ –1.5 standard deviations. Subjects received 20 μg/d teriparatide (n = 45) or 35 mg/week risedronate (n = 47) for 18 months. Primary objective was to compare lumbar spine (L1–L3) BMD measured by quantitative computed tomography (QCT). Secondary outcomes included BMD and microstructure measured by high‐resolution QCT (HRQCT) at the 12th thoracic vertebra, biomechanical effects for axial compression, anterior bending, and axial torsion evaluated by finite element (FE) analysis from HRQCT data, aBMD by dual X‐ray absorptiometry, biochemical markers, and safety. Computed tomography scans were performed at 0, 6, and 18 months. A mixed model repeated measures analysis was performed to compare changes from baseline between groups. Mean age was 56.3 years. Median GC dose and duration were 8.8 mg/d and 6.4 years, respectively; 39.1% of subjects had a prevalent fracture, and 32.6% received prior bisphosphonate treatment. At 18 months, trabecular BMD had significantly increased for both treatments, with significantly greater increases with teriparatide (16.3% versus 3.8%; p = 0.004). HRQCT trabecular and cortical variables significantly increased for both treatments with significantly larger improvements for teriparatide for integral and trabecular BMD and bone surface to volume ratio (BS/BV) as a microstructural measure. Vertebral strength increases at 18 months were significant in both groups (teriparatide: 26.0% to 34.0%; risedronate: 4.2% to 6.7%), with significantly higher increases in the teriparatide group for all loading modes (0.005 < p < 0.015). Adverse events were similar between groups. None of the patients on teriparatide but five (10.6%) on risedronate developed new clinical fractures (p = 0.056). In conclusion, in this 18‐month trial in men with GIO, teriparatide showed larger improvements in spinal BMD, microstructure, and FE‐derived strength than risedronate.
Keywords:BONE MINERAL DENSITY  BONE MICROSTRUCTURE  FINITE ELEMENT ANALYSIS  GLUCOCORTICOID‐INDUCED OSTEOPOROSIS  HIGH RESOLUTION QUANTITATIVE COMPUTED TOMOGRAPHY  MALE OSTEOPOROSIS  VERTEBRAL FRACTURE
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