title: Comparative effects of teriparatide and risedronate in glucocorticoid-induced osteoporosis in men: 18-month results of the EuroGIOPs trial.
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.
authors: Sektion Biomedizinische Bildgebung, Klinik für Diagnostische Radiologie, Universitätsklinikum Schleswig-Holstein, Kiel, Germany. glueer@rad.uni‐kiel.de
authors: Claus-C
authors: CC
authors: Glüer
authors: Fernando
authors: F
authors: Marin
authors: Johann D
authors: JD
authors: Ringe
authors: Federico
authors: F
authors: Hawkins
authors: Rüdiger
authors: R
authors: Möricke
authors: Nikolaos
authors: N
authors: Papaioannu
authors: Parvis
authors: P
authors: Farahmand
authors: Salvatore
authors: S
authors: Minisola
authors: Guillermo
authors: G
authors: Martínez
authors: Joan M
authors: JM
authors: Nolla
authors: Christopher
authors: C
authors: Niedhart
authors: Nuria
authors: N
authors: Guañabens
authors: Ranuccio
authors: R
authors: Nuti
authors: Emilio
authors: E
authors: Martín-Mola
authors: Friederike
authors: F
authors: Thomasius
authors: Georgios
authors: G
authors: Kapetanos
authors: Jaime
authors: J
authors: Peña
authors: Christian
authors: C
authors: Graeff
authors: Helmut
authors: H
authors: Petto
authors: Beatriz
authors: B
authors: Sanz
authors: Andreas
authors: A
authors: Reisinger
authors: Philippe K
authors: PK
authors: Zysset
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects; D012968:Etidronic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000378:metabolism; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced* / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000378:metabolism; D011859:Radiography; D000068296:Risedronic Acid; D016103:Spinal Fractures / Q000000981:diagnostic imaging / Q000378:metabolism; D019379:Teriparatide / Q000008:administration & dosage*
chemical_list: D050071:Bone Density Conservation Agents; D005938:Glucocorticoids; D019379:Teriparatide; D000068296:Risedronic Acid; D012968:Etidronic Acid