OP0080 EFFECT OF DENOSUMAB VERSUS RISEDRONATE ON CORTICAL AND TRABECULAR BONE MICROARCHITECTURE BY HIGH RESOLUTION PERIPHERAL QUANTITATIVE COMPUTED TOMOGRAPHY (HR-PQCT) IN GLUCOCORTICOID-TREATED INDIVIDUALS
Authors: Piet Geusens, Stefan Goemaere, Nicola Pannacciulli, Nancy Lane, Eric Lespessailles, Osvaldo Messina, Roland Chapurlat, Xiang Yin, Rachel Wagman, Joop van den Bergh
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> In a study of patients initiating or continuing GC, 12 and 24 months gains in lumbar spine and total hip areal bone mineral density (aBMD) were greater with DMAb vs RIS.<sup>1,2</sup> <h3>Objectives</h3> Evaluate the effects of DMAb vs RIS on cortical and trabecular bone. <h3>Methods</h3> Phase 3, double-blind, double-dummy, active-controlled study randomised women and men ≥18 years, receiving GC (≥7.5 mg prednisone daily or equivalent) for &lt;3 (GC-initiating [GC-I]) or ≥3 months (GC-continuing [GC–C]), to DMAb 60 mg every 6 months or RIS 5 mg daily for 24 months. Subjects &lt;50 years had a history of osteoporosis (OP) fracture. GC-C subjects ≥50 years had lumbar spine, total hip or femoral neck BMD T–score ≤–2.0; or T-score ≤–1.0 with history of OP fracture. All subjects were to receive daily calcium (≥1000 mg) and vitamin D (≥800 IU). In a subset, HR-pQCT scans of the distal radius and distal tibia were performed at baseline and Months 12 and 24. Treatment differences (DMAb–RIS) were estimated using analysis of covariance (ANCOVA). <h3>Results</h3> The substudy enrolled 111 subjects (57 DMAb, 54 RIS). DMAb was associated with significantly greater increases than RIS in cortical thickness, total volumetric BMD (vBMD) and cortical vBMD at the radius and tibia at 12 and 24 months, and in trabecular vBMD at the radius at 12 months and tibia at 24 months (Table). Change in cortical porosity did not differ between DMAb and RIS (Table). Percentage Change From Baseline and Treatment Difference in vBMD and Cortical Microarchitecture <h3>Conclusion</h3> Compared with RIS, DMAb was associated with sustained improvements in cortical bone structure, assessed by HR–pQCT of the radius and tibia. It remains to be confirmed whether increased cortical thickness with DMAb is associated with improved bone strength in GIOP. These results further support DMAb as a treatment for GC-treated patients at increased fracture risk. <h3>References</h3> [1] Saag KG, et al. Lancet Diabetes Endocrinol. 2018;6(6) [2] Saag KG, et al. Ann Rheum Dis. 2018;77 (Suppl 2) <h3>Acknowledgement</h3> This study was funded by Amgen Inc. <h3>Disclosure of Interests</h3> Piet Geusens Grant/research support from: Research support, consultant and/or speaker fees from: Pfizer, Abbott, Eli Lilly, Amgen, MSD, Roche, UCB, BMS, Novartis, Will-Pharma, Grant/research support from: Pfizer, Abbott, Lilly, Amgen, MSD, Will, Bio Minerals and Roche, Consultant for: Research support, consultant and/or speaker fees from: Pfizer, Abbott, Eli Lilly, Amgen, MSD, Roche, UCB, BMS, Novartis, Will-Pharma, Speakers bureau: Research support, consultant and/or speaker fees from: Pfizer, Abbott, Eli Lilly, Amgen, MSD, Roche, UCB, BMS, Novartis, Will-Pharma, Speakers bureau: Pfizer, Abbott, Lilly, Amgen, MSD, Will, Bio Minerals and Roche, Stefan Goemaere Grant/research support from: Grants/research funding from Amgen, UCB., Speakers bureau: Speakers' bureau for Amgen., Nicola Pannacciulli Shareholder of: Amgen Inc. stockholder., Employee of: Amgen Inc. employee at the time of the study., Nancy Lane Consultant for: Samumed, LLC, Eric Lespessailles Grant/research support from: Grants/research support from Amgen, Eli Lily, MSD, UCB., Consultant for: Consultant for Amgen, Expanscience, Eli Lilly, MSD, UCB., Osvaldo Messina Consultant for: Consultant for Eli Lily, Amgen, Pfizer., Speakers bureau: Speakers' bureau for Eli Lily, Amgen, Pfizer., Roland Chapurlat Grant/research support from: Grants/research support from Amgen, Roche-Chugai, MSD., Consultant for: Consultant for Amgen, UCB, Pfizer, Bristol-Myers Squibb, Sandoz, Radius., Speakers bureau: Speakers fees for Eli Lily, Pfizer, Abbvie, MSD, Janssen-Cilag., Xiang Yin Shareholder of: Amgen Inc. stockholder., Employee of: Amgen Inc. employee at the time of the study., Rachel Wagman Shareholder of: Amgen Inc. stockholder., Employee of: Amgen Inc. employee., Joop van den bergh Grant/research support from: Grants/research support from Eli Lily, Sanofi, Amgen.