Plenary Poster 29th Australian and New Zealand Bone and Mineral Society Annual Scientific Meeting 2019

Effect of denosumab versus risedronate on cortical and trabecular bone microarchitecture by high resolution peripheral quantitative computed tomography (HR-pQCT) in glucocorticoid-treated individuals (#88)

Piet Geusens 1 , Stefan Goemaere 2 , Nico Pannacciulli 3 , Nancy E Lane 4 , Eric Lespessailles 5 , Osvaldo Messina 6 , Roland Chapurlat 7 , X Yin 3 , Rachel B Wagman 8 , Joop PW van den Bergh 1 , Jeffrey Hassall 8
  1. Maastricht University, Maastricht, The Netherlands
  2. Ghent University Hospital, Ghent, Belgium
  3. Amgen Inc., Thousand Oaks, CA, USA
  4. University of California, Davis, CA, USA
  5. University Hospital Orleans, Orleans, France
  6. Cosme Argerich Hospital, Buenos Aires , Argentina
  7. Hôpital Edouard Herriot, Lyon, France
  8. Amgen Australia, North Ryde, NSW, Australia

Purpose: In a study of patients initiating or continuing GC therapy, areal bone mineral density (aBMD) gains were greater with denosumab (DMAb) vs with risedronate (RIS) at the lumbar spine and total hip at 12 and 24 months. This substudy evaluated the effects of DMAb vs RIS on cortical and trabecular bone microarchitecture by HR-pQCT.

 

Methods: The phase 3, randomized, double-blind, double-dummy, active-controlled study enrolled women and men ≥18 years receiving GC (≥7.5 mg prednisone daily or equivalent) for <3 months (GC-initiating [GC-I]) or ≥3 months (GC-continuing [GC‑C]) before screening. All subjects <50 years had a history of osteoporosis-related (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. Subjects were randomized 1:1 to subcutaneous DMAb 60 mg every 6 months or oral RIS 5 mg daily for 24 months; all were to receive daily calcium (≥1000 mg) and vitamin D (≥800 IU). In a subset, HR-pQCT (XtremeCT I; Scanco) scans of the distal radius and distal tibia were performed at baseline, Month 12, and Month 24. Treatment differences (DMAb–RIS) were estimated with an analysis of covariance (ANCOVA) model.

 

Results: 111 subjects (57 DMAb and 54 RIS) enrolled in the substudy. 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 was not different between DMAb and RIS at either timepoint (Table).

 

Conclusion: DMAb was associated with sustained improvements in cortical bone structure, as assessed by HR‑pQCT of the radius and tibia, as compared with RIS.

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