Oral Presentation ANZBMS-MEPSA-ANZORS 2022

The proportion of patients who reach the BMD surrogate threshold effect on romosozumab: a post hoc analysis of the randomised FRAME and ARCH phase 3 trials (#24)

Jeffrey Hassall 1 , R. Chapurlat 2 , J. van den Bergh 3 , S. H. Ralston 4 , S. Ferrari 5 , M. McClung 6 , M. Lorentzon 6 7 8 , P. Makras 9 , M. Lewiecki 10 , T. Matsumoto 11 , J. Timoshanko 12 , Z. Wang 13 , C. Libanati 14
  1. Amgen Australia, Sydney, NSW, Australia
  2. INSERM UMR 1033, University Claude Bernard, Lyon, France
  3. VieCuri Medisch Centrum, Venlo, Netherlands
  4. Centre for Genomic and Experimental Medicine, MRC Institute for Genetics and Cancer, University of Edinburgh, Edinburgh, UK
  5. Geneva University Hospital, Geneva, Switzerland
  6. Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia
  7. Sahlgrenska Osteoporosis Centre, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden
  8. 7Geriatric Medicine, Region Västra Götaland, Sahlgrenska University Hospital, , Mölndal, Sweden
  9. 251 Hellenic Air Force & VA General Hospital, Athens, Greece
  10. New Mexico Clinical Research & Osteoporosis Center, Albuquerque, New Mexico, USA
  11. Tokushima University, Tokushima , Japan
  12. UCB Pharma, Slough, UK
  13. Amgen Inc, Thousand Oaks, CA, USA
  14. UCB, Brusseles, Belgium

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Objective(s): The FNIH-ASBMR SABRE project1 defined the bone mineral density (BMD) surrogate threshold effect (STE) required to predict a significant reduction in fracture (fx) at the study level. STEs in the FNIH-ASBMR SABRE project were calculated using difference in BMD percentage change at 24 months (M) between active and placebo (PBO).1 In practice, a more clinically relevant measure is whether patients’ (pts’) BMD has improved with treatment from their own baseline (BL) values. This post hoc analysis of data from FRAME (NCT01575834) and ARCH (NCT01631214) assessed the percentage of pts achieving the established FNIH STE thresholds1 with romosozumab (Romo) or alendronate (ALN) at 12M and 24M when compared to their own BMD values at BL.2,3

Materials and Methods: Postmenopausal women with osteoporosis were randomised to Romo 210mg monthly (QM) or comparator (FRAME: PBO QM; ARCH: alendronate [ALN] 70mg QW) for 12M). After 12M all pts received ALN in ARCH or denosumab (DMAB) in FRAME. Here, we report the proportion of pts that achieved total hip BMD percentage changes at 12M and 24M that meet STEs for vertebral, nonvertebral, hip and any fx risk reduction (observed case), without comparison to PBO.

Results: The table displays the percentage of patients achieving BMD changes from BL corresponding to the STEs for each fracture category.

Conclusion(s): Within 12M of treatment with Romo, most patients achieved the FNIH-SABRE STEs for any reduction in fx risk. At both 12 and 24M, higher proportions of patients met the STEs with Romo compared to ALN for all fx types.

References: 1. Eastell, R. JBMR 2021; Epub; 2. Cosman F. NEJM 2016;375:1532–431; 3. Saag K. NEJM 2017;377:1417–27.