Oral Virtual Presentation (Virtual only) ESA-SRB-ANZBMS 2021

Romosozumab (Romo) treatment lowers the incidence of new vertebral fractures (Vfx) across all fracture severity grades among women with postmenopausal osteoporosis (PMO) (#225)

Jeffrey Hassall 1 , Robert Feldman 2 , Mary Oates 3 , Thierry Thomas 4 , Polyzois Makras 5 , Franz Jakob 6 , Bente Langdahl 7 , Wenjing Yang 3 , Maria Rojeski 3 , Cesar Libanati 8
  1. Amgen Australia, Sydney, NSW, Australia
  2. Senior Clinical Trials, Inc, Laguna Hills, CA, USA
  3. Amgen Inc, Thousand Oaks, CA, USA
  4. Department of Rheumatology, Hôpital Nord, CHU Saint-Etienne, Saint-Etienne , France
  5. Department of Endocrinology & Diabetes, 251 Hellenic Air Force General Hospital, Athens, Greece
  6. University of Würzburg, Wuerzburg, Germany
  7. The Department of Endocrinology and Diabetes, Aarhus University Hospital, Aarhus, Denmark
  8. UCB, Brusseles, Belgium

We assessed the incidence of new VFx by Genant severity grade in the Romo vs placebo (Pbo) or alendronate (ALN) arms of the FRAME and ARCH studies, respectively.

The incidence of new VFx was significantly lower among patients who received Romo during the 12-month double-blind treatment phase in both studies. Over 12 months, the incidence of new VFx was 0.5% Romo vs 1.8% Pbo (P<0.001) in FRAME and 3.2% Romo vs 5.0% ALN (P=0.008) in ARCH. Over 24 months, the incidence of new VFx was 0.6% Romo→DMAb vs 2.5% Pbo→DMAb (P<0.001) in FRAME and 4.1% Romo→ALN vs 8.0% ALN→ALN (P<0.001) in ARCH. Fewer new VFx were observed in the Romo arm of both studies across all fracture severity grades. Specifically, in FRAME, the incidence of mild VFx was 0.2% Romo vs 0.4% Pbo over 12 months and 0.2% Romo→DMAb vs 0.6% Pbo→DMAb over 24 months; the incidence of moderate VFx was 0.1% Romo vs 0.9% Pbo over 12 months and 0.2% Romo→DMAb vs 1.4% Pbo→DMAb over 24 months; and the incidence of severe VFx was 0.2% Romo vs 0.5% Pbo over 12 months and 0.2% Romo→DMAb vs 0.6% Pbo→DMAb over 24 months. Similarly, in ARCH, the incidence of mild VFx was 0.5% Romo vs 1.0% ALN over 12 months and 0.4% Romo→ALN vs 1.4% ALN→ALN over 24 months; the incidence of moderate VFx was 1.3% Romo vs 2.1% ALN over 12 months and 1.8% Romo→ALN vs 3.4% ALN→ALN over 24 months; and the incidence of severe VFx was 1.5% Romo vs 1.9% ALN over 12 months and 1.9% Romo→ALN vs 3.3% ALN→ALN over 24 months. 

In conclusion, Romo administered over 12 months resulted in reductions in VFx across all fracture severity grades compared with Pbo and ALN; the treatment effect continued after patients transitioned to an antiresorptive.