3D modelling of hip DXA scans in postmenopausal women with osteoporosis reveals superior improvements in bone density of romosozumab versus controls

The data were presented along with additional 17 abstracts, at the American Society for Bone and Mineral Research (ASBMR) 2022 Annual Congress, taking place from 9th – 12th September in Austin, Texas, USA.

DXA-based modelling enables estimation of cortical and trabecular bone parameters comparable to QCT measurements and generates outputs to visualize and monitor osteoporosis (OP) treatment. In both analyses, Lewiecki et al. used DXA-based modelling of the hip to assess 3D bone changes and map the distribution of changes in bone parameters over time in patients from FRAME, ARCH and STRUCTURE.

In the first abstract, Lewiecki et al. looked at 3D modelling from hip DXA scans in postmenopausal women with osteoporosis who received oral bisphosphonate therapy for greater than 3 years and ALN for greater than 1 year prior to screening, and were randomized to ROMO or a comparator (STRUCTURE: teriparatide [TPTD]) for 12 months. The analysis found greater increases in CvBMD, Cth, CsBMD and TvBMD from as early as Month 6 following treatment with ROMO vs TPTD, with additional gains observed through to Month 12. The results also showed TPTD treatment led to a loss in CvBMD, Cth and CsBMD.

Another abstract by Lewiecki et al. reported the results of a post-hoc analysis from the FRAME and ARCH studies. Postmenopausal women with osteoporosis were randomized to romosozumab 210 mg monthly (ROMO) or a comparator (FRAME: PBO; ARCH: alendronate [ALN] 70 mg) for 12 months. After 12 months, all patients received denosumab (DMAB) in FRAME or ALN in ARCH. 3D modelling from hip DXA scans found that at Month 12, treatment with ROMO vs PBO in FRAME and ROMO vs ALN in ARCH resulted in greater increases in cortical volumetric bone mineral density (CvBMD), cortical thickness (Cth), cortical surface BMD (CsBMD) and trabecular volumetric BMD (TvBMD).

At month 24, the cumulative gains in CvBMD, Cth, CsBMD and TvBMD were greater in the ROMO/DMAB vs PBO/DMAB sequence (P<0.001) and in the romo aln vs aln aln sequence (p><0.05). this data further corroborates the cosman et al. and mcclung et al. studies that showed greater bmd gains, reduced new vertebral fracture incidence and lower incidence of clinical, non-vertebral and hip fractures with romo dmab treatment, and significant improved bone microarchitecture with romo aln treatment, respectively.

Osteoporosis is the most common chronic metabolic bone disease. Characterised by compromised bone strength, the condition causes approximately 9 million fractures each year. Fragility fractures can result in significant burden on a person’s life, often making everyday activities such as eating, dressing, shopping or driving difficult.

“As people are living longer, the burden of fragility fractures due to osteoporosis requires effective addressing. So we are proud to communicate additional data supporting romosozumab as a bone forming option for postmenopausal women with severe osteoporosis at high risk of fracture,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions & Head of US, UCB. “ASBMR 2022 provides an integral forum for clinicians and scientists around the world to come together and share the latest breakthroughs and innovations and so we at UCB are proud to be participating with a wealth of scientific research this year. Our goal is to ensure osteoporosis care is a priority now and in the future, so we can continue to improve patient outcomes.”