“You will see an increased porosity in the cortical bone, and I think that is what explains the initial decrease. You’ll also see that it’s kind of catching up [to romosozumab]. This is only a 12-month study, unfortunately. I’m sure if it had been continued for 24 months, there would be an increase in strength because that has been demonstrated in other studies.”
The trial’s comparison of romosozumab versus teriparatide alone also leaves open the question of whether adding teriparatide to bisphosphonate or switching to a combination of teriparatide plus denosumab or teriparatide plus zoledronic acid might have yielded results comparable with romosozumab alone.
Furthermore, The study is not large enough to determine the overall side-effect profile of romosozumab and will have to wait until the larger, ongoing phase III studies are completed, Dr. Langdahl said. In the STRUCTURE study, the overall side effect profile was well balanced between the two groups. More women who received teriparatide developed hypercalcemia, and patients who received romosozumab developed antibodies, although they did not neutralize the agent’s effects.
The study was sponsored by UCB Pharma and Amgen. One investigator is an employee of UCB, and one is an employee of Amgen. Dr. Langdahl reported receiving research grants, consulting fees, and/or honoraria from Amgen, UCB, Eli Lilly, Merck, and Orkla. Most other investigators also reported financial relationships to Amgen and other pharmaceutical companies.