Researchers Identify Novel Approach to Aid in Osteoporosis Clinical Trials

Total hip bone mineral density (BMD) may be a useful surrogate marker for fracture risk reduction in clinical trials of new osteoporosis treatments, according to findings from a new analysis presented at the American Society for Bone and Mineral Research 2019 Annual Meeting.

To determine whether the surrogate threshold effect for BMD change could establish a new regulatory pathway for osteoporosis medications, the researchers evaluated data of 61,415 participants from 22 clinical trials collected as part of the Foundation for the National Institutes of Health (FNIH) Bone Quality Project.

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The researchers assessed the treatment-related difference in total hip BMD changes—the difference in change between the active and placebo groups at 24 months—and what relationship these measurements had with the observed fracture risk reduction in each trial.

Results showed that the 24-month difference in the change in total hip BMD was 1.7% for vertebral fracture surrogate thresholds, 4.6% for hip fracture surrogate thresholds, and 3.2% for the nonvertebral surrogate thresholds. 

“These analyses identify thresholds of total hip BMD change that predict a reduction in fracture and may be helpful to regulatory agencies if they adopt total hip BMD as a surrogate for fracture risk reduction in clinical trials of new osteoporosis drugs,” the researchers concluded.

—Colleen Murphy

Reference:

Eastell R, Vittinghoff E, Liu L-Y, et al. Surrogate threshold effect: a novel approach for potential approval of new osteoporosis treatments using change in BMD. Study-level analysis from the FNIH Bone Quality Project [abstract #1090]. Presented at: American Society for Bone and Mineral Research 2019 Annual Meeting; September 22, 2019; Orlando, FL.