McClung MR, et al. - The impact of denosumab on trabecular bone score (TBS) and the relationship amongst TBS and bone mineral density (BMD) in FREEDOM were investigated in this study. The current study showed that the denosumab significantly improved TBS independently of BMD in postmenopausal women with osteoporosis.

Methods

• In this study, postmenopausal women with lumbar spine or total hip BMD T-score <-2.5 and -4.0 or higher at both sites received placebo or denosumab 60 mg subcutaneously every 6 months.
• TBS indices were determined from DXA scans at baseline and months 12, 24, and 36 in a subset of 285 women (128 placebo, 157 denosumab) who had TBS values at baseline and ≥1 postbaseline visit.

Results

• The outcome revealed that the baseline characteristics were comparable between treatment groups; mean (SD) lumbar spine BMD T-score was -2.79 (0.64), and mean (standard deviation [SD]) TBS was 1.200 (0.101) overall.
• In the placebo group, BMD and TBS increased by ≤ 0.2% or reduced from baseline at each visit.
• In the denosumab group, progressive increases from baseline at 12, 24, and 36 months were seen for BMD (5.7, 7.8, and 9.8%) and TBS (1.4, 1.9, and 2.4%).
• Percentage changes in TBS were statistically significant compared with baseline (p < 0.001) and placebo (p ≤ 0.014).
• TBS was largely unrelated to BMD, regardless of treatment, either at baseline or for annual changes from baseline (all r² ≤ 0.06).