The trabecular bone score (TBS) is an index of bone microarchitectural texture calculated from anteroposterior dual-energy X-ray absorptiometry (DXA) scans of the lumbar spine (LS) that predicts fracture risk, independent of bone mineral density (BMD). The aim of this study was to compare the effects of yearly intravenous zoledronate (ZOL) versus placebo (PLB) on LS BMD and TBS in postmenopausal women with osteoporosis. Changes in TBS were assessed in the subset of 107 patients recruited at the Department of Osteoporosis of the University Hospital of Berne, Switzerland, who were included in the HORIZON trial. All subjects received adequate calcium and vitamin D3. In these patients randomly assigned to either ZOL (n ¼ 54) or PLB (n ¼ 53) for 3 years, BMD was measured by DXA and TBS assessed by TBS iNsight (v1.9) at baseline and 6, 12, 24, and 36 months after treatment initiation. Baseline characteristics (mean AE SD) were similar between groups in terms of age, 76.8 AE 5.0 years; body mass index (BMI), 24.5 AE 3.6 kg/m 2 ; TBS, 1.178 AE 0.1 but for LS T-score (ZOL-2.9 AE 1.5 versus PLB-2.1 AE 1.5). Changes in LS BMD were significantly greater with ZOL than with PLB at all time points (p < 0.0001 for all), reaching þ9.58% versus þ1.38% at month 36. Change in TBS was significantly greater with ZOL than with PLB as of month 24, reaching þ1.41 versus-0.49% at month 36; p ¼ 0.031, respectively. LS BMD and TBS were weakly correlated (r ¼ 0.20) and there were no correlations between changes in BMD and TBS from baseline at any visit. In postmenopausal women with osteoporosis, once-yearly intravenous ZOL therapy significantly increased LS BMD relative to PLB over 3 years and TBS as of 2 years. ß
The aim of the present study was to document the changes in bone mineral density (BMD) 1 year after denosumab loss-of-effect following long-term treatment with subcutaneous denosumab 60 mg Q6M during 7 or 10 years and in the absence of any treatment with a bone active substance. All postmenopausal women with osteoporosis who participated to the randomized placebo-controlled FREEDOM core trial and its open-label extension at the University Hospital of Bern, Switzerland, and who accepted to undergo off-treatment follow-up during 1 year after discontinuation, were included (N = 12). After 10 years of denosumab, mean lumbar spine (LS) BMD had increased by 21.2% vs. baseline. One year after discontinuation LS BMD had decreased by - 9.1% vs. Year 10, resulting in a net gain of 10.2% vs. baseline. At total hip (TH) and femoral neck (FN), BMD had increased by 8.3 and 8.1% in Year 10 vs. baseline, respectively. 1 Year after discontinuation, BMD had decreased by - 12.7 and - 11.0% vs. Year 10, respectively, corresponding to net BMD losses of - 5.5 and - 3.8% vs. baseline, respectively. Similar albeit less pronounced changes were observed in those treated with denosumab during 7 years. Stopping denosumab after long-term exposure resulted in BMD losses of large order of magnitude at all measured sites, suggesting that treatment duration may predict the rate and amount of bone lost.
In a real-world setting, APR rates with ZOL and IBN may be higher than reported in randomised controlled trials and may differ by compound, prior BP exposure, and serum 25(OH)D levels.
Background
Areal bone mineral density is predictive for fracture risk. Microstructural bone parameters evaluated at the appendicular skeleton by high-resolution peripheral quantitative computed tomography (HR-pQCT) display differences between healthy patients and fracture patients. With the simple geometry of the cortex at the distal tibial diaphysis, a cortical index of the tibia combining material and mechanical properties correlated highly with bone strength ex vivo. The trabecular bone score derived from the scan of the lumbar spine by dual-energy X-ray absorptiometry (DXA) correlated ex vivo with the micro architectural parameters. It is unknown if these microstructural correlations could be made in healthy premenopausal women.
Methods
Randomly selected women between 20–40 years of age were examined by DXA and HR-pQCT at the standard regions of interest and at customized sub regions to focus on cortical and trabecular parameters of strength separately. For cortical strength, at the distal tibia the volumetric cortical index was calculated directly from HR-pQCT and the areal cortical index was derived from the DXA scan using a Canny threshold-based tool. For trabecular strength, the trabecular bone score was calculated based on the DXA scan of the lumbar spine and was compared with the corresponding parameters derived from the HR-pQCT measurements at radius and tibia.
Results
Seventy-two healthy women were included (average age 33.8 years, average BMI 23.2 kg/m2). The areal cortical index correlated highly with the volumetric cortical index at the distal tibia (R = 0.798). The trabecular bone score correlated moderately with the microstructural parameters of the trabecular bone.
Conclusion
This study in randomly selected premenopausal women demonstrated that microstructural parameters of the bone evaluated by HR-pQCT correlated with the DXA derived parameters of skeletal regions containing predominantly cortical or cancellous bone. Whether these indexes are suitable for better predictions of the fracture risk deserves further investigation.
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