Abaloparatide Effects on Cortical Volumetric BMD and Estimated Strength Indices of Hip Subregions by 3D-DXA in Women With Postmenopausal Osteoporosis

Winzenrieth, Renaud; Humbert, Ludovic; Boxberger, John; Weiss, R. J.; Wang, Y.; Kostenuik, Paul J.

doi:10.1016/j.jocd.2021.11.007

Cited by 10 publications

(18 citation statements)

References 24 publications

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“…Consistent with the preclinical data, a post hoc analysis of hip DXA data from ACTIVE using 3D modeling suggests that previously reported differences in areal BMD between abaloparatide and teriparatide may be due to a greater improvement in cortical volumetric BMD of the total hip [36]. Abaloparatide produced greater increases, compared with teriparatide, in cortical volumetric BMD and corresponding biomechanical parameters of the femoral neck, shaft, and trochanter subregions of the hip which might explain, in part, the lower hip fracture risk for abaloparatide versus teriparatide in the current study [35].…”

Section: Discussionsupporting

confidence: 48%

“…Although information on bone mineral density (BMD) changes was not available from the claims database in this real-world study, abaloparatide treatment in ACTIVE and two subsequent studies in a subset of participants from ACTIVE increased BMD significantly more at the total hip and femoral neck compared to teriparatide [13,35,36]. In both preclinical and clinical studies, teriparatide is associated with increased cortical porosity [37][38][39][40].…”

Section: Discussionmentioning

confidence: 95%

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Comparative effectiveness and cardiovascular safety of abaloparatide and teriparatide in postmenopausal women new to anabolic therapy: A US administrative claims database study

et al. 2022

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Real-world evidence on the comparative effectiveness and safety of abaloparatide versus teriparatide in women with osteoporosis may help inform treatment decisions. Following 18 months of treatment, abaloparatide was comparable to teriparatide for prevention of nonvertebral fractures, resulted in a 22% risk reduction for hip fractures, and demonstrated similar cardiovascular safety. Summary Osteoporotic fracture risk can be reduced with anabolic or antiresorptive medications. In addition to efficacy and safety data from controlled clinical trials, real-world evidence on comparative effectiveness and safety may help inform treatment decisions. Introduction The real-world effectiveness of abaloparatide versus teriparatide on nonvertebral fracture (NVF) incidence and cardiovascular safety during the 19-month period after treatment initiation were evaluated (NCT04974723). Methods Anonymized US patient claims data from Symphony Health, Integrated Dataverse (IDV)®, May 1, 2017 to July 31, 2019, included women aged ≥ 50 years with ≥ 1 prescription of abaloparatide or teriparatide and no prior anabolic therapy. Most were enrolled in commercial and Medicare health plans. Index was the date of the initial prescription dispensed during the identification period. In 1:1 propensity score matched cohorts, time to first NVF following index date, major adverse cardiovascular events (MACE), and MACE + heart failure (HF) were compared between cohorts using a Cox proportional hazards model. Results Propensity score matching yielded 11,616 patients per cohort. Overall median age (interquartile range) was 67 (61, 75) years, and 25.6% had a fracture history. Over 19 months, 335 patients on abaloparatide and 375 on teriparatide had a NVF (hazard ratio [95% confidence interval]: 0.89 [0.77, 1.03]), and 121 and 154 patients, respectively, had a hip fracture [HR (95% CI): 0.78 (0.62, 1.00)]. The MACE and MACE + HF rates were similar between cohorts. Conclusions Following 18 months of treatment, abaloparatide was comparable to teriparatide for prevention of NVF and similar cardiovascular safety was demonstrated between cohorts.

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Section: Discussionsupporting

confidence: 48%

Section: Discussionmentioning

confidence: 95%

Comparative effectiveness and cardiovascular safety of abaloparatide and teriparatide in postmenopausal women new to anabolic therapy: A US administrative claims database study

et al. 2022

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“…17,18 3D-DXA has been used to analyze the effect of osteoporosis drug treatments, including denosumab. 19–22…”

Section: Introductionmentioning

confidence: 99%

“…17,18 3D-DXA has been used to analyze the effect of osteoporosis drug treatments, including denosumab. [19][20][21][22] This study, which focuses on dialysis patients, aimed to (1) investigate the long-term effect of denosumab therapy on the cortical and trabecular compartments and estimated strength indices in the hip regions; (2) assess the effect of denosumab discontinuation on the cortical and trabecular compartments and estimated strength indices in the hip regions; and (3) analyze the 3D spatial distribution of the changes in cortical bone before and after denosumab treatments and after denosumab discontinuation. The study protocol was approved by the Showa University Ethics Committee (H25-40) and was conducted in accordance with the principles of the Declaration of Helsinki.…”

Section: Introductionmentioning

confidence: 99%

Long-Term Effect of Denosumab on Bone Disease in Patients with CKD

Iseri

Mizobuchi

Winzenrieth

et al. 2023

CJASN

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Background The effect of long-term denosumab therapy and of denosumab discontinuation on the cortical bone of the hip regions in dialysis patients has not been studied. Methods This retrospective study investigated the cortical and trabecular compartments and estimated strength indices of the hip region, obtained using 3D-SHAPER software, after a maximum of 5 years of denosumab therapy in 124 dialysis patients. A Wilcoxon signed-rank test was used to identify the differences in each parameter before and after denosumab initiation. Similarly, we investigated the changes in these parameters after denosumab discontinuation in 11 dialysis patients. Results Integral and trabecular volumetric bone mineral densities (BMD) were significantly lower at the start of denosumab therapy than those in 1 year before denosumab initiation. After starting denosumab, areal BMD (median change +7.7% (interquartile range [IQR], +4.6 to +10.6), cortical volumetric BMD (median change +3.4% [IQR, +1.0 to +4.7]), cortical surface BMD (median change +7.1% [IQR, +3.4 to +9.4]), and cortical thickness (median change +3.2% [IQR, +1.8 to +4.9]) showed a significantly higher trend for 3.5 years, which then stabilized at a higher value compared with baseline. A similar trend in the trabecular volumetric BMD (median change +9.8% [IQR, +3.8 to +15.7]) was observed over 2.5 years, with a higher value maintained thereafter. The whole area of the hip region improved after denosumab therapy. Similar trajectories were also found in the estimated strength indices. Conversely, at 1 year after denosumab discontinuation, these 3D parameters and estimated strength indices tended to largely worsen. The lateral aspect of the greater trochanter was the most pronounced location showing volumetric BMD loss. Conclusions The BMD of both cortical and trabecular components in the hip region was significantly higher after starting denosumab therapy. However, these measurements exhibited a trend of declining substantially after the discontinuation of denosumab.

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“…Lately, the 3D-Shaper software has experienced a growing interest in the clinical community. Indeed, 3D-Shaper has recently been used to evaluate different treatment strategies for conditions of skeletal fragility, where especially differential effects of the treatment on cortical and trabecular bone densities were examined (Lewiecki et al, 2022;Winzenrieth et al, 2022). In another initiative, the effect of exercise on femoral neck strength was evaluated using 3D DXAbased FE analysis (O'Rourke et al, 2022).…”

Section: Introductionmentioning

confidence: 99%

2D-3D reconstruction of the proximal femur from DXA scans: Evaluation of the 3D-Shaper software

Dudle

Gugler

Pretterklieber

et al. 2023

Front. Bioeng. Biotechnol.

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Introduction: Osteoporosis is currently diagnosed based on areal bone mineral density (aBMD) computed from 2D DXA scans. However, aBMD is a limited surrogate for femoral strength since it does not account for 3D bone geometry and density distribution. QCT scans combined with finite element (FE) analysis can deliver improved femoral strength predictions. However, non-negligible radiation dose and high costs prevent a systematic usage of this technique for screening purposes. As an alternative, the 3D-Shaper software (3D-Shaper Medical, Spain) reconstructs the 3D shape and density distribution of the femur from 2D DXA scans. This approach could deliver a more accurate estimation of femoral strength than aBMD by using FE analysis on the reconstructed 3D DXA.Methods: Here we present the first independent evaluation of the software, using a dataset of 77 ex vivo femora. We extend a prior evaluation by including the density distribution differences, the spatial correlation of density values and an FE analysis. Yet, cortical thickness is left out of this evaluation, since the cortex is not resolved in our FE models.Results: We found an average surface distance of 1.16 mm between 3D DXA and QCT images, which shows a good reconstruction of the bone geometry. Although BMD values obtained from 3D DXA and QCT correlated well (r2 = 0.92), the 3D DXA BMD were systematically lower. The average BMD difference amounted to 64 mg/cm3, more than one-third of the 3D DXA BMD. Furthermore, the low correlation (r2 = 0.48) between density values of both images indicates a limited reconstruction of the 3D density distribution. FE results were in good agreement between QCT and 3D DXA images, with a high coefficient of determination (r2 = 0.88). However, this correlation was not statistically different from a direct prediction by aBMD. Moreover, we found differences in the fracture patterns between the two image types. QCT-based FE analysis resulted mostly in femoral neck fractures and 3D DXA-based FE in subcapital or pertrochanteric fractures.Discussion: In conclusion, 3D-Shaper generates an altered BMD distribution compared to QCT but, after careful density calibration, shows an interesting potential for deriving a standardized femoral strength from a DXA scan.

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Abaloparatide Effects on Cortical Volumetric BMD and Estimated Strength Indices of Hip Subregions by 3D-DXA in Women With Postmenopausal Osteoporosis

Cited by 10 publications

References 24 publications

Comparative effectiveness and cardiovascular safety of abaloparatide and teriparatide in postmenopausal women new to anabolic therapy: A US administrative claims database study

Comparative effectiveness and cardiovascular safety of abaloparatide and teriparatide in postmenopausal women new to anabolic therapy: A US administrative claims database study

Long-Term Effect of Denosumab on Bone Disease in Patients with CKD

2D-3D reconstruction of the proximal femur from DXA scans: Evaluation of the 3D-Shaper software

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