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Purpose Trabecular bone score (TBS) is a grey-level textural measurement acquired from dual-energy X-ray absorptiometry lumbar spine images and is a validated index of bone microarchitecture. In 2015, a Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) published a review of the TBS literature, concluding that TBS predicts hip and major osteoporotic fracture, at least partly independent of bone mineral density (BMD) and clinical risk factors. It was also concluded that TBS is potentially amenable to change as a result of pharmacological therapy. Further evidence on the utility of TBS has since accumulated in both primary and secondary osteoporosis, and the introduction of FRAX and BMD T-score adjustment for TBS has accelerated adoption. This position paper therefore presents a review of the updated scientific literature and provides expert consensus statements and corresponding operational guidelines for the use of TBS. Methods An Expert Working Group was convened by the ESCEO and a systematic review of the evidence undertaken, with defined search strategies for four key topics with respect to the potential use of TBS: (1) fracture prediction in men and women; (2) initiating and monitoring treatment in postmenopausal osteoporosis; (3) fracture prediction in secondary osteoporosis; and (4) treatment monitoring in secondary osteoporosis. Statements to guide the clinical use of TBS were derived from the review and graded by consensus using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. Results A total of 96 articles were reviewed and included data on the use of TBS for fracture prediction in men and women, from over 20 countries. The updated evidence shows that TBS enhances fracture risk prediction in both primary and secondary osteoporosis, and can, when taken with BMD and clinical risk factors, inform treatment initiation and the choice of antiosteoporosis treatment. Evidence also indicates that TBS provides useful adjunctive information in monitoring treatment with long-term denosumab and anabolic agents. All expert consensus statements were voted as strongly recommended. Conclusion The addition of TBS assessment to FRAX and/or BMD enhances fracture risk prediction in primary and secondary osteoporosis, adding useful information for treatment decision-making and monitoring. The expert consensus statements provided in this paper can be used to guide the integration of TBS in clinical practice for the assessment and management of osteoporosis. An example of an operational approach is provided in the appendix. Summary This position paper presents an up-to-date review of the evidence base, synthesised through expert consensus statements, which informs the implementation of Trabecular Bone Score in clinical practice.

Globally, one in five men aged >50 years is predicted to experience an osteoporotic fracture. Because of the treatment gap in osteoporosis and the paucity of bone-forming agents for men, new osteoporosis treatments are needed. To evaluate the safety and efficacy of romosozumab in men with osteoporosis. Phase III randomized BRIDGE study (placebo-controlled double-blind study evaluating the efficacy and safety of romosozumab in treating men with osteoporosis; ClinicalTrials.gov identifier, NCT02186171) for 12 months. Thirty-one centers in Europe, Latin America, Japan, and North America. Men aged 55 to 90 years with a baseline bone mineral density (BMD) T-score at the lumbar spine (LS), total hip (TH), or femoral neck of ≤-2.5 or ≤-1.5 with a history of a fragility nonvertebral or vertebral fracture. The subjects were randomized 2:1 to receive romosozumab 210 mg subcutaneously monthly or placebo for 12 months. The primary efficacy endpoint was percentage change from baseline in LS BMD at month 12. In 245 subjects (163 romosozumab, 82 placebo), at month 12, the mean percentage change from baseline in the LS and TH BMD was significantly greater for the romosozumab group than for the placebo group (LS, 12.1% vs 1.2%; TH, 2.5% vs -0.5%; P < 0.001). Adverse events and serious adverse events were balanced between the two groups, with a numerical imbalance in the positively adjudicated cardiovascular serious adverse events [romosozumab, 8 (4.9%) vs placebo, 2 (2.5%)]. Treatment with romosozumab for 12 months increased the spine and hip BMD compared with placebo and was well tolerated in men with osteoporosis.

SummaryThe Risk-stratified Osteoporosis Strategy Evaluation (ROSE) study investigated the effectiveness of a two-step screening program for osteoporosis in women. We found no overall reduction in fractures from systematic screening compared to the current case-finding strategy. The group of moderate- to high-risk women, who accepted the invitation to DXA, seemed to benefit from the program.IntroductionThe purpose of the ROSE study was to investigate the effectiveness of a two-step population-based osteoporosis screening program using the Fracture Risk Assessment Tool (FRAX) derived from a self-administered questionnaire to select women for DXA scan. After the scanning, standard osteoporosis management according to Danish national guidelines was followed.MethodsParticipants were randomized to either screening or control group, and randomization was stratified according to age and area of residence. Inclusion took place from February 2010 to November 2011. Participants received a self-administered questionnaire, and women in the screening group with a FRAX score ≥ 15% (major osteoporotic fractures) were invited to a DXA scan. Primary outcome was incident clinical fractures. Intention-to-treat analysis and two per-protocol analyses were performed.ResultsA total of 3416 fractures were observed during a median follow-up of 5 years. No significant differences were found in the intention-to-treat analyses with 34,229 women included aged 65–80 years. The per-protocol analyses showed a risk reduction in the group that underwent DXA scanning compared to women in the control group with a FRAX ≥ 15%, in regard to major osteoporotic fractures, hip fractures, and all fractures. The risk reduction was most pronounced for hip fractures (adjusted SHR 0.741, p = 0.007).ConclusionsCompared to an office-based case-finding strategy, the two-step systematic screening strategy had no overall effect on fracture incidence. The two-step strategy seemed, however, to be beneficial in the group of women who were identified by FRAX as moderate- or high-risk patients and complied with DXA.

Abstract SummaryTBS algorithm has been updated to account for regional soft tissue noise. In postmenopausal women with osteoporosis, denosumab improved tissue thickness–adjusted TBS vs placebo independently of bone mineral density over 3 years, with the magnitude of changes from baseline or placebo numerically greater than body mass index–adjusted TBS.IntroductionTo evaluate the effect of denosumab on bone microarchitecture assessed by trabecular bone score (TBS) in the FREEDOM study using the updated algorithm that accounts for regional soft tissue thickness (TBSTT) in dual-energy X-ray absorptiometry (DXA) images and to compare percent changes from baseline and placebo with classical body mass index (BMI)–adjusted TBS (TBSBMI).MethodsPostmenopausal women with lumbar spine or total hip bone mineral density (BMD) T score <  − 2.5 and ≥  − 4.0 received placebo or denosumab 60 mg subcutaneously every 6 months. TBSBMI and TBSTT were assessed on lumbar spine DXA scans at baseline and months 1, 12, 24, and 36 in a subset of 279 women (129 placebo, 150 denosumab) who completed the 3-year FREEDOM DXA substudy and rolled over to open-label extension study.ResultsBaseline characteristics were similar between groups. TBSTT in the denosumab group showed numerically greater changes from both baseline and placebo than TBSBMI at months 12, 24, and 36. Denosumab led to progressive increases in BMD (1.2, 5.6, 8.1, and 10.5%) and TBSTT (0.4, 2.3, 2.6, and 3.3%) from baseline to months 1, 12, 24, and 36, respectively. Both TBS changes were significant vs baseline and placebo from months 12 to 36 (p < 0.0001). As expected, BMD and TBSTT were poorly correlated both at baseline and for changes during treatment.ConclusionIn postmenopausal women with osteoporosis, denosumab significantly improved bone microstructure assessed by TBSTT over 3 years. TBSTT seemed more responsive to denosumab treatment than TBSBMI and was independent of BMD.

Currently available anthropometric body composition prediction equations were often developed on small participant samples, included only several measured predictor variables, or were prepared using conventional statistical regression methods. Machine learning approaches are increasingly publicly available and have key advantages over statistical modeling methods when developing prediction algorithms on large datasets with multiple complex covariates. This study aimed to test the feasibility of predicting DXA-measured appendicular lean mass (ALM) with a neural network (NN) algorithm developed on a sample of 576 participants using 10 demographic (sex, age, 7 ethnic groupings) and 43 anthropometric dimensions generated with a 3D optical scanner. NN-predicted and measured ALM were highly correlated (n = 116; R2, 0.95, p < 0.001, non-significant bias) with small mean, absolute, and root-mean square errors (X ± SD, −0.17 ± 1.64 kg and 1.28 ± 1.04 kg; 1.64). These observations demonstrate the application of NN body composition prediction algorithms to rapidly emerging large and complex digital anthropometric datasets. Clinical Trial Registration: NCT03637855, NCT05217524, NCT03771417, and NCT03706612.

•Reduced steady-state methods during 10 min of measurement overestimate the resting energy expenditure (REE).•Interval methods during 10 and 30 min of measurement overestimate the REE.•We recommend 5 min in steady state during 30 min of measurement to estimate the REE. The aim of this study was to test the accuracy of different methods of resting energy expenditure (REE) data analysis using indirect calorimetry (IC) during traditional (30 min) and abbreviated (10 min) protocols. Fifteen women and 15 men (21–34 y of age) completed two consecutive 30-min IC measurements. Body composition was measured using dual-energy x-ray absorptiometry. The reference method for REE analysis was 5 min in steady state (SS) during 30 min (first 5 min discarded). REE measurements were randomized to define a reference or testing method. An interval method was defined using 25, 20, and 15 min (with first 5, 10, and 15 min discarded, respectively), during 30 min, and 5 min (first 5 min discarded) during 10-min intervals. The SS method was defined using 5 min in SS (first 5 min discarded) during 30 min, 5, 4, and 3 min in SS during 10-min (first 5 min discarded) intervals. Interval methods during 30 min and SS and interval methods during 10 min demonstrated large bias with significantly high REEs compared to the reference method (78.8–109.0 kcal/d, all P < 0.001). Testing methods demonstrated large upper limits of agreement between 225.2 and 322.8 kcal/d. No mean differences (P > 0.05), small bias (14.3 kcal/d), and narrow limits of agreement (–125.8 to 154.4 kcal/d) were observed between 5-min SS during 30 min and the reference method. All interval methods and SS methods during 10 min overestimated REE. We recommend using 5-min SS during 30 min. The measurement may be repeated until all participants achieve SS.

Radiofrequency Echographic Multi Spectrometry (REMS) is a radiation-free, portable technology, which can be used for the assessment and monitoring of osteoporosis at the lumbar spine and femoral neck and may facilitate wider access to axial BMD measurement compared with standard dual-energy x-ray absorptiometry (DXA). There is a growing literature demonstrating a strong correlation between DXA and REMS measures of BMD and further work supporting 5-year prediction of fracture using the REMS Fragility Score, which provides a measure of bone quality (in addition to the quantitative measure of BMD). The non-ionising radiation emitted by REMS allows it to be used in previously underserved populations including pregnant women and children and may facilitate more frequent measurement of BMD. The portability of the device means that it can be deployed to measure BMD for frail patients at the bedside (avoiding the complications in transfer and positioning which can occur with DXA), in primary care, the emergency department, low-resource settings and even at home. The current evidence base supports the technology as a useful tool in the management of osteoporosis as an alternative to DXA.

Summary Thyrotoxicosis leads to loss of bone mass. Vitamin D is important to bone health. In this randomized, placebo-controlled trial, we showed that bone restoration did not improve when adding vitamin D supplementation to standard care of Graves’ disease thyrotoxicosis. Bone density and microarchitecture improved markedly with treatment of thyrotoxicosis. Purpose Vitamin D is important to skeletal health and ensuring a replete vitamin D status is recommended. In thyrotoxicosis, bone turnover is increased and bone mass density (BMD) reduced. We examined whether vitamin D supplementation improves bone recovery in thyrotoxicosis caused by Graves’ disease (GD). Methods Using a double-blinded design, hyperthyroid patients with GD were randomized to vitamin D3 70 µg/day (2800 IU) or similar placebo as add-on to antithyroid drugs (ATD). At baseline and 9 months, we measured BMD and bone architecture using DXA and high resolution peripheral quantitative computerized tomography. Bone turnover markers (BTM) were measured at 3 months also. Effect of vitamin D versus placebo and the response to ATD treatment were analyzed using linear mixed modelling. Results Eighty-six GD patients were included (age 41 ± 14 years, 86% females). Compared to placebo, vitamin D3 did not improve BMD or microarchitecture. In response to ATD, BMD increased in the hip by 2% (95%CI: 1–4%). Cortical porosity decreased in tibia (− 7% [95%CI: − 12 to − 2%]) and radius [− 14% [95%CI: − 24 to − 3%]), and trabecular thickness increased (tibia (5% [95%CI: 2 − 9%]) and radius (4% [95%CI: 1–7%]). Changes in BTM, but not thyroid hormones, were associated with changes in BMD by DXA and with changes in the cortical compartment. Conclusion In newly diagnosed GD, 9 months of high dose vitamin D3 supplementation does not offer benefit by improving skeletal health. Treatment of thyrotoxicosis is associated with the recovery of BMD and microarchitecture. Clinicaltrial.gov identifier NCT02384668

SummaryTreatment effects of combining teriparatide and whole-body vibration exercise (WBV) vs teriparatide alone in twelve months were compared using bone mineral density (BMD), bone microarchitecture, and bone turnover markers. We found an increased effect in lumbar spine BMD by adding WBV to teriparatide in postmenopausal osteoporotic women.IntroductionThe parathyroid hormone (PTH) analogue teriparatide is an effective but expensive anabolic treatment for osteoporosis. Whole-body vibration exercise (WBV) has been found to stimulate muscle and bone strength in some studies. Animal data demonstrate a beneficial effect on bone when combining PTH with mechanical loading. The aim of this study was to investigate if combining WBV exercise and teriparatide treatment gives additional beneficial effects on bone compared to teriparatide alone in postmenopausal women with osteoporosis.MethodsThe PaVOS study is a randomized controlled trial where postmenopausal osteoporotic women starting teriparatide 20 μg/day were randomized to WBV + teriparatide or teriparatide alone. WBV consisted of three sessions a week (12 min, including 1:1 ratio of exercise:rest). Bone mineral density (BMD) and bone microarchitecture, bone turnover markers, and sclerostin measurements were obtained. Data were analyzed using a linear mixed regression model with adjustment for baseline values or robust cluster regression in an intention-to-treat (ITT) analysis.ResultsThirty-five women were randomized (17 in teriparatide + WBV group and 18 in teriparatide group). At 12 months, both groups increased significantly in BMD at the lumbar spine. The teriparatide + WBV group increased by (mean ± SD) 8.90% ± 5.47 and the teriparatide group by 6.65% ± 5.51. The adjusted treatment effect of adding WBV to teriparatide was statistically significant at 2.95% [95% CI = 0.14–5.77; P = 0.040]. Markers of bone turnover increased significantly in both groups at three and six months with no significant difference between groups. No other treatment effects were observed in hip BMD, bone microarchitecture parameters, or sclerostin levels in either group.ConclusionTwelve months of WBV and teriparatide had a significant clinically relevant treatment effect in lumbar spine BMD compared to teriparatide alone in postmenopausal osteoporotic women.ClinicalTrials.gov:(NCT02563353).

Summary The EFOPS trial clearly established the positive effect of long-term exercise on clinical low-trauma fractures in postmenopausal women at risk. Bearing in mind that the complex anti-fracture exercise protocols also affect a large variety of diseases of increased age, we strongly encourage older adults to perform multipurpose exercise programs. Introduction Physical exercise may be an efficient option for autonomous fracture prevention during increasing age. The aim of the study was to evaluate the effect of exercise on clinical overall fracture incidence and bone mineral density (BMD) in elderly subjects at risk. Methods In 1998 initially, 137 early-postmenopausal, osteopenic women living in Erlangen-Nuremberg, Germany, were included in the EFOPS trial. Subjects of the exercise group (EG; n  = 86) conducted two supervised group and two home exercise sessions/week while the control group (CG; n  = 51) was requested to maintain their physical activity. Primary study endpoints were clinical overall low-trauma fractures determined by questionnaires, structured interviews, and BMD at the lumbar spine and femoral neck assessed by dual-energy X-ray absorptiometry. Results In 2014, 105 subjects (EG: n  = 59 vs. CG: n  = 46) representing 1680 participant-years were included in the 16-year follow-up analysis. Risk ratio in the EG for overall low-trauma fractures was 0.51 (95 % confidence interval (95 % CI) 0.23 to 0.97, p  = .046), rate ratio was 0.42 (95 % CI 0.20 to 0.86, p  = .018). Based on comparable baseline values, lumbar spine (MV −1.5 %, 95 % CI −0.1 to −2.8 vs. −5.8 %, −3.3 to −7.2 %) and femoral neck (−6.5 %, −5.2 to −7.7 vs. −9.6 %, −8.2 to 11.1 %) BMD decreased in both groups; however, the reduction was more pronounced in the CG ( p  ≤ .001). Conclusion This study clearly evidenced the high anti-fracture efficiency of multipurpose exercise programs. Considering furthermore the favorable effect of exercise on most other risk factors of increasing age, we strongly encourage older adults to perform multipurpose exercise programs.