High Imminent Vertebral Fracture Risk in Subjects With COPD With a Prevalent or Incident Vertebral Fracture

Dort, M.J. van; Geusens, Piet; Driessen, Johanna H M; Romme, Elisabeth A. P. M.; Smeenk, Frank W.J.M.; Wouters, Emiel F.M.; Bergh, Joop van den

doi:10.1002/jbmr.3429

Cited by 18 publications

(20 citation statements)

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“…The consequences of osteoporosis, namely fractures, result in substantial clinical and economic burden among postmenopausal women . After a fracture, the risk of second fracture is five times higher in the next year, and recent fracture and other characteristics such as older age and low bone mineral density (BMD) can put patients at high risk for fracture both over a longer‐term horizon (eg, 10 years), as well as over shorter‐term horizons . However, even in patients in whom there is urgency to treat, there is a large treatment gap in osteoporosis, with only about 20% of patients receiving treatment following a fracture .…”

Section: Introductionmentioning

confidence: 99%

One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions: Results of the FRAME Extension Study

Lewiecki

Dinavahi

Lazaretti‐Castro

et al. 2018

Journal of Bone and Mineral Research

154

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Romosozumab, a humanized monoclonal antibody that binds and inhibits sclerostin, has the dual effect of increasing bone formation and decreasing bone resorption. As previously reported in the pivotal FRActure study in postmenopausal woMen with ostEoporosis (FRAME), women with a T‐score of ≤ –2.5 at the total hip or femoral neck received subcutaneous placebo or romosozumab once monthly for 12 months, followed by open‐label subcutaneous denosumab every 6 months for an additional 12 months. Upon completion of the 24‐month primary analysis period, eligible women entered the extension phase and received denosumab for an additional 12 months. Here, we report the final analysis results through 36 months, including efficacy assessments of new vertebral, clinical, and nonvertebral fracture; bone mineral density (BMD); and safety assessments. Of 7180 women enrolled, 5743 (80%) completed the 36‐month study (2851 romosozumab‐to‐denosumab; 2892 placebo‐to‐denosumab). Through 36 months, fracture risk was reduced in subjects receiving romosozumab versus placebo for 12 months followed by 24 months of denosumab for both groups: new vertebral fracture (relative risk reduction [RRR], 66%; incidence, 1.0% versus 2.8%; p < 0.001), clinical fracture (RRR, 27%; incidence, 4.0% versus 5.5%; p = 0.004), and nonvertebral fracture (RRR, 21%; incidence, 3.9% versus 4.9%; p = 0.039). BMD continued to increase for the 2 years with denosumab treatment in both arms. The substantial difference in BMD achieved through 12 months of romosozumab treatment versus placebo was maintained through the follow‐up period when both treatment arms received denosumab. Subject incidence of adverse events, including positively adjudicated serious cardiovascular adverse events, were overall balanced between groups. In conclusion, in postmenopausal women with osteoporosis, 12 months of romosozumab led to persistent fracture reduction benefit and ongoing BMD gains when followed by 24 months of denosumab. The sequence of romosozumab followed by denosumab may be a promising regimen for the treatment of osteoporosis. © 2018 American Society for Bone and Mineral Research.

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Section: Introductionmentioning

confidence: 99%

One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions: Results of the FRAME Extension Study

Lewiecki

Dinavahi

Lazaretti‐Castro

et al. 2018

Journal of Bone and Mineral Research

154

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“…Of these, 237 subjects were excluded because of various reasons, including scan quality (noise, missing slices, incorrect slice spacing; n = 156); anatomy (could not identify T 1 /vertebral levels, deformation of the spine; n = 14); failure of the method to edit CT scans (slice numbers not in ascending order and/or not starting at 0 or 1, problems with white balance in Matlab, or unclear adapted CT images; n = 60); or use of oral GC at baseline ( n = 7). Additionally, 2 subjects were excluded because of multiple deformations other than VFs (platyspondyly, Scheuermann's disease; for flowchart and characteristics of included and excluded subjects, see van Dort and colleagues). Thus, 1239 subjects were included (999 subjects with and 240 subjects without COPD).…”

Section: Resultsmentioning

confidence: 99%

“…Subjects with respiratory diseases other than COPD were excluded, as well as subjects with an exacerbation requiring treatment in the 4 weeks before enrollment, and subjects using oral glucocorticosteroids (GC) at baseline. Only subjects with complete set of CT scans at baseline, 1‐year, and 3‐year follow‐up were included; subjects with scans of insufficient quality or lack of clear anatomic landmarks to identify vertebrae were not eligible for this study …”

Section: Methodsmentioning

confidence: 99%

“…Subsequently, all sagittal reformats containing the spine were superposed to create simulated lateral X‐ray 2D images using Matlab (version R2013a, MathWorks, Natick, MA, USA). Images were exported in DICOM‐format …”

Section: Methodsmentioning

confidence: 99%

“…VF assessment was described in detail elsewhere . In short, vertebrae were first visually evaluated and were, after exclusion of deformities due to Scheuermann's disease, Schmorl's noduli, or platyspondyly, marked as “VF” or “no VF.” Next, in case of positive evaluation, vertebrae were morphometrically assessed using SpineAnalyzer software (Optasia Medical, Cheadle, UK) .…”

Section: Methodsmentioning

confidence: 99%

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Thoracic Kyphosis on Chest CT Scans Is Associated With Incident Vertebral Fractures in Smokers

Dort

Driessen

Romme

et al. 2019

Journal of Bone and Mineral Research

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Greater kyphosis angles lead to increased loading on vertebral bodies in computational models. However, results about the relationship between severity of kyphosis and incident vertebral fracture (VF) risk have been conflicting. Therefore, the aim of this study was to evaluate associations between 1) prevalent VFs and severity of kyphosis, and 2) severity of kyphosis and incident VF risk in smokers with or without chronic obstructive pulmonary disease (COPD). Former and current smokers with or without COPD were included. CT scans were made at baseline, 1‐year, and 3‐year follow‐up. VFs were evaluated on superposed sagittal CT reconstructions. Kyphosis was measured as the angle between the lines above T4 and below T9 or T12. We included 1239 subjects (mean age 61.3 ± 8.0 years, 61.1% male, 80.6% with COPD), of whom 253 (20.4%) had a prevalent VF and 294 (23.7%) an incident VF within 3 years. Presence, number, and severity of prevalent VFs were associated with a greater kyphosis angle. The mean increase in kyphosis angle within 3 years was small but significantly greater in subjects with incident VFs compared with those without (2.2 ± 4.1 versus 1.2 ± 3.9 degrees, respectively, for T4 to T12 angle, p < 0.001). After adjustment for bone attenuation (BA) and prevalent VFs, baseline kyphosis angle was associated with incident VFs within 1 and 3 years (angle T4 to T12 per +1 SD, hazard ratio [HR] = 1.34 [1.12–1.61] and HR 1.29 [1.15–1.45], respectively). Our data showed that a greater kyphosis angle at baseline was independently associated with increased risk of incident VFs within 1 and 3 years, supporting the theory that greater kyphosis angle contributes to higher biomechanical loads in the spine. © 2019 American Society for Bone and Mineral Research.

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Vertebral bone attenuation in Hounsfield Units and prevalent vertebral fractures are associated with the short-term risk of vertebral fractures in current and ex-smokers with and without COPD: a 3-year chest CT follow-up study

et al. 2019

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Summary CT scans performed to evaluate chronic obstructive pulmonary disease (COPD) also enable evaluation of bone attenuation (BA; a measure of bone density) and vertebral fractures (VFs). In 1239 current/former smokers with ( n = 999) and without ( n = 240) COPD, the combination of BA and prevalent VFs was associated with the incident VF risk. Introduction Chest CT scans are increasingly used to evaluate pulmonary diseases, including COPD. COPD patients have increased risk of osteoporosis and VFs. BA on CT scans is correlated with bone mineral density and prevalent VFs. The aim of this study was to evaluate the association between BA and prevalent VFs on chest CT scans, and the risk of incident VFs in current and former smokers with and without COPD. Methods In participants of the ECLIPSE study with baseline and 1-year and 3-year follow-up CT scans, we evaluated BA in vertebrae T 4 –T 12 and prevalent and incident VFs. Results A total of 1239 subjects were included (mean age 61.3 ± 8.0, 61.1% men, 999 (80.6%) COPD patients). The mean BA was 155.6 ± 47.5 Hounsfield Units (HU); 253 (20.5%) had a prevalent VF and 296 (23.9%) sustained an incident VF within 3 years. BA and prevalent VFs were associated with incident VFs within 1 (per − 1SD HR = 1.38 [1.08–1.76] and HR = 3.97 [2.65–5.93] resp.) and 3 years (per − 1SD HR = 1.25 [1.08–1.45] and HR = 3.10 [2.41–3.99] resp.), while age, sex, body mass index (BMI), smoking status and history, or presence of COPD was not. In subjects without prevalent VFs and BA, and for 1-year incidence, BMI values were associated with incident fractures (1 year, BA per − 1SD HR = 1.52 [1.05–2.19], BMI per SD HR = 1.54 [1.13–2.11]; 3 years, per − 1SD HR = 1.37 [1.12–1.68]). Conclusions On CT scans performed for pulmonary evaluation in (former) smokers with and without COPD, the combination of BA and prevalent VFs was strongly associated with the short-term risk of incident VFs. Electronic supplementary material The online version of this article (10.1007/s00198-019-04977-w) contains supplementary material, which is available to authorized users.

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High Imminent Vertebral Fracture Risk in Subjects With COPD With a Prevalent or Incident Vertebral Fracture

Cited by 18 publications

References 61 publications

One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions: Results of the FRAME Extension Study

One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions: Results of the FRAME Extension Study

Thoracic Kyphosis on Chest CT Scans Is Associated With Incident Vertebral Fractures in Smokers

Vertebral bone attenuation in Hounsfield Units and prevalent vertebral fractures are associated with the short-term risk of vertebral fractures in current and ex-smokers with and without COPD: a 3-year chest CT follow-up study

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