Effect of once-daily fluticasone furoate/vilanterol versus vilanterol alone on bone mineral density in patients with COPD: a randomized, controlled trial

Background: The relationship between inhaled corticosteroids and bone mineral density (BMD) remains uncertain despite extensive research. Methods: This was an international, multicenter, randomized, double-blind, parallel-group, 3-year noninferiority study. Patients with chronic obstructive pulmonary disease (COPD) (⩾40 years of age; smoking history ⩾10 pack years) and at least one native hip evaluable for BMD were enrolled and randomized 1:1, stratified by sex, to treatment with vilanterol (VI) 25 µg or fluticasone furoate/vilanterol (FF/VI) 100 µg/25 µg. BMD measurements were taken via dual-energy X-ray absorptiometry every 6 months. The primary endpoint was assessment of the noninferiority of change from baseline in total hip BMD per year at the −1% noninferiority level. Change from baseline in BMD at the lumbar spine and BMD measurements by sex were secondary endpoints. Incidences of COPD exacerbations and bone fractures throughout the study were also recorded. Results: Of 283 randomized patients, 170 (60%) completed the study. Noninferiority was demonstrated for FF/VI versus VI with regards to change from baseline in total hip BMD per year, with changes of −0.27% and 0.18%, respectively, and a treatment difference of −0.46% per year [95% confidence interval (CI) −0.97 to 0.06]. The treatment difference for FF/VI versus VI regarding lumbar spine BMD was −0.51% per year (95% CI −1.11 to 0.10). COPD exacerbations and bone fracture rates were similar between treatment groups. Conclusion: FF/VI showed noninferiority to VI for change from baseline in total hip BMD per year, when assessed at the −1% noninferiority margin in a combined sample of men and women with COPD. The reviews of this paper are available via the supplemental material section.

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Reduction in femoral neck and total hip bone mineral density following hospitalisation for diabetes-related foot ulceration

Scientific Reports ◽

10.1038/s41598-021-02233-y ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Marcel M. Nejatian ◽

Salar Sobhi ◽

Blake N. Sanchez ◽

Kathryn Linn ◽

Laurens Manning ◽

...

Keyword(s):

Bone Mineral Density ◽

Lumbar Spine ◽

Femoral Neck ◽

Bone Mineral ◽

Fat Mass ◽

Mineral Density ◽

Contralateral Limb ◽

Foot Ulceration ◽

Total Hip ◽

Hip Bmd

AbstractManagement of diabetes-related foot ulceration (DFU) includes pressure offloading resulting in a period of reduced activity. The metabolic effects of this are unknown. This study aims to investigate changes in bone mineral density (BMD) and body composition 12 weeks after hospitalisation for DFU. A longitudinal, prospective, observational study of 22 people hospitalised for DFU was conducted. Total body, lumbar spine, hip and forearm BMD, and total lean and fat mass were measured by dual-energy X-ray absorptiometry (DXA) during and 12 weeks after hospitalisation for DFU. Significant losses in total hip BMD of the ipsilateral limb (− 1.7%, p < 0.001), total hip BMD of the contralateral limb (− 1.4%, p = 0.005), femoral neck BMD of the ipsilateral limb (− 2.8%, p < 0.001) and femoral neck BMD of the contralateral limb (− 2.2%, p = 0.008) were observed after 12 weeks. Lumbar spine and forearm BMD were unchanged. HbA1c improved from 75 mmol/mol (9.2%) to 64 mmol/mol (8.0%) (p = 0.002). No significant changes to lean and fat mass were demonstrated. Total hip and femoral neck BMD decreased bilaterally 12 weeks after hospitalisation for DFU. Future research is required to confirm the persistence and clinical implications of these losses.

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Bone mineral density and hip structural analysis in type 1 diabetic men

Acta Endocrinologica ◽

10.1530/eje.1.02309 ◽

2007 ◽

Vol 156 (1) ◽

pp. 123-127 ◽

Cited By ~ 27

Author(s):

Tomasz Miazgowski ◽

Slawomir Pynka ◽

Marzena Noworyta-Ziętara ◽

Barbara Krzyzanowska-Świniarska ◽

Robert Pikul

Keyword(s):

Bone Mineral Density ◽

Lumbar Spine ◽

Metabolic Control ◽

Bone Mineral ◽

Microvascular Complications ◽

Mineral Density ◽

Hip Strength ◽

Total Hip ◽

Hip Bmd

Objective: The risk of non-vertebral fractures is increased in men with type 1 diabetes (DM1) but studies have shown only moderately decreased or normal bone mineral density (BMD) in these patients. No previous studies have evaluated hip strength and geometry indices in DM1 patients. This study was therefore designed to characterize associations between BMD, dual X-ray absorptiometry (DXA)-based hip strength indices, metabolic control, and DM1chronic complications. Design and methods: The study was performed on 36 males aged 43.6 ± 5.1 years with long-lasting DM1 and 36 healthy males matched for age, weight, and height. BMD in lumbar spine, total hip, upper and lower part of the femoral neck, hip axis length, cross-sectional area and moment of inertia (CSMI), and glycated hemoglobin (HbA1c) were measured. Results: DM1 men had decreased spine BMD (P < 0.05) and normal total hip BMD in comparison with controls. Hip geometry and strength indices were comparable in both groups. However, M1 men had decreased CSMI and upper femur BMD but these differences did not reach statistical significance (P = 0.06). BMD changes and hip strength parameters did not correlate with HbA1c. Conclusions: Middle-aged DM1 men have decreased lumbar spine BMD, normal hip BMD and normal hip strength indices. These changes are not influenced by metabolic control and presence of chronic microvascular complications.

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Negative Association Between Serum Perfluorooctane Sulfate Concentration and Bone Mineral Density in US Premenopausal Women: NHANES, 2005–2008

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/jc.2013-3409 ◽

2014 ◽

Vol 99 (6) ◽

pp. 2173-2180 ◽

Cited By ~ 22

Author(s):

Lian-Yu Lin ◽

Li-Li Wen ◽

Ta-Chen Su ◽

Pau-Chung Chen ◽

Chien-Yu Lin

Keyword(s):

Bone Mineral Density ◽

Lumbar Spine ◽

Bone Mineral ◽

Biological Significance ◽

Chemical Exposure ◽

Mineral Density ◽

Pfos Concentration ◽

Total Hip ◽

Hip Bmd ◽

The Relationship

Context: Perfluorooctanoic acid (PFOA) and perfluorooctane sulfate (PFOS) are used in a variety of products worldwide. However, the relationship among serum PFOA, PFOS concentration, bone mineral density (BMD), and the risk of fractures has never been addressed. Objectives: The study examined the association among serum PFOA, PFOS concentration, and lumbar spine and total hip BMD in the general US population. Design and Participants: We analyzed data on 2339 adults (aged ≧20 y) from the National Health and Nutrition Examination Survey conducted in 2005–2006 and 2007–2008 to determine the relationship among serum PFOA, PFOS concentration, and total lumbar spine and total hip BMD measured by dual-energy x-ray absorptiometry and history of fractures cross-sectionally. Results: After weighting for sampling strategy, a 1-U increase in the natural log-transformed serum PFOS level was associated with a decrease in total lumbar spine BMD by 0.022 g/cm2 (95% confidence interval −0.038, −0.007; P = .006) in women not in menopause. There was no association among PFOA, PFOS concentration, and self-reported fracture in adults. Conclusion: Serum PFOS concentration is associated with decreased total lumbar spine BMD in women not in menopause. However, the potential biological significance of this effect is marginal and subclinical in the general US population. Further studies are warranted to clarify the causal relationship between perfluorinated chemical exposure and BMD.

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Effect of anastrozole on bone mineral density: 5-year results from the ’Arimidex’, Tamoxifen, Alone or in Combination (ATAC) trial

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.511 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 511-511 ◽

Cited By ~ 22

Author(s):

R. E. Coleman

Keyword(s):

Bone Mineral Density ◽

Lumbar Spine ◽

Bone Loss ◽

Bone Mineral ◽

Treatment Effect ◽

Mineral Density ◽

Total Hip ◽

Slowing Down ◽

Significant Difference ◽

Hip Bmd

511 Background: Since reporting the 1- and 2-year results from the ATAC trial bone sub-protocol, 68-month analysis results from the main ATAC trial have shown that, for postmenopausal women with invasive primary breast cancer, adjuvant treatment with anastrozole results in superior efficacy and tolerability compared with tamoxifen. Here we report 5-year bone mineral density (BMD) results from the monotherapy arms (anastrozole, n=81; tamoxifen, n=86) of the bone sub-protocol. Methods: Lumbar spine and total hip BMD were assessed by dual-energy X-ray absorptiometry at baseline and after 1, 2, and 5 years. Results: The median percentage changes in BMD at 1, 2, and 5 years, respectively, are shown in the table . Percentage changes in BMD from baseline to 5 years showed a statistically significant difference in favor of tamoxifen for both lumbar spine (treatment effect [percentage decrease of BMD on anastrozole relative to tamoxifen] −8.1; 95% confidence intervals [CI] −10.1, −6.1; p<0.0001) and total hip (treatment effect −7.4; 95% CI −9.6, −5.3; p<0.0001). For patients with data at baseline, 2, and 5 years, the rate of loss of lumbar spine BMD in the anastrozole group was significantly less from 2 to 5 years than from baseline to 2 years (mean difference in annual rate of change 0.0113, 95% CI 0.006, 0.017; p=0.0002), but there was no evidence of slowing down in the loss of total hip BMD. Five patients with osteopenia at baseline developed osteoporosis on treatment with anastrozole (4) or tamoxifen (1). No patients with normal BMD at baseline became osteoporotic at 5 years. Conclusions: Significant bone loss occurred throughout the 5 years in the anastrozole group, although there appeared to be a slowing down of the rate of bone loss in years 2–5. Although no patients with normal BMD at baseline had become osteoporotic at 5 years, regular monitoring of BMD and bone protection strategies are likely to be required in patients receiving anastrozole in the presence of pre-existing osteopenia. [Table: see text] [Table: see text]

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Effect of Anastrozole on Bone Mineral Density: 5-Year Results From the Anastrozole, Tamoxifen, Alone or in Combination Trial 18233230

Journal of Clinical Oncology ◽

10.1200/jco.2007.11.0726 ◽

2008 ◽

Vol 26 (7) ◽

pp. 1051-1057 ◽

Cited By ~ 268

Author(s):

Richard Eastell ◽

Judith E. Adams ◽

Robert E. Coleman ◽

Anthony Howell ◽

Rosemary A. Hannon ◽

...

Keyword(s):

Bone Mineral Density ◽

Lumbar Spine ◽

Postmenopausal Women ◽

Bone Mineral ◽

Tolerability Profile ◽

Mineral Density ◽

Primary Analysis ◽

Total Hip ◽

Superior Efficacy ◽

Hip Bmd

Purpose The Arimidex, Tamoxifen, Alone or in Combination (ATAC) trial (median follow-up, 68 months) has shown that adjuvant anastrozole has superior efficacy and better tolerability than tamoxifen. However, anastrozole reduces circulating estrogen, and low estradiol levels are associated with decreased bone mineral density (BMD) and increased fracture risk. It is therefore important to understand the effects of long-term aromatase inhibitor therapy on BMD. Patients and Methods This prospective substudy of the ATAC trial assessed BMD changes in postmenopausal women with invasive primary breast cancer receiving anastrozole (1 mg/d) or tamoxifen (20 mg/d) as adjuvant therapy for 5 years. Lumbar spine and total hip BMD were assessed at baseline and after 1, 2, and 5 years. Results One hundred ninety-seven women from the monotherapy arms of the ATAC trial were recruited onto the bone substudy, and 108 were included in the primary analysis. Among anastrozole-treated patients, there was a decrease in median BMD from baseline to 5 years in lumbar spine (−6.08%) and total hip (−7.24%) compared with the tamoxifen group (lumbar spine, +2.77%; total hip, +0.74%). No patients with normal BMD at baseline became osteoporotic at 5 years. Conclusion Anastrozole is associated with accelerated bone loss over the 5-year treatment period. However, although patients with pre-existing osteopenia are likely to require monitoring and bone-protection strategies, patients with normal BMD would not appear to require monitoring beyond the recommendation for healthy postmenopausal women. The effect of anastrozole on bone should be weighed against its superior efficacy and better tolerability profile versus tamoxifen in the main ATAC trial.

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Dose-dependent effects of inhaled corticosteroids on bone mineral density in postmenopausal women with asthma or COPD: A registry-based cohort study

10.1101/184937 ◽

2017 ◽

Author(s):

Wenjia Chen ◽

Kate M. Johnson ◽

J. Mark FitzGerald ◽

Mohsen Sadatsafavi ◽

William D. Leslie

Keyword(s):

Bone Mineral Density ◽

Lumbar Spine ◽

Femoral Neck ◽

Postmenopausal Women ◽

Bone Mineral ◽

Mineral Density ◽

Cross Sectional ◽

Total Hip ◽

Hip Bmd ◽

Sectional Analysis

ABSTRACTBackgroundThe effect of long-term inhaled corticosteroid (ICS) therapy on the bone health of older adults remains unclear due to its possible impact on bone mineral density (BMD).ObjectiveTo evaluate, cross-sectionally and longitudinally, the impact of ICS use on BMD in postmenopausal women with asthma or chronic obstructive pulmonary disease (COPD).MethodsWe used a population-based bone densitometry registry linked with administrative health data of the province of Manitoba, Canada (1999–2013), to identify women with diagnosed asthma or COPD. ICS use was defined as cumulative dispensed days prior to baseline BMD (cross-sectional analysis), and medication possession ratio (MPR) between two BMD measurements (longitudinal analysis). Results were adjusted for multiple covariates including the underlying respiratory diagnosis and its severity.ResultsIn the cross sectional analysis, compared with non-users, women with the highest tertile of prior ICS exposure had lower baseline BMD at the femoral neck (-0.09 standard deviations [SD] below a healthy young adult, 95% CI: −0.16, −0.02) and total hip (-0.14 SD, 95% CI: −0.22, −0.05), but not at the lumbar spine. Longitudinally, the highest tertile of ICS exposure was associated with a slight decline in total hip BMD relative to non-users (-0.02 SD/year, 95% CI: −0.04, −0.01), with no significant effect at the femoral neck and lumbar spine. Middle and lower tertiles of ICS use had no significant effects.ConclusionHigh exposure to ICS was associated with a small adverse effect on baseline hip BMD and total hip BMD loss in post-menopausal women with asthma or COPD.

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Effects of Teriparatide in Postmenopausal Women with Osteoporosis on Prior Alendronate or Raloxifene: Differences between Stopping and Continuing the Antiresorptive Agent

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/jc.2008-2719 ◽

2009 ◽

Vol 94 (10) ◽

pp. 3772-3780 ◽

Cited By ~ 110

Author(s):

Felicia Cosman ◽

Robert A. Wermers ◽

Christopher Recknor ◽

Karen F. Mauck ◽

Li Xie ◽

...

Keyword(s):

Bone Mineral Density ◽

Lumbar Spine ◽

Femoral Neck ◽

Bone Turnover ◽

Postmenopausal Women ◽

Bone Mineral ◽

Mineral Density ◽

Total Hip ◽

Hip Bmd ◽

Switch Group

Objective: The aim of the study was to assess adding vs. switching to teriparatide 20μg/d in patients on alendronate or raloxifene. Design: We conducted a randomized, open-label trial. Patients and Interventions: Postmenopausal women with osteoporosis on alendronate or raloxifene for at least 18 months added teriparatide (Add groups) or switched to teriparatide (Switch groups) for 18 months. Main Outcome Measures: We measured bone turnover markers (BTM) and bone mineral density (BMD). Results: In the alendronate stratum, increases in BTM were smaller in the Add vs. Switch group [6-month PINP (64 vs. 401%); bone ALP (15 vs. 71%); βCTX (27 vs. 250%); all P < 0.001]. However, at 6 months, total hip BMD increased more in the Add vs. Switch group (1.4 vs. −0.8%; P = 0.002). In the Add vs. Switch group, 18-month BMD increments were higher in lumbar spine (8.4 vs. 4.8%; P = 0.003) and total hip (3.2 vs. 0.9%; P = 0.02), but not in femoral neck (2.7 vs. 2.3%; P = 0.75). In the raloxifene stratum, increases in BTM were also smaller in the Add vs. Switch group [6-month PINP (131 vs. 259%; P < 0.001), bone ALP (31 vs. 44%; P = 0.035), and βCTX (67 vs. 144%; P = 0.001)]. At 6 months, total hip BMD increase was greater in the Add vs. Switch group (1.8 vs. 0.5%; P = 0.028). At 18 months, increases in lumbar spine (9.2 vs. 8.1%), total hip (2.8 vs. 1.8%), and femoral neck (3.8 vs. 2.2%) were not significantly different between groups. Conclusions: In women with osteoporosis treated with antiresorptives, greater bone turnover increases were achieved by switching to teriparatide, whereas greater BMD increases were achieved by adding teriparatide. In patients treated with alendronate or raloxifene, adding teriparatide results in a greater bone mineral density response, and appears to be at least as safe as switching to teriparatide.

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