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Abaloparatide-SC improves trabecular microarchitecture as assessed by trabecular bone score (TBS): a 24-week randomized clinical trial.

ABSTRACT: In a phase 2 trial of 222 postmenopausal women with osteoporosis aged 55 to 85 years randomized to one of three different doses of abaloparatide-SC, subcutaneous teriparatide, or placebo for 24 weeks, abaloparatide-SC resulted in improvements in skeletal microarchitecture as measured by the trabecular bone score. INTRODUCTION:Subcutaneous abaloparatide (abaloparatide-SC) increases total hip and lumbar spine bone mineral density and reduces vertebral and non-vertebral fractures. In this study, we analyzed the extent to which abaloparatide-SC improves skeletal microarchitecture, assessed indirectly by trabecular bone score (TBS). METHODS:This is a post hoc analysis of a phase 2 trial of 222 postmenopausal women with osteoporosis aged 55 to 85 years randomized to abaloparatide-SC (20, 40, or 80 ?g), subcutaneous teriparatide (20 ?g), or placebo for 24 weeks. TBS was measured from lumbar spine dual X-ray absorptiometry (DXA) images in 138 women for whom the DXA device was TBS software compatible. Assessments were made at baseline, 12 and 24 weeks. Between-group differences were assessed by generalized estimating equations adjusted for relevant baseline characteristics, and a pre-determined least significant change analysis was performed. RESULTS:After 24 weeks, TBS increased significantly by 2.27, 3.14, and 4.21% versus baseline in participants on 20, 40, and 80 ?g abaloparatide-SC daily, respectively, and by 2.21% in those on teriparatide (p?

SUBMITTER: Bilezikian JP

PROVIDER: S-EPMC5818587 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Abaloparatide-SC improves trabecular microarchitecture as assessed by trabecular bone score (TBS): a 24-week randomized clinical trial.

Bilezikian J P JP Hattersley G G Fitzpatrick L A LA Harris A G AG Shevroja E E Banks K K Leder B Z BZ Zanchetta J R JR Hans D D

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA 20171122 2

In a phase 2 trial of 222 postmenopausal women with osteoporosis aged 55 to 85 years randomized to one of three different doses of abaloparatide-SC, subcutaneous teriparatide, or placebo for 24 weeks, abaloparatide-SC resulted in improvements in skeletal microarchitecture as measured by the trabecular bone score.<h4>Introduction</h4>Subcutaneous abaloparatide (abaloparatide-SC) increases total hip and lumbar spine bone mineral density and reduces vertebral and non-vertebral fractures. In this st ...[more]

PMID: 29167971

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Project description:BACKGROUND:Lumbar spine TBS, a texture index derived from lumbar spine dual-energy x-ray absorptiometry (DXA) images, enhances fracture prediction. No studies to date have studied a broad range of clinical variables to determine which patients might experience the greatest benefit from the use of TBS. METHODS:Using the Manitoba BMD Registry, we identified 37,176 subjects with baseline DXA, FRAX®-based fracture probability, lumbar spine TBS, and minimum 5?years of observation. Subgroups considered were based on sex, age, body mass index (BMI), prior fracture, chronic obstructive lung disease (COPD), high alcohol use, rheumatoid arthritis (RA), high glucocorticoid use, osteoporotic femoral neck T-score, number of comorbidities, diabetes, secondary osteoporosis, and prior osteoporosis treatment. Non-traumatic major osteoporotic fractures (MOF, n?=?3741) and hip fractures (HF, n?=?1008) were identified using population-based health services data. We analyzed baseline TBS using analysis of covariance (ANCOVA). FRAX-adjusted hazard ratios (HR) per SD reduction in TBS were estimated and tested for interactions. Categorical net reclassification improvement (NRI) was estimated using fixed FRAX-based intervention cut-offs. RESULTS:Adjusted baseline TBS was significantly lower (p???0.001) for women (-4.2%), osteoporotic hip T-score (-4.0%), COPD (-2.8%), diabetes (-2.6%), high alcohol use (-2.3%), prior fracture (-2.2%), glucocorticoid use (-1.5%), RA (-0.9%) and secondary osteoporosis (-0.8%), whereas recent osteoporosis therapy was associated with greater TBS (+1.5%). HRs per SD reduction in TBS for fracture prediction were larger for age?<?65 vs 65+ (MOF p-interaction?=?0.004, HF p-interaction?<?0.001), without vs with prior fracture (MOF p-interaction?=?0.003, HF p-interaction?=?0.048), without vs with glucocorticoid use (HF p-interaction?=?0.029), lower vs higher comorbidity score (HF p-interaction?<?0.001), and without vs with osteoporosis treatment (MOF p-interaction?=?0.005). NRI for using the TBS adjustment to FRAX in all subjects was 1.2% for MOF (p?=?0.002) and 1.7% for HF (p?=?0.016). NRI was greater in subjects age?<?65 y (MOF:1.7%, HF:5.6%), no prior fracture (HF: 2.4%), non-osteoporotic T-score (HF: 3.0%), and high glucocorticoid use (MOF: 3.9%). CONCLUSION:TBS is sensitive to the effects of multiple risk factors for fracture. TBS-adjusted fracture risk assessment resulted in significant improvements for multiple subgroups.

Project description:This study aimed to better define the role of heel-QUS in fracture prediction. Our results showed that heel-QUS predicts fracture independently of FRAX, BMD, and TBS. This corroborates its use as a case finding/pre-screening tool in osteoporosis management.IntroductionQuantitative ultrasound (QUS) characterizes bone tissue based on the speed of sound (SOS) and broadband ultrasound attenuation (BUA). Heel-QUS predicts osteoporotic fractures independently of clinical risk factors (CRFs) and bone mineral density (BMD). We aimed to investigate whether (1) heel-QUS parameters predict major osteoporotic fractures (MOF) independently of the trabecular bone score (TBS) and (2) the change of heel-QUS parameters over 2.5 years is associated with fracture risk.MethodsOne thousand three hundred forty-five postmenopausal women from the OsteoLaus cohort were followed up for 7 years. Heel-QUS (SOS, BUA, and stiffness index (SI)), DXA (BMD and TBS), and MOF were assessed every 2.5 years. Pearson's correlation and multivariable regression analyses were used to determine associations between QUS and DXA parameters and fracture incidence.ResultsDuring a mean follow-up of 6.7 years, 200 MOF were recorded. Fractured women were older, more treated with anti-osteoporosis medication; had lower QUS, BMD, and TBS; higher FRAX-CRF risk; and more prevalent fractures. TBS was significantly correlated with SOS (0.409) and SI (0.472). A decrease of one SD in SI, BUA or SOS increased the MOF risk by (OR(95%CI)) 1.43 (1.18-1.75), 1.19 (0.99-1.43), and 1.52 (1.26-1.84), respectively, after adjustment for FRAX-CRF, treatment, BMD, and TBS. We found no association between the change of QUS parameters in 2.5 years and incident MOF.ConclusionHeel-QUS predicts fracture independently of FRAX, BMD, and TBS. Thus, QUS represents an important case finding/pre-screening tool in osteoporosis management. The change in QUS over time was not associated with future fractures, making it inappropriate for patient monitoring.

Project description:Adequate dietary calcium (Ca) intake is essential for bone accretion, peak bone mass (PBM) attainment, bone quality and strength during the mammalian growth period. Severe Ca deficiency during growing age results in secondary hyperparathyroidism (SHPT) and poor bone quality and strength. However, the impact of moderate Ca deficiency during rats early growth period on bone health and the reversibility with supplementing calcium later in adult life remains unclear. Female Sprague-Dawley (SD) rats (postnatal 28th day, P28) were initiated either with a moderate calcium-deficient diet (MCD, 0.25% w/w Ca) or a control diet (0.8% w/w Ca, control group) till P70. Thereafter, MCD rats were continued either with MCD diet or supplemented with calcium diet (0.8% w/w Ca, calcium supplemented group, CaS) till P150. Another group (control rats) were fed 0.8% w/w Ca containing diet from P28 till P150. MCD group, as compared to the control group, had significantly reduced serum ionized Ca and procollagen type 1 N-terminal propeptide (P1NP) at P70 while no significant change was observed in serum corrected Ca, inorganic phosphate (P), alkaline phosphatase (ALP), 25-hydroxy vitamin D [25(OH)D], intact parathyroid hormone (iPTH), and urinary C-terminal telopeptide of collagen 1 (CTX-1), Ca, and P. Femoral and tibial metaphysis in MCD rats had significantly reduced linear growth, cortical and trabecular volumetric BMD (vBMD), trabecular microarchitecture (BV/TV%, trabecular thickness, separation and number, structural model index and connectivity density), cortical thickness, and bone stiffness despite the absence of secondary hyperparathyroidism (SHPT). Continued MCD at P70-P150 results in persistence of compromised bone strength while calcium supplementation (CaS group) improved all the parameters related to bone strength and microarchitecture. Our results indicate that uncorrected moderate/subclinical calcium deficiency in growing rats can result in poor bone quality and strength despite the absence of SHPT. This finding could have relevance in children with poor calcium intake in childhood and adolescence.

Dataset Information

Abaloparatide-SC improves trabecular microarchitecture as assessed by trabecular bone score (TBS): a 24-week randomized clinical trial.

Publications

Abaloparatide-SC improves trabecular microarchitecture as assessed by trabecular bone score (TBS): a 24-week randomized clinical trial.

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