Romosozumab Improves Microarchitecture as Assessed by Tissue Thickness-Adjusted Trabecular Bone Score in Postmenopausal Women with Osteoporosis.

Bone mineral density (BMD) is only one of several bone strength determinants affected by osteoporosis therapies. Trabecular Bone Score (TBS), a gray-level texture index determined from lumbar spine (LS) dual-X-ray absorptiometry scans, is an indirect measure of bone microarchitecture independent of and complementary to BMD and clinical risk factors. In the ARCH study, monthly subcutaneous romosozumab 210 mg for 12 months followed by 24-month open-label weekly oral alendronate 70 mg (romosozumab-to-alendronate) significantly reduced fracture risk compared to 36-month alendronate alone in postmenopausal women with osteoporosis and prior fracture.

Asia-pacific consensus on osteoporotic fracture prevention in postmenopausal women with low bone mass or osteoporosis but no fragility fractures.

Postmenopausal women are at significant risk for osteoporotic fractures due to their rapid bone loss. Half of all postmenopausal women will get an osteoporosis-related fracture over their lifetime, with 25% developing a spine deformity and 15% developing a hip fracture. By 2050, more than half of all osteoporotic fractures will occur in Asia, with postmenopausal women being the most susceptible.

A retrospective observational study of osteoporosis management after a fragility fracture in primary care.

Unlabelled: In many countries, osteoporosis is predominantly managed by primary care physicians; however, management after a fragility fracture has not been widely investigated. We describe osteoporosis care gaps in a real-world patient cohort. Our findings help inform initiatives to identify and overcome obstacles to effective management of patients after fragility fracture.

Romosozumab and antiresorptive treatment: the importance of treatment sequence.

Unlabelled: To evaluate whether treatment sequence affects romosozumab response, this analysis reviewed studies where romosozumab was administered before or following an antiresorptive (alendronate or denosumab). Initial treatment with romosozumab followed by an antiresorptive resulted in larger increases in bone mineral density of both hip and spine compared with the reverse sequence.

Introduction: Teriparatide followed by an antiresorptive increases bone mineral density (BMD) more than using an antiresorptive first.

Denosumab in the Treatment of Osteoporosis: 10 Years Later: A Narrative Review.

The fully human monoclonal antibody denosumab was approved for treatment of osteoporosis in 2010 on the basis of its potent antiresorptive activity, which produces clinically meaningful increases in bone mineral density (BMD) and reduces fracture risk at key skeletal sites. At that time, questions remained regarding the long-term safety and efficacy of this receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor; and with clinical experience, new questions have arisen regarding its optimal use. Here, we examine these questions through the lens of data from the FREEDOM trial program and other studies to determine where denosumab fits in the osteoporosis treatment landscape.

Distribution of Prevalent and Incident Vertebral Fractures and Their Association with Bone Mineral Density in Postmenopausal Women in the Teriparatide Versus Risedronate VERO Clinical Trial.

Vertebral fractures (VFx) occur most frequently in the mid-thoracic and thoraco-lumbar regions, which experience the highest mechanical loading along the spine. The prevalence and incidence of VFx by their location and severity, and their relationship with bone mineral density (BMD), are seldom reported in randomized clinical trial cohorts. The VERO trial randomized 1360 postmenopausal women with at least two moderate or one severe VFx to receive either teriparatide or risedronate for up to 24 months.

Favorable skeletal benefit/risk of long-term denosumab therapy: A virtual-twin analysis of fractures prevented relative to skeletal safety events observed.

Antiresorptive therapies reduce fracture risk; however, long-term bone turnover inhibition may raise concerns about rare, but serious, skeletal adverse events-atypical femoral fracture (AFF) and osteonecrosis of the jaw (ONJ). Denosumab, a fully human monoclonal antibody against RANKL, has demonstrated sustained low vertebral and nonvertebral fracture rates with low skeletal adverse event rates in the 3-year FREEDOM trial and its 7-year Extension (in which all subjects received open-label denosumab). In this analysis, we aimed to estimate fractures prevented relative to skeletal adverse events observed with 10 years of denosumab therapy.

The Effects of Home Exercise in Older Women With Vertebral Fractures: A Pilot Randomized Controlled Trial.

Background: Regular exercise is advocated in osteoporosis guidelines to prevent fractures. Few studies have evaluated the effect of exercise on functional performance, posture, and other outcomes that are important to patients after vertebral fractures.

Objective: This pilot study will explore the effect of home exercise versus control on functional performance, posture, and patient-reported outcome measures.

The association between trunk muscle endurance, balance and falls self-efficacy in women with osteoporotic vertebral fractures: an exploratory analysis from a pilot randomized controlled trial.

Background: Trunk muscle endurance may be associated with balance and falls self-efficacy for people with osteoporosis. However, all previous studies have examined trunk muscle strength rather than endurance.

Purpose: To explore the relationships between trunk muscle endurance and standing balance and falls self-efficacy for women with vertebral fractures.

Repeating Measurement of Bone Mineral Density when Monitoring with Dual-energy X-ray Absorptiometry: 2019 ISCD Official Position.

Bone mineral density (BMD) can be measured at multiple skeletal sites using various technologies to aid clinical decision-making in bone and mineral disorders. BMD by dual-energy X-ray absorptiometry (DXA) has a critical role in predicting risk of fracture, diagnosis of osteoporosis, and monitoring patients. In clinical practice, DXA remains the most available and best validated tool for monitoring patients.

Are osteoporotic vertebral fractures or forward head posture associated with performance-based measures of balance and mobility?

Unlabelled: The main objective of this study was to explore whether vertebral fracture characteristics or posture is independently associated with physical performance. Posture was significantly associated with physical performance but fracture characteristics were not, suggesting posture should be the focus of physical performance variance.

Purpose: The main objective of this study was to explore whether vertebral fracture characteristics (number, severity, location) or occiput-to-wall distance (OWD) is independently associated with physical performance.

Western Osteoporosis Alliance Clinical Practice Series: Treat-to-Target for Osteoporosis.

Patients often start treatment to reduce fracture risk because of a bone mineral density T-score consistent with osteoporosis (≤ -2.5). Others with a T-score above -2.

Further Nonvertebral Fracture Reduction Beyond 3 Years for Up to 10 Years of Denosumab Treatment.

Context: Evidence for further nonvertebral fracture (NVF) reductions with long-term antiresorptive therapy in osteoporosis is lacking.

Objective: To evaluate NVF risk reduction in subjects receiving ≤10 years of denosumab treatment.

Design: Phase 3, randomized, placebo-controlled, 3-year Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) trial (NCT00089791) and its open-label 7-year extension (NCT00523341).

Exploring the association between number, severity, location of fracture, and occiput-to-wall distance.

Unlabelled: This study of women with a suspected vertebral fracture determined the association between vertebral fracture characteristics and posture. The number of fractures was associated with posture. Severity of fracture was associated with posture when adjusting for pain.

Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial.

Purpose: Using data from the 2-year, randomized, double-dummy VERO trial, we examined the changes in 25-hydroxy-vitamin D (25[OH]D) concentrations over time, and whether the fracture risk reduction of teriparatide versus risedronate varies by baseline 25(OH)D sufficiency category.

Methods: Postmenopausal women with established osteoporosis received subcutaneous daily teriparatide 20 μg or oral weekly risedronate 35 mg, with concomitant 500-1000 mg of elemental calcium and 400-800 IU/day of vitamin D supplements. Fracture endpoints were analyzed by predefined subgroups of 25(OH)D insufficient and sufficient patients.

Effects of teriparatide on hip and upper limb fractures in patients with osteoporosis: A systematic review and meta-analysis.

In randomized clinical trials (RCTs) with teriparatide, the number of patients with incident hip fractures was small and insufficiently powered to show statistically significant differences between groups. We, therefore, conducted a systematic review and meta-analysis of the efficacy of teriparatide in the reduction of hip and upper limb fractures in women and men with osteoporosis. A comprehensive search of databases until 22 November 2017 was conducted for RCTs of at least 6-month duration that reported non-spine fractures (hip, humerus, forearm, wrist), either as an efficacy or safety endpoint.

Effects of Teriparatide Compared with Risedronate on the Risk of Fractures in Subgroups of Postmenopausal Women with Severe Osteoporosis: The VERO Trial.

The 2-year, randomized, double-blind, active-controlled fracture endpoint VERO study included postmenopausal women with established osteoporosis, who had at least 2 moderate or 1 severe baseline vertebral fractures (VFx), and bone mineral density (BMD) T-score ≤-1.5. Patients were treated with either s.

Score Distributions of the Balance Outcome Measure for Elder Rehabilitation (BOOMER) in Community-Dwelling Older Adults With Vertebral Fracture.

Background And Purpose: We sought to evaluate the Balance Outcome Measure for Elder Rehabilitation (BOOMER) in community-dwelling women 65 years and older with vertebral fracture and to describe score distributions and potential ceiling and floor effects.

Methods: This was a secondary data analysis of baseline data from the Build Better Bones with Exercise randomized controlled trial using the BOOMER. A total of 141 women with osteoporosis and radiographically confirmed vertebral fracture were included.

Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial.

Background: No clinical trials have compared osteoporosis drugs with incident fractures as the primary outcome. We compared the anti-fracture efficacy of teriparatide with risedronate in patients with severe osteoporosis.

Methods: In this double-blind, double-dummy trial, we enrolled post-menopausal women with at least two moderate or one severe vertebral fracture and a bone mineral density T score of less than or equal to -1·50.

Remodeling- and Modeling-Based Bone Formation With Teriparatide Versus Denosumab: A Longitudinal Analysis From Baseline to 3 Months in the AVA Study.

There has been renewed interest of late in the role of modeling-based formation (MBF) during osteoporosis therapy. Here we describe early effects of an established anabolic (teriparatide) versus antiresorptive (denosumab) agent on remodeling-based formation (RBF), MBF, and overflow MBF (oMBF) in human transiliac bone biopsies. Postmenopausal women with osteoporosis received subcutaneous teriparatide (n = 33, 20 μg/d) or denosumab (n = 36, 60 mg once/6 months), open-label for 6 months at 7 US and Canadian sites.

10 years of denosumab treatment in postmenopausal women with osteoporosis: results from the phase 3 randomised FREEDOM trial and open-label extension.

Background: Long-term safety and efficacy of osteoporosis treatment are important because of the chronic nature of the disease. We aimed to assess the long-term safety and efficacy of denosumab, which is widely used for the treatment of postmenopausal women with osteoporosis.

Methods: In the multicentre, randomised, double-blind, placebo-controlled, phase 3 FREEDOM trial, postmenopausal women aged 60-90 years with osteoporosis were enrolled in 214 centres in North America, Europe, Latin America, and Australasia and were randomly assigned (1:1) to receive 60 mg subcutaneous denosumab or placebo every 6 months for 3 years.