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The first biosimilar approved for the treatment of osteoporosis: results of a comparative pharmacokinetic/pharmacodynamic study.
Takács, I, Jókai, E, Kováts, DE, Aradi, I
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. 2019;(3):675-683
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Abstract
UNLABELLED To demonstrate the clinical comparability between RGB-10 (a biosimilar teriparatide) and the originator, a comparative pharmacokinetic trial was conducted. The study was successful in establishing bioequivalence. Marketing authorisation for RGB-10 (Terrosa®) was granted by the European Medicines Agency in 2017. INTRODUCTION Teriparatide, the first bone anabolic agent, is the biologically active fragment of human parathyroid hormone. The imminent patent expiry of the originator will open the door for biosimilars to enter the osteology market, thereby improving access to a highly effective, yet prohibitively expensive therapy. METHODS Subsequent to establishing comparability on the quality and non-clinical levels between RGB-10, a biosimilar teriparatide, and its reference product (Forsteo®), a randomised, double-blind, 2-way cross-over comparative study (duration: four days) was conducted in 54 healthy women (ages: 18 to 55 years) to demonstrate the pharmacokinetic/pharmacodynamic (PK/PD) equivalence and comparable safety of these products. Extents of exposure (AUC0-tlast) and peak exposure (Cmax), as measured by means of ELISA, were evaluated as co-primary PK endpoints, and serum calcium levels, as measured using standard automated techniques, were assessed for PD effects. Safety was monitored throughout the study. RESULTS The 94.12% CIs for the ratio of the test to the reference treatments, used due to the two-stage design (85.20-98.60% and 85.51-99.52% for AUC0-tlast and Cmax, respectively), fell within the 80.00-125.00% acceptance range. The calcium PD parameters were essentially identical with geometric mean ratios (GMRs) of 99.93% and 99.87% for AUC and Cmax, respectively. Analysis of the safety data did not reveal any differences between RGB-10 and its reference. CONCLUSION Based on the high level of similarity in the preclinical data and the results of this clinical study, marketing authorisation for RGB-10 (Terrosa®) was granted by the European Medicines Agency (EMA) in 2017.
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Surgical Considerations in Managing Osteoporosis, Osteopenia, and Vitamin D Deficiency During Arthroscopic Rotator Cuff Repair.
Entezari, V, Lazarus, M
The Orthopedic clinics of North America. 2019;(2):233-243
Abstract
Osteopenia and osteoporosis are common in older adults and are associated with increased risk of fragility fractures. Vitamin D deficiency caused by chronic disease, poor nutrition, and inadequate sun exposure affects bone quality. Chronic rotator cuff tears can deteriorate the bone mineral density of the greater tuberosity and have been linked to reduced anchor pullout strength and high re-tear rate after repair especially in older patients with larger tear size. This article summarizes the current evidence on rotator cuff tear and bone quality and provides treatment strategies for rotator cuff repair in patients with poor bone quality.
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The next step after anti-osteoporotic drug discontinuation: an up-to-date review of sequential treatment.
Guañabens, N, Moro-Álvarez, MJ, Casado, E, Blanch-Rubió, J, Gómez-Alonso, C, Díaz-Guerra, GM, Del Pino-Montes, J, Valero Díaz de Lamadrid, C, Peris, P, Muñoz-Torres, M, et al
Endocrine. 2019;(3):441-455
Abstract
Several antiresorptive drugs, like bisphosphonates and denosumab, are currently available for the treatment of osteoporosis due to their evidenced efficacy in reducing fracture risk at mid-term. Osteoanabolic therapies, like teriparatide, whose treatment duration is limited to 2 years, have also shown efficacy in the reduction of fracture risk. However, depending on the severity of osteoporosis and the presence of other associated risk factors for fracture, some patients may require long-term treatment to preserve optimal bone strength and minimize bone fracture risk. Given the limited duration of some treatments, the fact that most of the antiresorptive drugs have not been assessed beyond 10 years, and the known long-term safety issues of these drugs, including atypical femoral fractures or osteonecrosis of the jaw, the long-term management of these patients may require an approach based on drug discontinuation and/or switching. In this regard, interest in sequential osteoporosis therapy, wherein drugs are initiated and discontinued over time, has grown in recent years, although the establishment of an optimal and individualized order of therapies remains controversial. This review reports the currently available clinical evidence on the discontinuation effects of different anti-osteoporotic drugs, as well as the clinical outcomes of the different sequential treatment regimens. The objective of this article is to present up-to-date practical knowledge on this area in order to provide guidance to the clinicians involved in the management of patients with osteoporosis.
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Efficacy of Jintiange Capsules in the Treatment of Osteoporosis: A Network Meta-analysis.
Sun, J, Yang, XG, Hu, YC
Orthopaedic surgery. 2019;(2):176-186
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Abstract
OBJECTIVE To evaluate the efficacy of Jintiange capsules and Jintiange combined with other therapies in the treatment of osteoporosis. METHODS A systematic review of the literature was conducted through databases including China National Knowledge Infrastructure (CNKI), the VIP Database for Chinese Technical Periodicals (VIP), Wanfang, and PubMed from inception to April 2018. Network meta-analysis was used to determine the relative efficacy of related treatments on osteoporosis. The primary outcome measures are the bone mineral density (BMD) of the lumbar and femoral neck, and the secondary outcome measures are visual analog pain score (VAS) and adverse events. Two reviewers independently selected the studies, extracted information, and assessed the quality of included trials. Data extracted from eligible studies was pooled and meta-analyzed, and the mean differences (MD) with their 95% confidence intervals were estimated as the effect size between treatments. RESULTS Thirty-one studies were included in this study, containing 28 randomized controlled trials (RCT) and 3 non-randomized controlled trials (non-RCT), with a total of 14 regimens treating osteoporosis. According to the surface under the cumulative ranking (SUCRA) curves, Jintiange capsules combined with atorvastatin (89.9%) and Jintiange combined with bisphosphonates (88.2%) have the best efficacy in terms of the BMD of the lumbar and femoral neck, respectively. Based on the VAS, Jintiange combined with calcium has the best analgesic effect (83.4%). CONCLUSION Jintiange capsules alone and combined with other therapies is a good choice for treating patients with osteoporosis in terms of improving BMD, relieving pain, and reducing adverse events. More large-scale and well-designed RCT are warranted to confirm the results of this study.
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Long-Term Ultra-High Hydrostatic Pressurized Brown Rice Intake Prevents Bone Mineral Density Decline in Elderly Japanese Individuals.
Matsuzaki, K, Yano, S, Sumiyoshi, E, Shido, O, Katsube, T, Tabata, M, Okuda, M, Sugimoto, H, Yoshino, K, Hashimoto, M
Journal of nutritional science and vitaminology. 2019;(Supplement):S88-S92
Abstract
Bone embrittlement with aging, namely osteoporosis, is characterized by low bone mass and deterioration of bone tissue, and can lead to increased risk of fracture. The development of functional foods that can prevent geriatric diseases is in progress. Our focus was on brown rice because of its properties. An interventional study using of ultra-high hydrostatic pressurized brown rice (UHHPBR) for human has not yet been conducted. In this study, we investigated whether long-term dietary intake of UHHPBR prevents aging-related decline of bone mineral density in elderly Japanese individuals. Elderly participants (n=40; mean 73.1 y) in Iinan-cho, Shimane, Japan, were randomly divided into two groups. The UHHPBR-intake group (n=20) consumed 100 g of UHHPBR and 100 g of white rice (WR) per day for 12 mo, while the WR-intake group (n=20) consumed 200 g of WR per day. Pre- and 12-mo post-intervention, bone mineral density was evaluated by quantitative ultrasound. After 12 mo of intervention, the UHHPBR group's bone mineral density was significantly higher than the WR group's bone mineral density. Moreover, chronic intake of UHHPBR had no adverse side effects on participants. Long-term oral UHHPBR intake may have beneficial effects on bone mineral density decline and may attenuate osteoporosis in the elderly.
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Exercise for the prevention of osteoporosis in postmenopausal women: an evidence-based guide to the optimal prescription.
Daly, RM, Dalla Via, J, Duckham, RL, Fraser, SF, Helge, EW
Brazilian journal of physical therapy. 2019;(2):170-180
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Abstract
BACKGROUND Osteoporosis and related fragility fractures are a global public health problem in which pharmaceutical agents targeting bone mineral density (BMD) are the first line of treatment. However, pharmaceuticals have no effect on improving other key fracture risk factors, including low muscle strength, power and functional capacity, all of which are associated with an increased risk for falls and fracture, independent of BMD. Targeted exercise training is the only strategy that can simultaneously improve multiple skeletal and fall-related risk factors, but it must be appropriately prescribed and tailored to the desired outcome(s) and the specified target group. OBJECTIVES In this review, we provide an overview of the general principles of training and specific loading characteristics underlying current exercise guidelines for the prevention of osteoporosis, and an update on the latest scientific evidence with regard to the type and dose of exercise shown to positively influence bone mass, structure and strength and reduce fracture risk in postmenopausal women.
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Dietary Patterns in Relation to Low Bone Mineral Density and Fracture Risk: A Systematic Review and Meta-Analysis.
Fabiani, R, Naldini, G, Chiavarini, M
Advances in nutrition (Bethesda, Md.). 2019;(2):219-236
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Low bone mineral density (BMD) and osteoporosis-related fractures constitute a considerable public health burden. Several studies have demonstrated the association between diet and bone health. We performed a systematic review to provide an estimate of the association between different dietary patterns defined through the use of a posteriori methods and fracture or low BMD risk. A literature search on PubMed, Web of Science, and Scopus databases, up to March 2018, was performed to identify all eligible case-control, prospective, or cross-sectional studies involving subjects of both sexes and any age. Random-effects models were used. Heterogeneity and publication bias were evaluated. Stratified analyses were conducted on study characteristics. The meta-analysis includes 20 studies and identifies 3 prevalent dietary patterns: "Healthy," "Milk/dairy," and "Meat/Western." From the 10 studies on fracture, adherence to the "Healthy" pattern reduced the risk, particularly in older people (OR: 0.79; 95% CI: 0.66, 0.95; P = 0.011) and in Eastern countries (OR: 0.64; 95% CI: 0.43, 0.97; P = 0.037), whereas the risk increased with the "Meat/Western" pattern, especially for older people (OR: 1.11; 95% CI: 1.04, 1.18, P = 0.001), in those with hip fractures (OR: 1.15; 95% CI: 1.05, 1.25; P = 0.002), and in Western countries (OR: 1.10; 95% CI: 1.07, 1.14; P < 0.0001). Analyses on low BMD showed a reduced risk in the "Healthy" pattern, particularly for younger people (OR: 0.62; 95% CI: 0.44, 0.89; P = 0.009). The "Meat/Western" pattern increased low BMD risk, especially in older people (OR: 1.31; 95% CI: 1.05, 1.64; P = 0.015). The "Milk/dairy" pattern resulted in the strongest reduction in low BMD risk; when stratifying, this effect remained significant (e.g., older women-OR: 0.57; 95% CI: 0.46, 0.70; P < 0.0001). Nutrition is an important modifiable factor affecting bone health. The "Healthy" and "Milk/dairy" patterns are associated with a reduced risk of low BMD and fracture. In contrast, the "Western" pattern is inversely associated.
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Radiofrequency echographic multi-spectrometry for the in-vivo assessment of bone strength: state of the art-outcomes of an expert consensus meeting organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).
Diez-Perez, A, Brandi, ML, Al-Daghri, N, Branco, JC, Bruyère, O, Cavalli, L, Cooper, C, Cortet, B, Dawson-Hughes, B, Dimai, HP, et al
Aging clinical and experimental research. 2019;(10):1375-1389
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Abstract
PURPOSE The purpose of this paper was to review the available approaches for bone strength assessment, osteoporosis diagnosis and fracture risk prediction, and to provide insights into radiofrequency echographic multi spectrometry (REMS), a non-ionizing axial skeleton technique. METHODS A working group convened by the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis met to review the current image-based methods for bone strength assessment and fracture risk estimation, and to discuss the clinical perspectives of REMS. RESULTS Areal bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA) is the consolidated indicator for osteoporosis diagnosis and fracture risk assessment. A more reliable fracture risk estimation would actually require an improved assessment of bone strength, integrating also bone quality information. Several different approaches have been proposed, including additional DXA-based parameters, quantitative computed tomography, and quantitative ultrasound. Although each of them showed a somewhat improved clinical performance, none satisfied all the requirements for a widespread routine employment, which was typically hindered by unclear clinical usefulness, radiation doses, limited accessibility, or inapplicability to spine and hip, therefore leaving several clinical needs still unmet. REMS is a clinically available technology for osteoporosis diagnosis and fracture risk assessment through the estimation of BMD on the axial skeleton reference sites. Its automatic processing of unfiltered ultrasound signals provides accurate BMD values in view of fracture risk assessment. CONCLUSIONS New approaches for improved bone strength and fracture risk estimations are needed for a better management of osteoporotic patients. In this context, REMS represents a valuable approach for osteoporosis diagnosis and fracture risk prediction.
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Microbial osteoporosis: The interplay between the gut microbiota and bones via host metabolism and immunity.
Li, L, Rao, S, Cheng, Y, Zhuo, X, Deng, C, Xu, N, Zhang, H, Yang, L
MicrobiologyOpen. 2019;(8):e00810
Abstract
The complex relationship between intestinal microbiota and host is a novel field in recent years. A large number of studies are being conducted on the relationship between intestinal microbiota and bone metabolism. Bone metabolism consisted of bone absorption and formation exists in the whole process of human growth and development. The nutrient components, inflammatory factors, and hormone environment play important roles in bone metabolism. Recently, intestinal microbiota has been found to influence bone metabolism via influencing the host metabolism, immune function, and hormone secretion. Here, we searched relevant literature on Pubmed and reviewed the effect of intestinal microbiota on bone metabolism through the three aspects, which may provide new ideas and targets for the clinical treatment of osteoporosis.
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Polyphenol-Rich Foods and Osteoporosis.
Chisari, E, Shivappa, N, Vyas, S
Current pharmaceutical design. 2019;(22):2459-2466
Abstract
BACKGROUND Osteoporosis is a metabolic disease affecting the bone mineral density and thus compromise the strength of the bones. Disease prevention through diet is the objective of the study and discussion. Among the several nutrients investigated, the intake of phenols seems to influence bone mineral density by acting as free radical scavengers, preventing oxidation-induced damage to bone cells. In addition, the growing understanding of the bone remodelling process supports the theory that inflammation significantly contributes to the etiopathogenesis of osteoporosis. METHODS To provide an overview of current evidence on polyphenol-rich foods and osteoporosis prevention we made a comprehensive review of the literature focusing on the state of art of the topic. RESULTS Some polyphenol-rich foods, including olive oil, fruit and vegetable, tea and soy, seem to be beneficial for preventing osteoporosis disease and its progression. The mechanism is still partly unknown and may involve different pathways which include inflammation and other disease reactions. CONCLUSIONS However, further research is needed to better understand the mechanisms regulating the molecular interaction between osteoporosis incidence and progression and polyphenol-rich foods. The current evidence suggests that dietary intervention with polyphenol rich foods may be useful to prevent incidence and progression of this condition.