References of "DIEZ-PEREZ, A"
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See detailInternational Osteoporosis Foundation and European Calcified Tissue Society working group. Recommendations for the screening of the adherence to oral bisphosphonates.
DIEZ-PEREZ, A; NAYLOR, K.E.; ABRAHAMSEN, B et al

in Osteoporosis International (2017), 28(3), 767-774

Summary: Adherence to oral bisphosphonates is low. A screening strategy is proposed based on the response of biochemical markers of bone turnover after 3 months of therapy. If no change is observed, the ... [more ▼]

Summary: Adherence to oral bisphosphonates is low. A screening strategy is proposed based on the response of biochemical markers of bone turnover after 3 months of therapy. If no change is observed, the clinician should reassess the adherence to the treatment and also other potential issues with the drug. Introduction: Low adherence to oral bisphosphonates is a common problem that jeopardizes the efficacy of treatment of osteoporosis. No clear screening strategy for the assessment of compliance is widely accepted in these patients. Methods: The International Osteoporosis Foundation and the European Calcified Tissue Society have convened a working group to propose a screening strategy to detect a lack of adherence to these drugs. The question to answer was whether the bone turnover markers (BTMs) PINP and CTX can be used to identify low adherence in patients with postmenopausal osteoporosis initiating oral bisphosphonates for osteoporosis. The findings of the TRIO study specifically address this question and were used as the basis for testing the hypothesis. Results: Based on the findings of the TRIO study, specifically addressing this question, the working group recommends measuring PINP and CTX at baseline and 3 months after starting therapy to check for a decrease above the least significant change (decrease of more than 38% for PINP and 56% for CTX). Detection rate for the measurement of PINP is 84%, for CTX 87% and, if variation in at least one is considered when measuring both, the level of detection is 94.5%. Conclusions: If a significant decrease is observed, the treatment can continue, but if no decrease occurs, the clinician should reassess to identify problems with the treatment, mainly low adherence. [less ▲]

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See detailPatients' preferences for anti-osteoporosis drug treatment: A cross-European discrete choice experiment
Hiligsmann, M.; Dellaert, B. G.; Dirksen, C. D. et al

in Rheumatology (2017), 56(7), 1167-1176

Objectives. To estimate the preferences of osteoporotic patients for medication attributes, and analyse data from seven European countries. Methods. A discrete choice experiment was conducted in Belgium ... [more ▼]

Objectives. To estimate the preferences of osteoporotic patients for medication attributes, and analyse data from seven European countries. Methods. A discrete choice experiment was conducted in Belgium, France, Ireland, the Netherlands, Spain, Switzerland and the UK. Patients were asked to choose repeatedly between two hypothetical unlabelled drug treatments (and an opt-out option) that varied with respect to four attributes: efficacy in reducing the risk of fracture, type of potential common side effects, and mode and frequency of administration. In those countries in which patients contribute to the cost of their treatment directly, a fifth attribute was added: out-of-pocket cost. A mixed logit panel model was used to estimate patients' preferences. Results. In total, 1124 patients completed the experiment, with a sample of between 98 and 257 patients per country. In all countries, patients preferred treatment with higher effectiveness, and 6-monthly subcutaneous injection was always preferred over weekly oral tablets. In five countries, patients also preferred a monthly oral tablet and yearly i.v. injections over weekly oral tablets. In the three countries where the out-of-pocket cost was included as an attribute, lower costs significantly contributed to the treatment preference. Between countries, there were statistically significant differences for 13 out of 42 attribute/level interactions. Conclusion. We found statistically significant differences in patients' preferences for anti-osteoporosis medications between countries, especially for the mode of administration. Our findings emphasized that international treatment recommendations should allow for local adaptation, and that understanding individual preferences is important if we want to improve the quality of clinical care for patients with osteoporosis. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. [less ▲]

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See detailBalancing benefits and risks of glucocorticoids in rheumatic diseases and other inflammatory joint disorders: new insights from emerging data. An expert consensus paper from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO)
Cooper, C.; Bardin, T.; Brandi, M.L. et al

in Aging Clinical and Experimental Research (2016), 28(1), 1-16

Purpose: This consensus review article considers the question of whether glucocorticoid (GC) therapy is still relevant in the treatment of rheumatic diseases, with a particular focus on rheumatoid ... [more ▼]

Purpose: This consensus review article considers the question of whether glucocorticoid (GC) therapy is still relevant in the treatment of rheumatic diseases, with a particular focus on rheumatoid arthritis (RA), and whether its side effects can be adequately managed. Recent basic and clinical research on the molecular, cellular and clinical effects of GCs have considerably advanced our knowledge in this field. An overview of the subject seems appropriate. Methods: This review is the result of a multidisciplinary expert working group, organised by European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis. The recent literature was surveyed and the salient evidence synthetized. Results: The pathophysiological basis of RA (and other inflammatory rheumatic diseases) now strongly implicates the adaptive immune system in addition to innate mechanisms. The molecular effect of GCs and differential GC sensitivity is better understood, although exploiting this knowledge is still in its infancy. The newer treatment strategies of early and aggressive control of RA have greatly improved clinical outcomes, but improvements are still possible. Newer targeted anti-inflammatory drugs have made an important impact, yet they too are associated with numerous side effects. Discussion: Short durations of moderate doses of GCs are generally well tolerated and have a positive benefit/risk ratio. Patients should be assessed for fracture risk and bone preserving agents and be prescribed calcium and vitamin D supplementation. Conclusions: Within a strategy of a disease modifying approach to inflammatory disease, combination therapy including a GC is effective approach. [less ▲]

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See detailErratum to: Management of osteoporosis of the oldest old
Rizzoli, R; Branco, J; Brandi, ML et al

in Osteoporosis International (2014), 25

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See detailManagement of osteoporosis of the oldest old.
Rizzoli, R.; Branco, J.; Brandi, M.-L. et al

in Osteoporosis International (2014), 25

This consensus article reviews the diagnosis and treatment of osteoporosis in geriatric populations. Specifically, it reviews the risk assessment and intervention thresholds, the impact of nutritional ... [more ▼]

This consensus article reviews the diagnosis and treatment of osteoporosis in geriatric populations. Specifically, it reviews the risk assessment and intervention thresholds, the impact of nutritional deficiencies, fall prevention strategies, pharmacological treatments and their safety considerations, the risks of sub-optimal treatment adherence and strategies for its improvement. INTRODUCTION: This consensus article reviews the therapeutic strategies and management options for the treatment of osteoporosis of the oldest old. This vulnerable segment (persons over 80 years of age) stands to gain substantially from effective anti-osteoporosis treatment, but the under-prescription of these treatments is frequent. METHODS: This report is the result of an ESCEO (European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis) expert working group, which explores some of the reasons for this and presents the arguments to counter these beliefs. The risk assessment of older individuals is briefly reviewed along with the differences between some intervention guidelines. The current evidence on the impact of nutritional deficiencies (i.e. calcium, protein and vitamin D) is presented, as are strategies to prevent falls. One possible reason for the under-prescription of pharmacological treatments for osteoporosis in the oldest old is the perception that anti-fracture efficacy requires long-term treatment. However, a review of the data shows convincing anti-fracture efficacy already by 12 months. RESULTS: The safety profiles of these pharmacological agents are generally satisfactory in this patient segment provided a few precautions are followed. CONCLUSION: These patients should be considered for particular consultation/follow-up procedures in the effort to convince on the benefits of treatment and to allay fears of adverse drug reactions, since poor adherence is a major problem for the success of a strategy for osteoporosis and limits cost-effectiveness. [less ▲]

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See detailThe role of dietary protein and vitamin D in maintaining musculoskeletal health in postmenopausal women : A consensus statement from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO)
Rizzoli, R; Stevenson, JC; Bauer, JM et al

in Maturitas (2014), 79

From 50 years of age, postmenopausal women are at an increased risk of developing sarcopenia and osteoporosis as a result of deterioration of musculoskeletal health. Both disorders increase the risk of ... [more ▼]

From 50 years of age, postmenopausal women are at an increased risk of developing sarcopenia and osteoporosis as a result of deterioration of musculoskeletal health. Both disorders increase the risk of falls and fractures. The risk of developing sarcopenia and osteoporosis may be attenuated through healthy lifestyle changes, which include adequate dietary protein, calcium and vitamin D intakes, and regular physical activity/exercise, besides hormone replacement therapy when appropriate. Protein intake and physical activity are the main anabolic stimuli for muscle protein synthesis. Exercise training leads to increased muscle mass and strength, and the combination of optimal protein intake and exercise produces a greater degree of muscle protein accretion than either intervention alone. Similarly, adequate dietary protein intake and resistance exercise are important contributors to the maintenance of bone strength. Vitamin D helps to maintain muscle mass and strength as well as bone health. These findings suggest that healthy lifestyle measures in women aged >50 years are essential to allow healthy ageing. The European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) recommends optimal dietary protein intake of 1.0–1.2 g/kg body weight/d with at least 20–25 g of high-quality protein at each main meal, with adequate vitamin D intake at 800 IU/d to maintain serum 25-hydroxyvitamin D levels >50 nmol/L as well as calcium intake of 1000 mg/d, alongside regular physical activity/exercise 3–5 times/week combined with protein intake in close proximity to exercise, in postmenopausal women for prevention of age-related deterioration of musculoskeletal health. [less ▲]

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See detailPreferences of patients for osteoporosis drug treatment: a cross-european discrete choice experiment
Hiligsmann, Mickaël ULiege; Dellaert, BG; Dirksen, CD et al

in Osteoporosis International (2014), 25(2), 227-228

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See detailInhibition de la sclérostine par le romosozumab chez des femmes ménopausées ayant une DMO basse : résultats de l'étude de phase 2
Brown, JP; McClung, MR; Grauer, A et al

in Revue du Rhumatisme (2013), 80(S1), 73

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See detailInhibition of sclerostin with romosozumab in postmenopausal women with low BMD : phase 2 trial results
McClung, M; Grauer, A; Boonen, S et al

in Osteoporosis International (2013), 24(1), 38-39

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See detailTreatment of osteoporosis in men.
Kaufman, JM; Reginster, Jean-Yves ULiege; Boonen, S et al

in BONE (2013), 53(1), 134-44

SUMMARY: Aspects of osteoporosis in men, such as screening and identification strategies, definitions of diagnosis and intervention thresholds, and treatment options (both approved and in the pipeline ... [more ▼]

SUMMARY: Aspects of osteoporosis in men, such as screening and identification strategies, definitions of diagnosis and intervention thresholds, and treatment options (both approved and in the pipeline) are discussed. INTRODUCTION: Awareness of osteoporosis in men is improving, although it remains under-diagnosed and under-treated. A European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) workshop was convened to discuss osteoporosis in men and to provide a report by a panel of experts (the authors). METHODS: A debate with an expert panel on preselected topics was conducted. RESULTS AND CONCLUSIONS: Although additional fracture data are needed to endorse the clinical care of osteoporosis in men, consensus views were reached on diagnostic criteria and intervention thresholds. Empirical data in men display similarities with data acquired in women, despite pathophysiological differences, which may not be clinically relevant. Men should receive treatment at a similar 10-year fracture probability as in women. The design of mixed studies may reduce the lag between comparable treatments for osteoporosis in women becoming available in men. [less ▲]

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See detailManagement of glucocorticoid-induced osteoporosis
Rizzoli, R.; Adachi, J. D.; Cooper, C. et al

in Calcified Tissue International (2012), 91(4), 225-243

This review summarizes the available evidence-based data that form the basis for therapeutic intervention and covers the current status of glucocorticoid-induced osteoporosis (GIOP) management, regulatory ... [more ▼]

This review summarizes the available evidence-based data that form the basis for therapeutic intervention and covers the current status of glucocorticoid-induced osteoporosis (GIOP) management, regulatory requirements, and risk-assessment options. Glucocorticoids are known to cause bone loss and fractures, yet many patients receiving or initiating glucocorticoid therapy are not appropriately evaluated and treated. An European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis workshop was convened to discuss GIOP management and to provide a report by a panel of experts. An expert panel reviewed the available studies that discussed approved therapeutic agents, focusing on randomized and controlled clinical trials reporting on bone mineral density and/or fracture risk of at least 48 weeks' duration. There is no evidence that GIOP and postmenopausal osteoporosis respond differently to treatments. The FRAX algorithm can be adjusted according to glucocorticoid dose. Available antiosteoporotic therapies such as bisphosphonates and teriparatide are efficacious in GIOP management. Several other agents approved for the treatment of postmenopausal osteoporosis may become available for GIOP. It is advised to stop antiosteoporotic treatment after glucocorticoid cessation, unless the patient remains at increased risk of fracture. Calcium and vitamin D supplementation as an osteoporosis-prevention measure is less effective than specific antiosteoporotic treatment. Fracture end-point studies and additional studies investigating specific subpopulations (pediatric, premenopausal, or elderly patients) would strengthen the evidence base and facilitate the development of intervention thresholds and treatment guidelines. © Springer Science+Business Media, LLC 2012. [less ▲]

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See detailStrontium ranelate decreases the risk of hip fracture over 3 and 5 years in post menopausal women at high risk
Reginster, Jean-Yves ULiege; Felsenberg, D.; Boonen, Steven et al

in Annals of the Rheumatic Diseases (2008, June), 67(Suppl.II), 540

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See detailStrontium ranelate demonstrates efficacy against hip fracture over 3 and 5 years in postmenopausal women at high risk of hip fracture
Reginster, Jean-Yves ULiege; Felsenberg, D.; Boonen, Steven et al

in Osteoporosis International (2008, April), 19(Suppl.1), 26-27

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See detailRecommendations for an update of the current (2001) regulatory requirements for registration of drugs to be used in the treatment of osteoporosis in postmenopausal women and in men
Reginster, Jean-Yves ULiege; Abadie, Eric ULiege; Delmas, P. et al

in Osteoporosis International (2006), 17(1), 1-7

Recent advances in the understanding of the epidemiology of osteoporosis suggest that certain parts of the current European guidelines for the registration of drugs in osteoporosis might be no longer ... [more ▼]

Recent advances in the understanding of the epidemiology of osteoporosis suggest that certain parts of the current European guidelines for the registration of drugs in osteoporosis might be no longer substantiated. The object of this review is to provide the European regulatory authorities with an evidence-based working document providing suggestions for the revision of the "Note for guidance for the approval of drugs to be used in postmenopausal osteoporosis" (CPMP/EWP/552/95). Following an extensive review of the literature (1990-2004), the Group for the Respect of Ethics and Excellence in Science (GREES) organized a workshop including European regulators, academic scientists and representatives of the pharmaceutical industry. The outcomes of this meeting reflect the personal views of those who attended and should not, in any case, be seen as an official position paper of any regulatory agency. The group identified a certain number of points that deserve discussion. They mainly relate to the nature of the indication being granted to new chemical entities (treatment of osteoporosis in women at high risk of fracture instead of prevention and treatment of osteoporosis), the requirements of showing an anti-fracture efficacy on all or on major nonvertebral fractures (instead of the hip), the duration of pivotal trials (2 years instead of 3) and the possibility of considering bridging studies for new routes of administration, new doses or new regimens of previously approved drugs. The group also recommends that an indication could be granted for the treatment of osteoporosis in males on the basis of a placebo-controlled study, with bone mineral density changes after 1 year as the primary endpoint, for medications approved in the treatment of osteoporosis in women at high risk of fractures. [less ▲]

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See detailRelationship between changes in biochemical markers of bone turnover and BMD to predict vertebral fracture risk
Sarkar, S.; Reginster, Jean-Yves ULiege; Crans, G. G. et al

in Journal of Bone and Mineral Research (2004), 19(3), 394-401

The change in BMD is a poor predictor of vertebral fracture risk after raloxifene treatment. One-year percent change in bone turnover and BMD was used to predict vertebral fracture risk. The percent ... [more ▼]

The change in BMD is a poor predictor of vertebral fracture risk after raloxifene treatment. One-year percent change in bone turnover and BMD was used to predict vertebral fracture risk. The percent change in osteocalcin was determined to be a better predictor of vertebral fracture risk than BMD. Introduction: The association between baseline BMD and fracture risk is well understood. However, the relationship between changes in BMD and fracture risk is not well defined. It has previously been demonstrated that BMD change was a poor predictor of vertebral fracture risk in raloxifene-treated women, whereas bone turnover markers were significantly associated with fracture risk. In the current analysis, we explore the prediction of vertebral fracture risk using changes in both BMD and bone turnover. Materials and Methods: The Multiple Outcomes of Raloxifene Evaluation (MORE) trial was a randomized, placebo-controlled trial of 7705 women with osteoporosis treated with raloxifene 60 or 120 mg/day for 3 years. Markers of bone turnover were measured in one-third of the study population (n = 2503), and the present analyses include these women. Logistic regression models were constructed using one-year percent changes in BMD and bone turnover and relevant baseline demographics to predict the risk of vertebral fracture with pooled raloxifene therapy at 3 years. All covariates were standardized before modeling to facilitate direct comparisons between changes in BMD and bone turnover. Results and Conclusion: Prevalent vertebral fracture status (p < 0.0001), baseline lumbar spine BMD (p < 0.0001), and number of years postmenopausal (p = 0.0005) were independent predictors of fracture risk in raloxifene-treated patients. Therapy-by-change in femoral neck BMD (p = 0.02) and therapy-by-change in osteocalcin (OC; p = 0.01) were also significant for all treatment groups, indicating that changes in BMD and OC have different effects on fracture risk for the placebo and pooled raloxifene groups. The final model included significant baseline variables and change in OC (p = 0.01), whereas change in femoral neck BMD was not significant. After adjustment of each significant baseline variable, the percent change in OC was better able to predict the reduction in vertebral fracture risk than the percent change in femoral neck BMD in patients treated with raloxifene. [less ▲]

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See detailOptimizing patient adherence and persistence in strontium ranelate phase 3 program using a short term run-in study
Reginster, Jean-Yves ULiege; Spector, Tim; Badurski, J. et al

in Osteoporosis International (2002, November), 13(Suppl.3), 35-36

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See detailSupplementation of calcium-vitamin D should be adapted according to the patients status in international phase 3 program on osteoporosis
Reginster, Jean-Yves ULiege; Diez-Perez, A.; Ortolani, S. et al

in Osteoporosis International (2002, November), 13(Suppl.3), 35

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See detailA short-term run-in study can significantly contribute to increasing the quality of long-term osteoporosis trials. The strontium-ranelate phase 3 program
Reginster, Jean-Yves ULiege; Spector, T.; Badurski, J. et al

in Osteoporosis International (2002), 13(S1), 30

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See detailCalcium-vitamin D supplementation in clinical trials of osteoporosis should be titrated on the basis of pre-study assessments
Reginster, Jean-Yves ULiege; Diez-Perez, A.; Ortolani, S. et al

in Osteoporosis International (2002), 13(S1), 24

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