References of "Reginster, Jean-Yves"
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See detailCutaneous side effects of antiosteoporosis treatments
Musette, P.; Kaufman, J.-M.; Rizzoli, R. et al

in Therapeutic Advances in Musculoskeletal Disease (2011), 3(1), 31-41

Cutaneous adverse reactions are reported for many therapeutic agents and, in general, are observed in between 0% and 8% of treated patients depending on the drug. Antiosteoporotic agents are considered to ... [more ▼]

Cutaneous adverse reactions are reported for many therapeutic agents and, in general, are observed in between 0% and 8% of treated patients depending on the drug. Antiosteoporotic agents are considered to be safe in terms of cutaneous effects, however there have been a number of case reports of cutaneous adverse reactions which warrant consideration. This was the subject of a working group meeting of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis in April 2009, which focused on the impact of cutaneous adverse reactions and drug-induced hypersensitivity in the management of postmenopausal osteoporosis. This position paper was drafted following these discussions and includes a flowchart for their recognition. Cutaneous adverse reactions observed with antiosteoporotic agents were reviewed and included information from case reports, regulatory documents and pharmacovigilance. These reactions ranged from benign effects including exanthematous or maculopapular eruption (drug rash), photosensitivity and urticaria, to the severe and potentially life-threatening reactions of angioedema, drug rash with eosinophilia and systemic symptoms (DRESS), Stevens Johnson syndrome and toxic epidermal necrolysis. A review of the available evidence demonstrates that cutaneous adverse reactions occur with all commonly used antiosteoporotic treatments. Notably, there are reports of Stevens Johnson syndrome and toxic epidermal necrolysis for bisphosphonates, and of DRESS and toxic epidermal necrolysis for strontium ranelate. These severe reactions remain very rare (<1 in 10,000 cases). In general, with proper management and early recognition, including immediate and permanent withdrawal of the culprit agent, accompanied by hospitalization, rehydration and systemic corticosteroids if necessary, the prognosis is positive. © The Author(s), 2011. [less ▲]

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See detailRecommendations for an update of 2003 European regulatory requirements for registration of drugs to be used in the treatment of RA.
Smolen, Josef S.; Boers, Maarten; Abadie, Eric ULg et al

in Current Medical Research & Opinion (2011), 27(2), 315-25

Since 2003, the European Medicines Agency (EMA) document, 'Points to consider on clinical investigation of medicinal products other than NSAIDs (nonsteroidal anti-inflammatory drugs) for the treatment of ... [more ▼]

Since 2003, the European Medicines Agency (EMA) document, 'Points to consider on clinical investigation of medicinal products other than NSAIDs (nonsteroidal anti-inflammatory drugs) for the treatment of rheumatoid arthritis' has provided guidance for the clinical development of both biologic and non-biologic disease-modifying antirheumatic drugs (DMARDs). In the last few years, several new products have been developed or are in development for the treatment of RA, which offer significant efficacy with regard to disease control, including prevention of structural damage and disability. Concurrently, novel insights have been gained with respect to the assessment of disease activity, joint damage and disability. New treatment strategies have been established which relate to early therapy, tight control and rapid switching of medication. Accordingly, several new EULAR/ACR recommendations have been or are being developed. Several important additions and changes are needed in the 2003 guidance to incorporate the current scientific knowledge into clinical trial design for the development of future products. Under the auspices of the Group for the Respect of Ethics and Excellence in Science (GREES), a group of experts in the field of RA and clinical trial design met to provide a consensus recommendation for an update to the 2003 EMA guidance document. [less ▲]

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See detailUpdating the 2003 European regulatory requirements for registering disease-modifying drugs to be used in the treatment of rheumatoid arthritis.
Smolen, Josef S.; Boers, Maarten; Abadie, Eric ULg et al

in Rheumatology (2011), 50(10), 1732-6

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See detailBiomarkers and personalised medicine in rheumatoid arthritis: a proposal for interactions between academia, industry and regulatory bodies.
Miossec, P.; Verweij, C. L.; Klareskog, L. et al

in Annals of the Rheumatic Diseases (2011), 70(10), 1713-8

Rheumatoid arthritis (RA) is one of the most appropriate conditions for the application of personalised medicine as a high degree of heterogeneity has been recognised, which remains to be explained. Such ... [more ▼]

Rheumatoid arthritis (RA) is one of the most appropriate conditions for the application of personalised medicine as a high degree of heterogeneity has been recognised, which remains to be explained. Such heterogeneity is also reflected in the large number of treatment targets and options. A growing number of biologics as well as small molecules are already in use and there are promising new drugs in development. In order to make the best use of treatment options, both targeted and non-targeted biomarkers have to be identified and validated. To this aim, new rules are needed for the interaction between academia and industry under regulatory control. Setting up multi-centre biosample collections with clear definition of access, organising early, possibly non-committing discussions with regulatory authorities, and defining a clear route for the validation, qualification and registration of the biomarker-drug combination are some of the more critical areas where effective collaboration between the drug industry, academia and regulators is needed. [less ▲]

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See detailAdverse drug reactions to osteoporosis treatments
Rizzoli, R.; Reginster, Jean-Yves ULg

in Expert Review of Clinical Pharmacology (2011), 4(5), 593-604

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See detailAdverse reactions and drug-drug interactions in the management of women with postmenopausal osteoporosis.
Rizzoli, Rene; Reginster, Jean-Yves ULg; Boonen, Steven et al

in Calcified Tissue International (2011), 89(2), 91-104

The pharmacological management of disease should involve consideration of the balance between the beneficial effects of treatment on outcome and the probability of adverse effects. The aim of this review ... [more ▼]

The pharmacological management of disease should involve consideration of the balance between the beneficial effects of treatment on outcome and the probability of adverse effects. The aim of this review is to explore the risk of adverse drug reactions and drug-drug interactions with treatments for postmenopausal osteoporosis. We reviewed evidence for adverse reactions from regulatory documents, randomized controlled trials, pharmacovigilance surveys, and case series. Bisphosphonates are associated with gastrointestinal effects, musculoskeletal pain, and acute-phase reactions, as well as, very rarely, atrial fibrillation, atypical fracture, delayed fracture healing, osteonecrosis of the jaw, hypersensitivity reactions, and renal impairment. Cutaneous effects and osteonecrosis of the jaw are of concern for denosumab (both very rare), though there are no pharmacovigilance data for this agent yet. The selective estrogen receptor modulators are associated with hot flushes, leg cramps, and, very rarely, venous thromboembolism and stroke. Strontium ranelate has been linked to hypersensitivity reactions and venous thromboembolism (both very rare) and teriparatide with headache, nausea, dizziness, and limb pain. The solidity of the evidence base depends on the frequency of the reaction, and causality is not always easy to establish for the very rare adverse reactions. Drug-drug interactions are rare. Osteoporosis treatments are generally safe and well tolerated, though they are associated with a few very rare serious adverse reactions. While these are a cause for concern, the risk should be weighed against the benefits of treatment itself, i.e., the prevention of osteoporotic fracture. [less ▲]

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See detailGlucosamine sulfate for structure modification in osteoarthritis : fact of fantasy ?
Reginster, Jean-Yves ULg

in Ortopedia, Traumatologia, Rehabilitacja (2011), 13(S1), 44

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See detailLong-term treatment of postmenopausal osteoporotic women with strontium ranelate : results at 10 years
Reginster, Jean-Yves ULg; Kaufman, J. M.; Devogelaer, J. D. et al

in Annals of the Rheumatic Diseases (2011), 70(S3), 167

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See detailReduction in incidence of vertebral fractures with once yearly zoledronic acid in men with osteoporosis
Boonen, S.; Kaufman, J. M.; Reginster, Jean-Yves ULg et al

in Journal of Bone and Mineral Research (2011), 26(S1), 23

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See detailLes allégations de santé dans le domaine de la santé osseuse
Bruyère, Olivier ULg; Reginster, Jean-Yves ULg

in Ortho-Rhumato (2011), 9(6), 215

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See detailDenosumab therapy in postmenopausal women with osteoporosis : results from the first two years of the freedom trial extension
Bone, H. G.; Chapurlat, R.; Brandi, M. L. et al

in Endocrine Reviews (2011), 32

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See detailA phase 3 study of the efficacy and safety of Denosumab in men with low bone mineral density : design of the ADAMO
Orwoll, E.; Stubbe Teglbjaerg, Ch; Langdahl, B. et al

in Journal of Bone and Mineral Research (2011), 26(S1), 511

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See detailSafety observations from denosumab long-term extension and cross-over studies in postmenopausal women with osteoporosis
Bone, H. G.; Chapurlat, R.; Libanati, C. et al

in Journal of Bone and Mineral Research (2011), 26(S1), 22-23

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See detailMaintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis
Reginster, Jean-Yves ULg; Kaufman, J. M.; Devogelaer, J. P. et al

in Arthritis and Rheumatism (2011), 63(S10), 436

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See detailNon-pharmacological management of osteoporosis: a consensus of the Belgian Bone Club
Body, J. J.; Bergmann, P.; Boonen, S. et al

in Osteoporosis International (2011), 22(11), 2769-88

This consensus article reviews the various aspects of the non-pharmacological management of osteoporosis, including the effects of nutriments, physical exercise, lifestyle, fall prevention, and hip ... [more ▼]

This consensus article reviews the various aspects of the non-pharmacological management of osteoporosis, including the effects of nutriments, physical exercise, lifestyle, fall prevention, and hip protectors. Vertebroplasty is also briefly reviewed. Non-pharmacological management of osteoporosis is a broad concept. It must be viewed as an essential part of the prevention of fractures from childhood through adulthood and the old age. The topic also includes surgical procedures for the treatment of peripheral and vertebral fractures and the post-fracture rehabilitation. The present document is the result of a consensus, based on a systematic review and a critical appraisal of the literature. Diets deficient in calcium, proteins or vitamin D impair skeletal integrity. The effect of other nutriments is less clear, although an excessive consumption of sodium, caffeine, or fibres exerts negative effects on calcium balance. The deleterious effects of tobacco, excessive alcohol consumption and a low BMI are well accepted. Physical activity is of primary importance to reach optimal peak bone mass but, if numerous studies have shown the beneficial effects of various types of exercise on bone mass, fracture data as an endpoint are scanty. Fall prevention strategies are especially efficient in the community setting, but less evidence is available about their effectiveness in preventing fall-related injuries and fractures. The efficacy of hip protectors remains controversial. This is also true for vertebroplasty and kyphoplasty. Several randomized controlled studies had reported a short-term advantage of vertebroplasty over medical treatment for pain relief, but these findings have been questioned by recent sham-controlled randomized clinical studies. [less ▲]

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See detailOstéroporose, le mal sournois
Reginster, Jean-Yves ULg

in Athena (2011), 276

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See detailThe clinical and economic burden of poor adherence with osteoporosis medications in Ireland
Hiligsmann, Mickaël ULg; McGowan, Bernie; Bennett, Kathleen et al

in Value in Health (2011), 14

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See detailAntifracture efficacy of currently available therapies for postmenopausal osteoporosis.
Reginster, Jean-Yves ULg

in Drugs (2011), 71(1), 65-78

Osteoporosis is a systemic bone disease characterized by low bone mass and bone mineral density, and deterioration of the underlying structure of bone tissue. These changes lead to an increase in bone ... [more ▼]

Osteoporosis is a systemic bone disease characterized by low bone mass and bone mineral density, and deterioration of the underlying structure of bone tissue. These changes lead to an increase in bone fragility and an increased risk for fracture, which are the clinical consequences of osteoporosis. The classical triad for consideration in osteoporosis is morbidity, mortality and cost. Vertebral fracture is an important source of morbidity in terms of pain and spinal deformity. On the other hand, hip fracture is associated with the worst outcomes and is widely regarded as a life-threatening event in the elderly; it is the source of the bulk of the cost of the disease in contemporary healthcare. The prevention of osteoporosis-associated fracture should include fall prevention, calcium supplementation and lifestyle advice, as well as pharmacological therapy using agents with proven antifracture efficacy. The most commonly used osteoporosis treatments in Europe are the bisphosphonates alendronate, risedronate, ibandronate and zoledronic acid; the selective estrogen receptor modulator (SERM) raloxifene; teriparatide; and strontium ranelate. Recent additions include the biological therapy denosumab and the SERM bazedoxifene. In this review, we explore the antifracture efficacy of these agents with the aim of simplifying treatment decisions. These treatments can be broadly divided according to their mode of action. The antiresorptive agents include the bisphosphonates, the SERMs and denosumab, while the bone-forming agents include parathyroid hormone and teriparatide. Strontium ranelate appears to combine both antiresorptive and anabolic activities. We collated data on vertebral and hip fracture efficacy from the pivotal 3-year phase III trials, all of which had a randomized, double-blind, placebo-controlled design. The relative reductions in risk in the osteoporosis trials range from 30% to 70% for vertebral fracture and 30% to 51% for hip fracture. This translates into 3-year number needed to treat values of between 9 and 21 for vertebral fracture and from 48 upwards for hip fracture. International guidelines agree that agents that have been shown to decrease vertebral, nonvertebral and hip fractures should be used preferentially over agents that only demonstrate vertebral antifracture efficacy. This is the case for alendronate, risedronate, zoledronic acid, denosumab and strontium ranelate. Finally, therapeutic decisions should be based on a balance between benefits and risks of treatment, which must be carefully considered in each particular case both by the physician and the patient. Indeed, no single agent is appropriate for all patients and, therefore, treatment decisions should be made on an individual basis, taking into account all measures of treatment effect and risk before making informed judgments about the best individual treatment option. [less ▲]

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See detailTraitement durant cinq ans par denosumab (DMAb) chez des femmes ménopausées ostéoporotiques : résultats d'efficacité des deux premières années de l'extension de l'essai FREEDOM
Chapurlat, R.; Roux, C.; Papapoulos, S. et al

in Revue du Rhumatisme (2011), 78(S5), 214

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