References of "Reginster, Jean-Yves"
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See detailAntifracture efficacy and safety of once-yearly Zoledronic acid 5mg in men with osteoporosis: a prospective, randomized, controlled trial
Boonen, Steven; Su, Guoqin; Incera, Elodie et al

in Osteoporosis International (2011, March), 22(Suppl.1), 112

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See detailFive-year Denosumab treatment of postmenopausal women with osteoporosis: results from the first two years of the freedom trial extension
Papapoulos, S.; Man, Z.; Mellstrom, D. et al

in Osteoporosis International (2011, March), 22(Suppl.1), 107-108

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See detailStrontium ranelate increases cell viability in IL-1 beta stimulated human chondrocytes
Merville, Marie-Paule ULg; Deroyer, Céline ULg; Bruyère, Olivier ULg et al

in Osteoporosis International (2011, March), 22(Suppl.1), 53-54384

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See detailRisk of hip fracture in community-dwelling and institutionalized osteoporotic patients: a 3-year study
Bruyère, Olivier ULg; Hiligsmann, Mickaël ULg; Zegels, Brigitte ULg et al

in Osteoporosis International (2011, March), 22(Suppl.1), 332-333

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See detailIncidence of hip fracture in Belgium between 2000 and 2007 and future projections
Hiligsmann, Mickaël ULg; Bruyère, Olivier ULg; Detilleux, Johann ULg et al

in Osteoporosis International (2011, March), 22(Suppl.1), 145

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See detailRelationship between changes in bone mineral density or bone turnover markers and vertebral fracture incidence in patients treated with Bazedoxifene
Bruyère, Olivier ULg; Detilleux, Johann ULg; Chines, Arkadi et al

in Osteoporosis International (2011, March), 22(Suppl.1), 324

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See detailStable precision over time when assessing the cartilage loss on knee osteoarthritis radiograph
DEROISY, Rita ULg; Bruyère, Olivier ULg; Reginster, Jean-Yves ULg

in Osteoporosis International (2011, March), 22(Suppl.1), 42-43246

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See detailArzoxifene for prevention of fractures and invasive breast cancer in postmenopausal women.
Cummings, S. R.; McClung, M.; Reginster, Jean-Yves ULg et al

in Journal of Bone and Mineral Research (2011), 26(2), 397-404

BACKGROUND: Arzoxifene is a selective estrogen receptor modulator (SERM) more potent in preclinical testing than currently available agents. Its effects on clinical outcomes are not known. METHODS: In a ... [more ▼]

BACKGROUND: Arzoxifene is a selective estrogen receptor modulator (SERM) more potent in preclinical testing than currently available agents. Its effects on clinical outcomes are not known. METHODS: In a randomized blinded trial, women age 60 to 85 years with osteoporosis, defined as a femoral neck or lumbar spine bone mineral density T-score less than or equal to -2.5 or a vertebral fracture, and women with low bone mass, defined as a bone density T-score less than or equal to -1.0 and above -2.5, were assigned to arzoxifene 20 mg or placebo daily. The primary endpoints were new vertebral fracture in those with osteoporosis, and invasive breast cancer in the overall population. RESULTS: After 3 years, the cumulative incidence of vertebral fractures in patients with osteoporosis was 2.3% lower in the arzoxifene than in the placebo group, a 41% relative risk reduction (95% CI 0.45 to 0.77; P<0.001). In the overall population, the cumulative incidence of invasive breast cancer over 4 years was reduced by 1.3%, with a 56% relative reduction in risk (HR=0.44; 95% CI 0.26 to 0.76; P<0.001); there was no significant decrease in nonvertebral fracture risk. Arzoxifene increased the cumulative incidence of venous thromboembolic events by 0.7%, with a 2.3-fold relative increase (95% CI 1.5 to 3.7). CONCLUSION: Like other SERMs, arzoxifene decreased vertebral fractures and invasive breast cancer while the risk of venous thromboembolic events increased. (c) 2010 American Society for Bone and Mineral Research. [less ▲]

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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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