References of "Ethgen, D"
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See detailOsteoarthritis, magnetic resonance imaging, and biochemical markers: a one year prospective study
Bruyère, Olivier ULg; Collette, Julien ULg; Kothari, M. et al

in Annals of the Rheumatic Diseases (2006), 65(8), 1050-1054

Objective: To investigate the relation between biochemical markers of bone, cartilage, and synovial remodelling and the structural progression of knee osteoarthritis. Methods: 62 patients of both sexes ... [more ▼]

Objective: To investigate the relation between biochemical markers of bone, cartilage, and synovial remodelling and the structural progression of knee osteoarthritis. Methods: 62 patients of both sexes with knee osteoarthritis were followed prospectively for one year. From magnetic resonance imaging ( MRI), done at baseline and after one year, the volume and thickness of cartilage of the femur, the medial tibia, and the lateral tibia were assessed. A whole organ magnetic resonance imaging score ( WORMS) of the knee was calculated for each patient at baseline and at the one year visits. This score consists in a validated, semiquantitative scoring system for whole organ assessment of the knee in osteoarthritis using MRI. Biochemical markers ( serum hyaluronic acid, osteocalcin, cartilage glycoprotein 39 ( YKL-40), cartilage oligomeric matrix protein ( COMP), and C-telopeptide of type I collagen ( CTX-I), and urine C-telopeptide of type II collagen ( CTX-II)) were measured at baseline and after three months. Results: Baseline markers were not correlated with one year changes observed in cartilage volume and thickness. However, an increase in CTX-II after three months was significantly correlated with a one year decrease in mean thickness of medial tibial and lateral tibial cartilage. Patients in the highest quartile of three month changes in CTX-II experienced a mean loss of 0.07 ( 0.08) mm of their medial thickness, compared with a mean increase of 0.05 ( 0.19) mm for patients in the lowest quartile ( p = 0.04) Multiple regression analysis showed that high baseline levels of hyaluronic acid are predictive of a worsening in WORMS ( p = 0.004). Conclusions: These results suggest that a single measurement of serum hyaluronic acid or short term changes in urine CTX-II could identify patients at greatest risk of progression of osteoarthritis. [less ▲]

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See detailLongitudinal study of magnetic resonance imaging and fixed-flexion radiography to assess progression of osteoarthritis of the knee
Bruyère, Olivier ULg; Kothari, M.; Peterfy, C. et al

in Osteoporosis International (2006, March), 17(Suppl.1), 85

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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 ULg; Abadie, Eric ULg; 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 detailRecommendations for the registration of agents used in the prevention and treatment of glucocorticoid-induced osteoporosis: updated recommendations from GREES
Abadie, Eric ULg; Devogealer, Jean-Pierre; Ringe, J. et al

in Osteoporosis International (2005, March), 16(Suppl.3), 47

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See detailOne-year progression of knee osteoarthritis: correlations between X-Rays and magnetic resonance imaging changes
Bruyère, Olivier ULg; Kothari, M.; Zaim, S. et al

in Osteoporosis International (2005, March), 16(Suppl.3), 46-47

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See detailFemoro-tibial joint space width, assessed by standard X-Ray, is associated with tibial cartilage volume and thickness, assessed by magnetic resonance imaging
Bruyère, Olivier ULg; Kothari, M.; Zaim, S. et al

in Osteoporosis International (2005, March), 16(Suppl.3), 46

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See detailKnee whole-organ MRI score (WORMS) as a surrogate marker for X-ray joint space narrowing
Bruyère, Olivier ULg; Kothari, M.; Zaim, S. et al

in Osteoporosis International (2005, March), 16(Suppl.3), 6

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See detailRandomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group.
REGINSTER, Jean-Yves ULg; Minne, H. W.; Sorensen, O. H. et al

in Osteoporosis International (2000), 11(1), 83-91

The purpose of this randomized, double-masked, placebo-controlled study was to determine the efficacy and safety of risedronate in the prevention of vertebral fractures in postmenopausal women with ... [more ▼]

The purpose of this randomized, double-masked, placebo-controlled study was to determine the efficacy and safety of risedronate in the prevention of vertebral fractures in postmenopausal women with established osteoporosis. The study was conducted at 80 study centers in Europe and Australia. Postmenopausal women (n = 1226) with two or more prevalent vertebral fractures received risedronate 2.5 or 5 mg/day or placebo; all subjects also received elemental calcium 1000 mg/day, and up to 500 IU/day vitamin D if baseline levels were low. The study duration was 3 years; however, the 2.5 mg group was discontinued by protocol amendment after 2 years. Lateral spinal radiographs were taken annually for assessment of vertebral fractures, and bone mineral density was measured by dual-energy X-ray absorptiometry at 6-month intervals. Risedronate 5 mg reduced the risk of new vertebral fractures by 49% over 3 years compared with control (p<0.001). A significant reduction of 61% was seen within the first year (p = 0.001). The fracture reduction with risedronate 2.5 mg was similar to that in the 5 mg group over 2 years. The risk of nonvertebral fractures was reduced by 33% compared with control over 3 years (p = 0.06). Risedronate significantly increased bone mineral density at the spine and hip within 6 months. The adverse-event profile of risedronate, including gastrointestinal adverse events, was similar to that of control. Risedronate 5 mg provides effective and well-tolerated therapy for severe postmenopausal osteoporosis, reducing the incidence of vertebral fractures and improving bone density in women with established disease. [less ▲]

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See detailRisedronate reverses bone loss in postmenopausal women with low bone mass: results from a multinational, double-blind, placebo-controlled trial. BMD-MN Study Group.
Fogelman, I; Ribot, C; Smith, R et al

in Journal of Clinical Endocrinology and Metabolism (2000), 85(5), 1895-900

Our objective was to investigate the efficacy and tolerability of risedronate in postmenopausal women with low bone mass. Women with a mean lumbar spine T-score of -2 or less (n = 543) received 24 months ... [more ▼]

Our objective was to investigate the efficacy and tolerability of risedronate in postmenopausal women with low bone mass. Women with a mean lumbar spine T-score of -2 or less (n = 543) received 24 months of placebo or risedronate (2.5 or 5 mg/day). All received calcium (1 g/day). The principal outcome measures were bone mineral density (BMD) at the lumbar spine, femoral neck, and femoral trochanter. At 24 months, lumbar spine BMD increased from baseline by 4% with 5 mg risedronate and 1.4% in the 2.5-mg group, compared with no change with placebo. Efficacy was similar in women who were less than 5 yr and more than 5 yr postmenopausal. At 24 months, risedronate (5 mg) had also increased BMD at the femoral neck and trochanter, whereas BMD decreased in the placebo group. BMD increases were seen at all three sites with risedronate (5 mg) after only 6 months of therapy. Risedronate was well tolerated; upper gastrointestinal adverse events were similar to placebo. We conclude that risedronate (5 mg) increases BMD rapidly and effectively and is well tolerated in postmenopausal women with low bone mass, regardless of time since menopause. [less ▲]

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See detailRecommandations for Health Economics Evaluations of interventions in Osteoporosis
Reginster, Jean-Yves ULg; Gathon, Henry-Jean ULg; Marciniak, A. et al

Book published by World Health Organization (1999)

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See detailRisedronate increases bone mineral density and is well-tolerated in postmenopausal women with low bone mineral density
Ribot, C; Smith, R; Fogelman, I et al

in Journal of Bone and Mineral Research (1999), 14(S1), 136

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See detailRisedronate significantly reduces vertebral and non-vertebral fractures in osteoporotic women
Roux, C; Keller, M; Eastell, R et al

in Journal of Bone and Mineral Research (1999), 14(S1), 538

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See detailRisedronate produces dose-dependent increases in bone mineral density in postmenopausal women with low bone mass
Fogelman, I; Ribot, C; Smith, R et al

in Calcified Tissue International (1999), 64(S1), 69

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See detailRisedronate reduces fracture risk in women with established postmenopausal osteoporosis
Eastell, R; Minne, H; Sorensen, O et al

in Calcified Tissue International (1999), 64(S1), 43

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See detailRisedronate reduces hip fractures in patients with low femoral neck bone mineral density
Miller, P; Roux, C; McClung, M et al

in Arthritis and Rheumatism (1999), 42(S1), 287

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See detailRecommendations for the registration of drugs used in the treatment of rheumatoid arthritis
Lemmel, EM; Reid, DM; Nuki, G et al

in British Journal of Rheumatology (1998), 37

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See detailRecommendations for registration of drugs used in the treatment of osteoarthritis
Dougados, M; Devogelaer, JP; Annefeldt, M et al

in Annals of the Rheumatic Diseases (1996), 55

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See detailEvaluation of efficacy and safety of oral tiludronate in Paget's disease of bone: a double-blind, dose-ranging, placebo-controlled study
Reginster, Jean-Yves ULg; Colson, F; Morlock, G et al

in Arthritis and Rheumatism (1993), 36

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