References of "Czerwinski, E"
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See detailEight years of denosumab treatment in postmenopausal women with osteoporosis: results from the first five years of the freedom extension
Papapoulos, S; Lippuner, K; Roux, C et al

in Osteoporosis International (2014), 25(2), 46-47

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See detailStrontium ranelate improves osteoarthritis symptoms compared to placebo in patients with knee OA: The SEKOIA study
Bruyère, Olivier ULg; Richette, P; Bellamy, N et al

in Osteoporosis International (2013, April), 24(Suppl.1), 49-51

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See detailDenosumab treatment of postmenopausal women with osteoporosis for 6 years : results from the first 3 years of the freedom extension
Papapoulos, S; Brown, JP; Chapurlat, R et al

in Osteoporosis International (2012, March), 23(S2), 76

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See detailFive years of denosumab exposure in women with postmenopausal osteoporosis: Results from the first two years of the FREEDOM extension.
Papapoulos, S.; Chapurlat, R.; Libanati, C. et al

in Journal of Bone and Mineral Research (2012), 27(3), 694-701

The 3-year FREEDOM trial assessed the efficacy and safety of 60 mg denosumab every 6 months for treatment of postmenopausal women with osteoporosis. Participants who completed FREEDOM were eligible to ... [more ▼]

The 3-year FREEDOM trial assessed the efficacy and safety of 60 mg denosumab every 6 months for treatment of postmenopausal women with osteoporosis. Participants who completed FREEDOM were eligible to enter an extension to continue the evaluation of denosumab efficacy and safety for up to 10 years. For the extension results presented here, women from the FREEDOM denosumab group had 2 more years of denosumab treatment (long-term group) and those from the FREEDOM placebo group had 2 years of denosumab exposure (cross-over group). We report results for bone turnover markers (BTMs), bone mineral density (BMD), fractures rates, and safety. A total of 4550 women enrolled in the extension (2343 long-term; 2207 cross-over). Reductions in BTMs were maintained (long-term group) or occurred rapidly (cross-over group) following denosumab administration. In the long-term group, lumbar spine and total hip BMD increased further, resulting in 5-year gains of 13.7% and 7.0%, respectively. In the cross-over group, BMD increased at the lumbar spine (7.7%) and total hip (4.0%) during the 2-year denosumab treatment. Yearly fracture incidences for both groups were below rates observed in the FREEDOM placebo group and below rates projected for a "virtual untreated twin" cohort. Adverse events did not increase with long-term denosumab administration. Two adverse events in the cross-over group were adjudicated as consistent with osteonecrosis of the jaw (ONJ). Five-year denosumab treatment of women with postmenopausal osteoporosis maintained BTM reduction and increased BMD, and was associated with low fracture rates and a favorable risk/benefit profile. (c) 2011 American Society for Bone and Mineral Research. [less ▲]

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See detailA randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density
Orwoll, E.; Teglbjærg, C. S.; Langdahl, B. L. et al

in Journal of Clinical Endocrinology and Metabolism (2012), 97(9), 3161-3169

Context: Men with low bone mineral density (BMD) were treated with denosumab. Objective: Our objective was to investigate the effects of denosumab compared with placebo in men with low BMD after 1 yr of ... [more ▼]

Context: Men with low bone mineral density (BMD) were treated with denosumab. Objective: Our objective was to investigate the effects of denosumab compared with placebo in men with low BMD after 1 yr of treatment. Design, Subjects, and Intervention: This was a placebo-controlled, phase 3 study to investigate the efficacy and safety of denosumab 60 mg every 6 months vs. placebo in men with low BMD. Main Outcome Measure: The primary endpoint was the percent change from baseline in lumbar spine (LS) BMD at month 12. Results: Of the 242 randomized subjects (mean age 65 yr), 228 (94.2%) completed 1 yr of denosumab therapy. After 12 months, denosumab resulted in BMD increases of 5.7% at the LS, 2.4% at the total hip, 2.1% at the femoral neck, 3.1% at the trochanter, and 0.6% at the one third radius (adjusted P≥0.0144 for BMD percent differences at all sites compared with placebo). Sensitivity analyses done by controlling for baseline covariates (such as baseline testosterone levels, BMD T-scores, and 10-yr osteoporotic fracture risk) demonstrated that the results of the primary endpoint were robust. Subgroup analyses indicate that treatment with denosumab was effective across a spectrum of clinical situations. Treatment with denosumab significantly reduced serum CTX levels at d 15 (adjusted P < 0.0001). The incidence of adverse events was similar between groups. Conclusions: One year of denosumab therapy in men with low BMD was well tolerated and resulted in a reduction in bone resorption and significant increases in BMD at all skeletal sites assessed. Copyright © 2012 by The Endocrine Society. [less ▲]

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See detailEffects of Strontium ranelate on knee osteoarthritis pain : a responder analysis
Reginster, Jean-Yves ULg; Chapurlat, R; Bellamy, N et al

in Arthritis and Rheumatism (2012), 64(S10), 110

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See detailTreatment of postmenopausal women with osteoporosis for six years with denosumab : three-year results from the freedom extension
Chapurlat, R; Papapoulos, S; Brown, JP et al

in Annals of the Rheumatic Diseases (2012), 71(3), 588

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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 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 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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See detailTreatment of postmenopausal women with osteoporosis for 5 years with denosumab : two-year results from the FREEDOM trial extension
Chapurlat, R.; Bone, H. G.; Brandi M L et al

in Annals of the Rheumatic Diseases (2011), 70(S3), 166-167

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See detailExtended safety observations from denosumab administration in postmenopausal women from FREEDOM and FREEDOM extension trials
Brown, J. P.; Bone, H. G.; Chapurlat, R. et al

in Arthritis and Rheumatism (2011), 63(S10), 431-432

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See detailLong-term denosuamab treatment in postmenopausal women with osteoporosis : results from the first two years of the FREEDOM trial extension
Bone, H.; Chapurlat, R.; Brandi, M. et al

in Osteoporosis International (2011), 22(S4), 527-528

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See detailEfficacy of monthly oral ibandronate is sustained over 5 years: the MOBILE long-term extension study.
Miller, P. D.; Recker, R. R.; Reginster, Jean-Yves ULg et al

in Osteoporosis International (2011)

The long-term efficacy and safety of once-monthly ibandronate were studied in this extension to the 2-year Monthly Oral Ibandronate in Ladies (MOBILE) trial. Over 5 years, lumbar spine bone mineral ... [more ▼]

The long-term efficacy and safety of once-monthly ibandronate were studied in this extension to the 2-year Monthly Oral Ibandronate in Ladies (MOBILE) trial. Over 5 years, lumbar spine bone mineral density (BMD) increased from baseline with monthly ibandronate 150 mg (8.4%). Long-term monthly ibandronate is effective and well tolerated for up to 5 years in women with postmenopausal osteoporosis. INTRODUCTION: Once-monthly therapy with ibandronate has been studied for up to 5 years in a long-term extension (LTE) to the 2 year MOBILE trial. METHODS: This multicenter, double-blind extension study of monthly ibandronate involved postmenopausal women who had completed 2 years of the MOBILE core study, with >/=75% adherence. Patients were reallocated, or were randomized from daily therapy, to ibandronate 100 mg monthly or 150 mg monthly for a further 3 years. RESULTS: A pooled intent-to-treat (ITT) analysis of 344 patients receiving monthly ibandronate from the core MOBILE baseline showed increases over 5 years in lumbar spine BMD (8.2% with 100 mg and 8.4% with 150 mg). Three-year data relative to MOBILE LTE baseline in the full ITT population of all 698 patients randomized or reallocated from MOBILE (including those previously on daily treatment) showed, on average, maintenance of proximal femur BMD gains achieved in the core 2-year study, with further small gains in lumbar spine BMD. In general, maintenance of efficacy was also indicated by markers of bone metabolism. CONCLUSIONS: There were no tolerability concerns or new safety signals. Monthly treatment with ibandronate 100 and 150 mg is effective and well tolerated for up to 5 years in women with postmenopausal osteoporosis. [less ▲]

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See detailEfficacy of monthly oral ibandronate is maintained over 5 years: The MOBILE LTE study.
Felsenberg, D.; Czerwinski, E.; Stakkestad, J. et al

in Osteoporosis International (2009, March), 20(Suppl.1), 15

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See detailOral ibandronate (150 mg) continues to be effective and well tolerated when administered monthly: the mobile study long-term extension
Stakkestad, J. A.; Lorenc, R.; Czerwinski, E. et al

in Osteoporosis International (2007, March), 18(Suppl.1), 135-136

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See detailIntermittent intravenous (i.v.) ibandronate injections are more effective than an established daily oral regimen: DIVA 2-year results
Czerwinski, E.; Reginster, Jean-Yves ULg; Jonkanski, I. et al

in Osteoporosis International (2007, March), 18(Suppl.1), 127

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See detailUpper gastrointestinal safety and tolerability profile of once-monthly and daily oral ibandronate: mobile 2-year analysis
Czerwinski, E.; Nuti, R.; Greenwald, M. et al

in Annals of the Rheumatic Diseases (2006, June), 65(Suppl.II), 415

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