Strontium ranelate improves osteoarthritis symptoms compared to placebo in patients with knee OA: The SEKOIA studyBruyère, Olivier ; ; et alin Osteoporosis International (2013, April), 24(Suppl.1), 49-51 Detailed reference viewed: 10 (3 ULg) Denosumab treatment of postmenopausal women with osteoporosis for 6 years : results from the first 3 years of the freedom extension; ; et al in Osteoporosis International (2012, March), 23(S2), 76 Detailed reference viewed: 53 (2 ULg) Five years of denosumab exposure in women with postmenopausal osteoporosis: Results from the first two years of the FREEDOM extension.; ; 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 ▲] Detailed reference viewed: 19 (6 ULg) Effects of Strontium ranelate on knee osteoarthritis pain : a responder analysisReginster, Jean-Yves ; ; et alin Arthritis and Rheumatism (2012), 64(S10), 110 Detailed reference viewed: 9 (1 ULg) Treatment of postmenopausal women with osteoporosis for six years with denosumab : three-year results from the freedom extension; ; et al in Annals of the Rheumatic Diseases (2012), 71(3), 588 Detailed reference viewed: 18 (1 ULg) Five-year Denosumab treatment of postmenopausal women with osteoporosis: results from the first two years of the freedom trial extension; ; et al in Osteoporosis International (2011, March), 22(Suppl.1), 107-108 Detailed reference viewed: 91 (6 ULg) Denosumab therapy in postmenopausal women with osteoporosis : results from the first two years of the freedom trial extension; ; et al in Endocrine Reviews (2011), 32 Detailed reference viewed: 39 (1 ULg) A phase 3 study of the efficacy and safety of Denosumab in men with low bone mineral density : design of the ADAMO; ; et al in Journal of Bone and Mineral Research (2011), 26(S1), 511 Detailed reference viewed: 18 (2 ULg) Safety observations from denosumab long-term extension and cross-over studies in postmenopausal women with osteoporosis; ; et al in Journal of Bone and Mineral Research (2011), 26(S1), 22-23 Detailed reference viewed: 42 (1 ULg) Traitement 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; ; et al in Revue du Rhumatisme (2011), 78(S5), 214 Detailed reference viewed: 9 (1 ULg) Treatment of postmenopausal women with osteoporosis for 5 years with denosumab : two-year results from the FREEDOM trial extension; ; et al in Annals of the Rheumatic Diseases (2011), 70(S3), 166-167 Detailed reference viewed: 30 (9 ULg) Extended safety observations from denosumab administration in postmenopausal women from FREEDOM and FREEDOM extension trials; ; et al in Arthritis and Rheumatism (2011), 63(S10), 431-432 Detailed reference viewed: 11 (3 ULg) Long-term denosuamab treatment in postmenopausal women with osteoporosis : results from the first two years of the FREEDOM trial extension; ; et al in Osteoporosis International (2011), 22(S4), 527-528 Detailed reference viewed: 14 (1 ULg) Efficacy of monthly oral ibandronate is sustained over 5 years: the MOBILE long-term extension study.; ; Reginster, Jean-Yves et alin 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 ▲] Detailed reference viewed: 13 (4 ULg) Efficacy of monthly oral ibandronate is maintained over 5 years: The MOBILE LTE study.; ; et al in Osteoporosis International (2009, March), 20(Suppl.1), 15 Detailed reference viewed: 122 (1 ULg) Oral ibandronate (150 mg) continues to be effective and well tolerated when administered monthly: the mobile study long-term extension; ; et al in Osteoporosis International (2007, March), 18(Suppl.1), 135-136 Detailed reference viewed: 3 (0 ULg) Intermittent intravenous (i.v.) ibandronate injections are more effective than an established daily oral regimen: DIVA 2-year results; Reginster, Jean-Yves ; et alin Osteoporosis International (2007, March), 18(Suppl.1), 127 Detailed reference viewed: 2 (0 ULg) Upper gastrointestinal safety and tolerability profile of once-monthly and daily oral ibandronate: mobile 2-year analysis; ; et al in Annals of the Rheumatic Diseases (2006, June), 65(Suppl.II), 415 Detailed reference viewed: 10 (5 ULg) |
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