References of "Libanati, C"
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See detailThe effect of 8 or 5 years of denosumab treatment in postmenopausal women with osteoporosis: results from the FREEDOM Extension study.
PAPAPOULOS, S.; LIPPUNER, K.; ROUX, C. et al

in Osteoporosis International (2015), 26(12), 2773-2783

Summary: The FREEDOM study and its Extension provide long-term information about the effects of denosumab for the treatment of postmenopausal osteoporosis. Treatment for up to 8 years was associated with ... [more ▼]

Summary: The FREEDOM study and its Extension provide long-term information about the effects of denosumab for the treatment of postmenopausal osteoporosis. Treatment for up to 8 years was associated with persistent reduction of bone turnover, continued increases in bone mineral density, low fracture incidence, and a favorable benefit/risk profile. Introduction: This study aims to report the results through year 5 of the FREEDOM Extension study, representing up to 8 years of continued denosumab treatment in postmenopausal women with osteoporosis. Methods : Women who completed the 3-year FREEDOM study were eligible to enter the 7-year open-label FREEDOM Extension in which all participants are scheduled to receive denosumab, since placebo assignment was discontinued for ethical reasons. A total of 4550 women enrolled in the Extension (2343 long-term; 2207 cross-over). In this analysis, women in the long-term and cross-over groups received denosumab for up to 8 and 5 years, respectively. Results Throughout the Extension, sustained reduction of bone turnover markers (BTMs) was observed in both groups. In the long-term group, mean bone mineral density (BMD) continued to increase significantly at each time point measured, for cumulative 8-year gains of 18.4 and 8.3 % at the lumbar spine and total hip, respectively. In the cross-over group, mean BMD increased significantly from the Extension baseline for 5-year cumulative gains of 13.1 and 6.2 % at the lumbar spine and total hip, respectively. The yearly incidence of new vertebral and nonvertebral fractures remained low in both groups. The incidence of adverse and serious adverse events did not increase over time. Through Extension year 5, eight events of osteonecrosis of the jaw and two events of atypical femoral fracture were confirmed. [less ▲]

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See detailPourcentage de femmes atteignant des T-scores de DMO non ostéoporotiques au rachis lombaire (RL) et à la hanche totale (HT) après 8 ans de traitement par denosumab (DMAb)
Ferrari, S.; Libanati, C.; Lin, J. et al

in Revue du Rhumatisme (2015, November), 82(S1), 35-36

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See detailRelationship between total hip BMD T-score and incidence of nonvertebral fracture with up to 8 years of denosumab treatment
FERRARI, S.; LIBANATI, C.; LIN, CJF. et al

in Arthritis and Rheumatology (2015), 67(s10), 487-489

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See detailFurther reductions in nonvertebral fracture rate with long-term denosumab treatment in the FREEDOM open-label extension and influence of hip bone mineral density after 3 years.
FERRARI, S.; ADACHI, J.D.; LUPPUNER, K. et al

in Osteoporosis International (2015), 26

Limited data exist on the efficacy of long-term therapies for osteoporosis. In osteoporotic postmenopausal women receiving denosumab for 7 years, nonvertebral fracture rates significantly decreased in ... [more ▼]

Limited data exist on the efficacy of long-term therapies for osteoporosis. In osteoporotic postmenopausal women receiving denosumab for 7 years, nonvertebral fracture rates significantly decreased in years 4–7 versus years 1–3. This is the first demonstration of a further benefit on fracture outcomes with long-term therapy for osteoporosis. Introduction This study aimed to evaluate whether denosumab treatment continued beyond 3 years is associated with a further reduction in nonvertebral fracture rates. Methods Participants who completed the 3-year placebocontrolled Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months (FREEDOM) study were invited to participate in an open-label extension. The present analysis includes 4,074 postmenopausal women with osteoporosis (n=2,343 long-term; n=1,731 cross-over) who enrolled in the extension, missed ≤1 dose during their first 3 years of denosumab treatment, and continued into the fourth year of treatment. Comparison of nonvertebral fracture rates during years 1–3 of denosumab with that of the fourth year and with the rate during years 4–7 was evaluated. Results For the combined group, the nonvertebral fracture rate per 100 participant-years was 2.15 for the first 3 years of denosumab treatment (referent) and 1.36 in the fourth year (rate ratio [RR]=0.64; 95 % confidence interval (CI)=0.48 to 0.85, p=0.003). Comparable findings were observed in the groups separately and when nonvertebral fracture rates during years 1–3 were compared to years 4–7 in the longterm group (RR=0.79; 95 % CI=0.62 to 1.00, p=0.046). Fracture rate reductions in year 4 were most prominent in subjects with persisting low hip bone mineral density (BMD). Conclusions Denosumab treatment beyond 3 years was associated with a further reduction in nonvertebral fracture rate that persisted through 7 years of continuous denosumab administration. The degree to which denosumab further reduces nonvertebral fracture risk appears influenced by the hip bone density achieved with initial therapy [less ▲]

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See detailPercentage of women achieving non-osteoporotic BMD T-scores at the lumbar spine (LS) and total hip (TH) during up to 8 years of Denosumab (Dmab) treatment
Ferrari, S; Libanati, C; Lin, CJF et al

in Osteoporosis International (2015), 26(S1), 149-150

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See detailPercentage of women achieving non-osteoporotic BMD T-scores at the spine and hip over 8 years of denosumab treatment
Ferrari, S; Libanati, C; Lin, CJF et al

in Arthritis and Rheumatism (2014), 66(11), 986-987

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See detailFurther reduction in nonvertebral fracture rate is observed following 3 years of denosumab treatment: results with up to 7 years in the freedom extension
Ferrari, S; Adachi, JD; Lippuner, K et al

in Osteoporosis International (2014), 25(2), 56

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See detailInhibition de la sclérostine par le romosozumab chez des femmes ménopausées ayant une DMO basse : résultats de l'étude de phase 2
Brown, JP; McClung, MR; Grauer, A et al

in Revue du Rhumatisme (2013), 80(S1), 73

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See detailInhibition of sclerostin with romosozumab in postmenopausal women with low BMD : phase 2 trial results
McClung, M; Grauer, A; Boonen, S et al

in Osteoporosis International (2013), 24(1), 38-39

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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 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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