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See detailThe risk of subsequent osteoporotic fractures is decreased in subjects experiencing fracture while on denosumab: results from the FREEDOM and FREEDOM Extension studies
Kendler, D.L.; Chines, A.; Brandi, M.L. et al

in Osteoporosis International (2019), 30(1), 71-78

Summary: This post-hoc analysis queried whether women experiencing fracture on denosumab indicates inadequate treatment response or whether the risk of subsequent fracture remains low with continuing ... [more ▼]

Summary: This post-hoc analysis queried whether women experiencing fracture on denosumab indicates inadequate treatment response or whether the risk of subsequent fracture remains low with continuing denosumab. Results showed that denosumab decreases the risk of subsequent fracture and fracture sustained while on denosumab is not necessarily indicative of inadequate treatment response. Introduction: This analysis assessed whether a fracture sustained during denosumab therapy indicates inadequate treatment response and if the risk of a subsequent fracture decreases with continuing denosumab treatment. Methods: In FREEDOM, a clinical trial to evaluate the efficacy and safety of denosumab, postmenopausal women with osteoporosis were randomized to placebo or denosumab for 3 years. In the 7-year FREEDOM Extension, all participants were allocated to receive denosumab. Here we compare subsequent osteoporotic fracture rates between denosumabtreated subjects during FREEDOM or the Extension and placebo-treated subjects in FREEDOM. Results: During FREEDOM, 438 placebo- and 272 denosumab-treated subjects had an osteoporotic fracture. Exposure-adjusted subject incidence per 100 subject-years was lower for denosumab (6.7) vs placebo (10.1). Combining all subjects on denosumab from FREEDOM and the Extension for up to 10 years (combined denosumab), 794 (13.7%) had an osteoporotic fracture while on denosumab. Of these, one or more subsequent fractures occurred in 144 (18.1%) subjects, with an exposure-adjusted incidence of 5.8 per 100 subject-years, similar to FREEDOM denosumab (6.7 per 100 subject-years) and lower than FREEDOM placebo (10.1 per 100 subjectyears). Adjusting for prior fracture, the risk of having a subsequent on-study osteoporotic fracture was lower in the combined denosumab group vs placebo (hazard ratio [95% CI]: 0.59 [0.43–0.81]; P = 0.0012). Conclusions: These data demonstrate that denosumab decreases the risk of subsequent fracture and a fracture sustained while on denosumab is not necessarily indicative of inadequate treatment response. [less ▲]

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See detail10 years of denosumab treatment in postmenopausal women with osteoporosis: results from the phase 3 randomised FREEDOM trial and open-label extension
Bone, H.G.; Wagman, R.B.; Brandi, M.L. et al

in Lancet Diabetes and Endocrinology (2017), 5

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See detailThe risk of subsequent osteoporotic fractures is decreased in patients experiencing fracture while on denosumab: results from the FREEDOM and FREEDOM Extension studies.
Kendler, D.L.; Chines, A.; Brandi, M.L. et al

in Osteoporosis International (2017, March), 28 Suppl 1

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See detailThe risk of subsequent osteoporotic fractures is decreased in patients experiencing fracture while on denosumab.
Kendler, D.L.; Chines, A.; Brandi, M.L. et al

in Arthritis and Rheumatism (2016, September), 68S10

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See detailTen years of Denosumab (DMAB) treatment in postmenopausal women with osteoporosis. Results from the FREEDOM Extension trial.
Bone, H.G.; Brandi, M.L.; Brown, J.P. et al

in Osteoporosis International (2016, April), 27(Supplement 1), 135-136

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See detailA randomized double-blind study of Denosumab (DMAB) compared with Zoledronic acid (ZOL) in postmenopausal women with osteoporosis previously treated with oral bisphosphonates
Miller, P.; Pannacciulli, N.; Brown, J.P. et al

in Osteoporosis International (2016, April), 27(SUPPLEMENT1), 42

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See detailA randomized double-blind study of denosumab compared with zoledronic acid in postmenopausal women with osteoporosis previously treated with oral bisphosphonate.
MILLER, P.D.; PANNACCIULLI, N.; BROWN, J.P. et al

in Arthritis and Rheumatology (2016), 67(S10), 1181-1182

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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 detailDenosumab treatment in postmenopausal women with osteoporosis for up to 9 years: results through year 6 of the freedom extension
Papapoulos, S; Roux, C; Bone, HG et al

in Osteoporosis International (2015), 26(S1), 37-39

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See detailOcanacatib antifracture efficacy and saftey in postmenopausal women with osteoporosis: results from the phase III long-term adonacatib fracture trial (LOFT)
McClung, MR; Langdahl, B; Papapoulos, S et al

in Osteoporosis International (2015), 26(S1), 35-36

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See detailSafety and tolerability of odanacatib therapy in postmenopausal women with osteoporosis: results from the phase III long-term odanacatib fracture trial
Papapoulos, S; McClung, MR; Langdahl, B et al

in Osteoporosis International (2014), 25(5), 604-605

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See detailOdanacatib anti-fracture efficacy and safety in postmenopausal women with osteoporosis: results from the phase III long-term odanacatib fracture trial
McClung, MR; Langdahl, B; Papapoulos, S et al

in Osteoporosis International (2014), 25(5), 573-575

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See detailOdanacatib anti-fracture efficacy and safety in postmenopausal women with osteoporosis: results from the phase III long-term odanacatib fracture trial
McClung, MR; Langdahl, B; Papapoulos, S et al

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

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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 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 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 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 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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