Reference : Five years of denosumab exposure in women with postmenopausal osteoporosis: Results from...
Scientific journals : Article
Human health sciences : General & internal medicine
http://hdl.handle.net/2268/107712
Five years of denosumab exposure in women with postmenopausal osteoporosis: Results from the first two years of the FREEDOM extension.
English
Papapoulos, S. [> > > >]
Chapurlat, R. [> > > >]
Libanati, C. [> > > >]
Brandi, M. [> > > >]
Brown, J. [> > > >]
Czerwinski, E. [> > > >]
Krieg, M. A. [> > > >]
Man, Z. [> > > >]
Mellstrom, D. [> > > >]
Radominski, S. [> > > >]
Reginster, Jean-Yves mailto [Université de Liège - ULg > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé]
Resch, H. [> > > >]
Roman, J. [> > > >]
Roux, C. [> > > >]
Vittinghoff, E. [> > > >]
Austin, M. [> > > >]
Daizadeh, N. [> > > >]
Bradley, M. [> > > >]
Grauer, A. [> > > >]
Cummings, S. [> > > >]
Bone, H. [> > > >]
Mar-2012
Journal of Bone and Mineral Research
American Society for Bone and Mineral Research
27
3
694-701
Yes (verified by ORBi)
International
0884-0431
1523-4681
Washington
DC
[en] 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.
http://hdl.handle.net/2268/107712
10.1002/jbmr.1479
Copyright (c) 2011 American Society for Bone and Mineral Research.

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