Five years of denosumab exposure in women with postmenopausal osteoporosis: Results from the first two years of the FREEDOM extension

• DOI: 10.1002/jbmr.1479
• Publication Date: 2011-11-23T15:31:46Z
• Authors: Socrates Papapoulos; Roland Chapurlat; Cesar Libanati; Maria Luisa Brandi; Jacques P Brown; Edward Czerwiński; Marc-Antoine Krieg; Zulema Man; Dan Mellström; Sebastião C Radom...; Jean-Yves Reginster; Heinrich Resch; José A Román Ivorra; Christian Roux; Eric Vittinghoff; Matthew Austin; Nadia Daizadeh; Michelle N Bradley; Andreas Grauer; Steven R Cummings; Henry G Bone
• Keywords: Denosumab; Postmenopausal osteoporosis

Abstract The 3-year FREEDOM trial assessed the efficacy and safety of 60 mg denosumab every 6 months for treatment postmenopausal women with osteoporosis. Participants who completed were eligible to enter an extension continue evaluation up 10 years. For results presented here, from group had 2 more years (long-term group) those placebo exposure (cross-over group). We report bone turnover markers (BTMs), mineral density (BMD), fracture rates, safety. A total 4550 enrolled in (2343 long-term; 2207 cross-over). Reductions BTMs maintained or occurred rapidly following administration. In long-term group, lumbar spine hip BMD increased further, resulting 5-year gains 13.7% 7.0%, respectively. cross-over at (7.7%) (4.0%) during 2-year treatment. Yearly incidences both groups below rates observed projected a “virtual untreated twin” cohort. Adverse events did not increase Two adverse adjudicated as consistent osteonecrosis jaw. Five-year osteoporosis BTM reduction BMD, was associated low favorable risk/benefit profile. © 2012 American Society Bone Mineral Research