SAT0463 Effect of Eight Years of Denosumab Treatment in Postmenopausal Women with Osteoporosis: Five-Year Results from the Freedom Extension

Background Denosumab (DMAb) is an approved therapy for the treatment of postmenopausal women with osteoporosis at increased risk for fracture. The effects of DMAb treatment for up to 10 years are being evaluated in the 3-year FREEDOM study and its 7-year extension. Objectives To report the 5-year results of the FREEDOM extension study, representing up to 8 years of continued DMAb treatment. Methods During the extension, all women received 60 mg of DMAb every 6 months and daily calcium and vitamin D. In this analysis, women in the long-term group received 8 years of DMAb (3 years in FREEDOM and 5 years in the extension); women in the cross-over group received 5 years of DMAb (3 years of placebo in FREEDOM and 5 years of DMAb in the extension). Results Of the women who entered the extension, 66% completed the 5th year. With 8 years of DMAb treatment in the long-term group, mean bone mineral density (BMD) continued to increase from FREEDOM baseline for cumulative gains of 18.4% at the lumbar spine (LS) and 8.3% at the total hip (TH) (all p p Conclusions DMAb treatment for up to 8 years was associated with continued increases in BMD, persistent reduction of bone turnover, and low fracture incidence. The benefit/risk profile for DMAb remains favorable. Disclosure of Interest C. Roux Grant/research support: Bongrain, Lilly, MSD, Consultant for: Amgen, MSD, Novartis, S. Papapoulos Consultant for: Amgen, Axsome, Gador, GSK, Merck, Speakers bureau: Amgen, Eli Lilly, GSK, Merck, Novartis, K. Lippuner Consultant for: Amgen, Eli Lilly, MSD, Takeda, UCB, C. Lin Shareholder of: Amgen Inc., Employee of: Amgen Inc., D. Kendler Grant/research support: Amgen, Astalis, Eli Lilly, Novartis, Pfizer, Consultant for: Amgen, Eli Lilly, Merck, Pfizer, Warner Chilcott, Speakers bureau: Amgen, Eli Lilly, Pfizer, E. M. Lewiecki Grant/research support: Amgen, Lilly, Merck, Consultant for: Agnovos, Amgen, Lilly, Merck, Radius Health, M. Brandi Grant/research support: Abiogen, Alexion, Amgen, Bruno, Eli Lilly, Farmaceutici, MSD, Servier, Shire, Stroder, Consultant for: Alexion, Servier, Speakers bureau: NPS, E. Czerwinski Grant/research support: Amgen Inc., Merck Serono, Servier, E. Franek Grant/research support: Amgen, Consultant for: Novartis, Speakers bureau: Amgen, MSD, Novartis, Servier, Teva, P. Lakatos Consultant for: Amgen, Lilly, Servier, Speakers bureau: Amgen, Lilly, Merck, Roche, Servier, Teva, C. Mautalen Consultant for: Merck, Servier, S. Minisola Speakers bureau: Abiogen, Amgen, Bruno Farmaceutici, Eli Lilly, Merck Sharp & Dohme, J.-Y. Reginster Grant/research support: Amgen, Boehringer, Bristol Myers Squibb, Chiltern, Danone, Galapagos, GlaxoSmithKline, Lilly, Merck Sharp & Dohme, Novartis, Organon, Pfizer, Roche, Rottapharm, Servier, Teva, Therabel, Theramex, Consultant for: Amgen, Asahi Kasei, GlaxoSmithKline, IBSA-Genevrier, Lilly, Merckle, Negma, Novartis, NPS, Nycomed-Takeda, Roche, Servier, Theramex, UCB, Wyeth, S. Jensen: None declared, N. Daizadeh Shareholder of: Amgen Inc., Employee of: Amgen Inc., A. Wang Shareholder of: Amgen Inc., Employee of: Amgen Inc., M. Gavin Shareholder of: Amgen Inc., Employee of: Amgen Inc., R. Wagman Shareholder of: Amgen Inc., Employee of: Amgen Inc., H. Bone Grant/research support: Amgen, Merck, Novartis, NPS, Consultant for: Amgen, Merck, Novartis, Noven, Sucampo, Tarsa, Speakers bureau: Amgen DOI 10.1136/annrheumdis-2014-eular.1119