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OP0250 Denosumab Treatment of Postmenopausal Women with Osteoporosis for 7 Years: Clinical Fracture Results from the First 4 Years of the Freedom Extension
  1. C. Roux1,
  2. K. Lippuner2,
  3. H. G. Bone3,
  4. C. Zapalowski4,
  5. S. Minisola5,
  6. E. Franek6,
  7. P. Lakatos7,
  8. D. Kendler8,
  9. E. M. Lewiecki9,
  10. C. Mautalen10,
  11. S. Jensen11,
  12. A. Wang4,
  13. N. Daizadeh4,
  14. R. B. Wagman4,
  15. S. Boonen12
  1. 1Paris Descartes University, Paris, France
  2. 2Bern University Hospital, Bern, Switzerland
  3. 3Michigan Bone and Mineral Clinic, Detroit, MI
  4. 4Amgen Inc., Thousand Oaks, CA, United States
  5. 5Sapienza University, Rome, Italy
  6. 6Central Clinical Hospital MSWiA, Warsaw, Poland
  7. 7Semmelweis University, Budapest, Hungary
  8. 8University of British Columbia, Vancouver, BC, Canada
  9. 9New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, United States
  10. 10Centro de Osteopatias Medicas, Buenos Aires, Argentina
  11. 11CCBR, Ballerup, Denmark
  12. 12Leuven University, Leuven, Belgium

Abstract

Background Denosumab (DMAb) has been shown to decrease the risk for new vertebral, nonvertebral, and hip fractures in the 3-year FREEDOM trial. The FREEDOM open-label extension is evaluating the long-term effects of DMAb treatment for up to 10 years.

Objectives We report the incidence of clinical fractures (nonvertebral and clinical vertebral) from the first 4 years of the extension, representing up to 7 years of DMAb exposure.

Methods During the FREEDOM extension, all participants are scheduled to receive 60 mg DMAb every 6 months and calcium/vitamin D daily. For the analyses presented here, women from the FREEDOM DMAb group received 4 more years of DMAb for a total of 7 years (long-term group); women from the FREEDOM placebo group received 4 years of DMAb (cross-over group). In study year 7, nonvertebral fractures, clinical vertebral fractures, and adverse events (AEs) and serious AEs were collected.

Results Of 5928 women eligible for the extension, 4550 (77%) enrolled (N=2343 long-term; N=2207 cross-over). Yearly incidence of nonvertebral fractures remained low; in the long-term group: 1.4%, 1.2%, 1.6%, and 1.5% for years 4-7 of DMAb treatment, respectively, indicating a continued effect of DMAb; in the cross-over group: 2.5%, 1.9%, 2.2%, and 1.0% for years 1-4 of DMAb treatment, respectively, consistent with the DMAb-treated group in FREEDOM. Yearly clinical vertebral fracture rates also were low (long-term: 0.1%, 0.3%, 0.5%, and 0.1%; cross-over: 0.0%, <0.1%, 0.3%, and 0.2%). Exposure-adjusted AE and SAE rates were similar between the long-term and cross-over groups. Events considered consistent with ONJ were observed in 5 and 3 subjects in the long-term and cross-over groups, respectively. Two femur fracture events considered consistent with atypical femoral fracture were observed (1 long-term, 1 cross-over).

Conclusions Denosumab treatment for up to 7 years continued to show a favorable benefit/risk profile and was associated with a low incidence of clinical (nonvertebral and clinical vertebral) fractures.

Disclosure of Interest C. Roux Grant/research support from: Lilly, Amgen Inc., MSD, Consultant for: Amgen Inc., MSD, Novartis, UCB, Speakers bureau: Amgen Inc., MSD, Novartis, UCB, K. Lippuner Consultant for: Amgen Inc., Eli Lilly, Daiichi Sankyo, MSD, Pfizer, Speakers bureau: Amgen Inc., Eli Lilly, Daiichi Sankyo, MSD, Pfizer, H. Bone Grant/research support from: Amgen Inc., Merck, Novartis, Tarsa, Consultant for: Amgen Inc., Merck, Tarsa, Speakers bureau: Amgen Inc., Merck, Tarsa, C. Zapalowski Shareholder of: Amgen Inc., Employee of: Amgen Inc., S. Minisola Speakers bureau: Abiogen, Amgen Inc., Bruno Farmaceutici, Merck Sharp & Dohme, Nycomed, Novartis, Pfizer, Sigma Tau, E. Franek Consultant for: Amgen Inc., MSD, Novartis, Sanofi-Aventis, Servier, TEVA, Speakers bureau: Amgen Inc., MSD, Novartis, Sanofi-Aventis, Servier, TEVA, P. Lakatos: None Declared, D. Kendler Grant/research support from: Merck, Amgen Inc., Eli Lilly, Novartis, J&J, Roche, Pfizer, Consultant for: Merck, Amgen Inc., Eli Lilly, Novartis, Warner Chilcott, Pfizer, Speakers bureau: Merck, Amgen Inc., Eli Lilly, Novartis, Warner Chilcott, Pfizer, E. Lewiecki Grant/research support from: Amgen Inc., Merck, Eli Lilly, Novartis, Warner Chilcott, GSK, and Genentech, Consultant for: Amgen Inc., Eli Lilly, Novartis, Merck, Warner Chilcott, GSK, and Genentech, Speakers bureau: Amgen Inc., Eli Lilly, Novartis, Merck, Warner Chilcott, GSK, and Genentech, C. Mautalen Consultant for: MSD and Servier, Speakers bureau: MSD and Servier, S. Jensen: None Declared, A. Wang Shareholder of: Amgen Inc., Employee of: Amgen Inc., N. Daizadeh Shareholder of: Amgen Inc., Employee of: Amgen Inc., R. Wagman Shareholder of: Amgen Inc., Employee of: Amgen Inc., S. Boonen Grant/research support from: Amgen Inc., Novartis, Consultant for: Amgen Inc., Novartis, Speakers bureau: Amgen Inc., Novartis

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