ECTS Abstracts (2015) 1 P350

Percentage of women achieving non-osteoporotic BMD T-scores at the spine and hip during up to 8 years of denosumab (Dmab) treatment

S Ferrari1, C Libanati2, C J F Lin2, S Adami3, J P Brown4, F Cosman5, E Czerwinski6, L H de Gregório7, J Malouf8, J-Y Reginster9, N S Daizadeh2, A Wang2, R B Wagman2 & E M Lewiecki10

1Geneva University Hospital, Geneva, Switzerland; 2Amgen Inc., Thousand Oaks, CA, USA; 3University of Verona, Verona, Italy; 4Laval University, CHU de Québec (CHUL) Research Centre, Quebec City, Canada; 5Helen Hayes Hospital, West Haverstraw, NY, USA; 6Krakow Medical Center, Krakow, Poland; 7CCBR, Rio de Janeiro, Brazil; 8Universitat Autònoma de Barcelona, Barcelona, Spain; 9University of Liège, Liège, Belgium; 10New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, USA.

Osteoporosis treatment guidelines currently do not define treatment targets or goals. While absence of BMD loss and fracture are generally considered treatment successes, lack of a negative outcome does not set a real goal for therapy. Potential goals might include reaching a BMD T-score somewhere above –2.5, representing an acceptable level of fracture risk. We report the percentage of women who achieved a range of possible target BMD T-scores at both the lumbar spine (LS) and total hip (TH) during up to 8 years of continuous DMAb treatment. Women received 3 years of DMAb (60 mg SC Q6M) during FREEDOM and up to 5 years of DMAb during the Extension for up to 8 years continuous treatment. The percentages of women achieving BMD T-scores >−2.5, >−2.0 and >−1.5 at both the LS and TH, and T-scores >−2.5 at either site over 8 years were determined. Among FREEDOM Extension participants (N=2343), mean (SD) LS and TH T-scores were −2.83 (0.67) and −1.85 (0.79), respectively, at FREEDOM baseline. The percentage of women with BMD T-scores >−2.5, >−2.0, and >−1.5 at both the LS and TH progressively increased over 8 years of DMAb treatment (Table).

Percentage of women achieving non-osteoporotic BMD T-scores at LS and TH.

Baseline (%)Year 3 (%)Year 4 (%)Year 5 (%)Year 6 (%)Year 8 (%)

From baseline through 8 years of DMAb treatment, the percentage of women with a BMD T-score >–2.5 increased from 19% to 86% at LS and from 75% to 94% at TH. In conclusion, DMAb enabled a substantial proportion of women with osteoporosis to achieve non-osteoporotic BMD T-scores. Furthermore, the BMD T-scores achieved at the hip during denosumab treatment are a robust predictor of the subsequent non-vertebral fracture risk, and suggest that achieving T-scores of -2.0 or higher are desirable to maximise treatment efficacy. These data contribute insightful information to discussions on the topic of treatment goals for osteoporosis.

Disclosure: CL, AW, RW, CL, ND -Amgen employees. SA, JB, FC, EL, EZ, LG, JM, JR, SC received financial support from one or more BMS, Merck, Teva, Roche, Amgen, EliLilly, Novartis, GSK, Servier, Theramex, Pfizer, Danone, Organon, Therabel, Boehringer, Chiltern, Galapagos, Teva, Merckle, Teijin, Analis, Nycomed, Ebewee Pharma, Zodiac, WillPharma, Rottapharm, IBSA, Genevrier, Takeda, Negma, Wyeth, AsahiKasei, Roche, Abiogen, AbbVie, Jansen, Radius Health. Amgen Inc provided funding for this study.