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OP0248 Responder Analysis of the Effects of Abaloparatide (Parathyroid Hormone Related Peptide) and Teriparatide on Bone Mineral Density in Postmenopausal Women with Osteoporosis: Results of the Active Trial
  1. P.D. Miller1,
  2. G. Hattersley2,
  3. E. Lau3,
  4. P. Alexandersen4,
  5. T. Hala5,
  6. S. Mustatea6,
  7. B.S. Nedergaard7,
  8. A. Krogsaa8,
  9. J. Slessinger9,
  10. C. Zerbini10,
  11. I. Valter11,
  12. Z. Visockiene12,
  13. B. Jendrych13,
  14. C.M. Kulak14,
  15. F. Marquez15,
  16. A.G. Harris2,
  17. G.C. Williams2,
  18. M.-Y. Hu2,
  19. D.M. Black16,
  20. B.J. Riis17,
  21. L. Russo18,
  22. C. Christiansen17
  1. 1Colorado Center for Bone Research, Lakewood CO
  2. 2Radius Health, Waltham MA, United States
  3. 3CCBR, Hong Kong, China
  4. 4CCBR, Vejle, Denmark
  5. 5CCBR, Pardubice, Czech Republic
  6. 6CCBR, Bucharest, Romania
  7. 7CCBR, Aalborg
  8. 8CCBR, Ballerup, Denmark
  9. 9CCBR, Brno, Czech Republic
  10. 10CEPIC, Sao Paulo, Brazil
  11. 11CCBR, Tallinn, Estonia
  12. 12CCBR, Vilnius, Lithuania
  13. 13CCBR, Warsaw, Poland
  14. 14SEMPR, Curitiba, Brazil
  15. 15Palm Springs Research Center, Hialeah FL
  16. 16University of California, San Francisco CA, United States
  17. 17Nordic Bioscience, Herlev, Denmark
  18. 18CCBR, Rio de Janiero, Brazil

Abstract

Background Early gains in total hip BMD are desirable to improve hip strength early in the treatment of osteoporosis.

Objectives To determine if women treated with 18-months of abaloparatide (ABL) were more likely to increase BMD than those treated with either TPTD or placebo (PBO), we performed a responder analysis comparing the percentage of subjects experiencing BMD gains of >3% at all three anatomic sites (total hip (TH), femoral neck (FN), lumbar spine (LS)).

Methods In an 18 month phase 3 study of postmenopausal women aged 50-85 with a T-score ≤-2.5 at the spine or hip with either a prior vertebral or non-vertebral fracture, subjects were randomized to receive the PTHrP analog, ABL (80-μg SC daily), TPTD (20-μg SC daily), or placebo. All subjects were also treated with calcium and vitamin D supplementation per local practice. Treatment comparisons were performed using a 2-sided Chi-square test.

Results 18-months of treatment with ABL (N=824) resulted in significantly greater increases in BMD relative to placebo (N=821) at 6, 12 and 18 months at TH, FN and LS. There were also significantly greater increases in BMD with ABL relative to TPTD (N=818) at TH and FN at 6, 12 and 18 months and at LS at 6 and 12 months. Overall, a significantly higher percentage of patients experienced >3% BMD gain in the ABL group (54%) compared to the PBO group (3.38%, p<0.0001) and the TPTD group (39.7%, p<0.0001) at TH, FN and LS combined. The percentage of subjects with increases in BMD with TPTD was also significantly higher relative to PBO, p<0.0001.

Conclusions In postmenopausal women with osteoporosis, more subjects treated with ABL experienced BMD increases at all 3 sites compared to those treated with TPTD or PBO.

Disclosure of Interest P. Miller Grant/research support from: Radius Health, G. Hattersley Employee of: Radius Health, E. Lau Grant/research support from: Radius Health, P. Alexandersen Grant/research support from: Radius Health, T. Hala Grant/research support from: Radius Health, S. Mustatea Grant/research support from: Radius Health, B. Nedergaard Grant/research support from: Radius Health, A. Krogsaa Grant/research support from: Radius Health, J. Slessinger Grant/research support from: Radius Health, C. Zerbini Grant/research support from: Radius Health, I. Valter Grant/research support from: Radius Health, Z. Visockiene Grant/research support from: Radius Health, B. Jendrych Grant/research support from: Radius Health, C. Kulak Grant/research support from: Radius Health, F. Marquez Grant/research support from: Radius Health, A. Harris Employee of: Radius Health, G. Williams Employee of: Radius Health, M.-Y. Hu Employee of: Radius Health, D. Black Consultant for: Radius Health, B. Riis Consultant for: Radius Health, L. Russo Grant/research support from: Radius Health, C. Christiansen Consultant for: Radius Health

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