Osteoporos Int (2014) 25:571–581 DOI 10.1007/s00198-014-2891-2
IOF Regionals – 5th Asia-Pacific Osteoporosis Meeting Oral Communications
# International Osteoporosis Foundation and National Osteoporosis Foundation 2014
OC1 RANDOMIZED CONTROLLED TRIAL TO ASSESS THE SAFETY AND EFFICACY OF ODANAC ATIB IN THE TREATMENT OF MEN WITH OSTEOPOROSIS E. Orwoll1,*, A. Silvano2, N. Binkley3, R. Chapurlat4, B. Langdahl5, S. Doleckyj6, H. Giezek7, B. B. Scott6, A. Santora6 1 Oregon Health & Science University, Portland, USA, 2University of Verona, Verona, Italy, 3University of Wisconsin School of Medicine and Public Health, WI, USA, 4INSERM UMR 1033, Université de Lyon, Hôpital E Herriot, Lyon, France, 5Aarhus University Hospital, Aarhus, Denmark, 6 Merck & Co. Inc., Whitehouse Station, USA, 7MSD Brussels, Brussels, Belgium Aims: Osteoporosis in men is an important clinical problem, associated with significant morbidity, mortality and societal expense. Men with osteoporosis represent between 20 and 25 % of all osteoporotic patients and men are at greater risk of death following a hip fracture. Odanacatib (ODN), a selective inhibitor of cathepsin K, is currently being investigated as a treatment for osteoporosis. In a phase II study in postmenopausal women, treatment with ODN 50 mg once-weekly resulted in increases in BMD vs. baseline at the lumbar spine (LS) (11.9 %) and total hip (TH) (8.5 %) over 5 years. In this 2-years phase III study safety and efficacy of ODN in the treatment of men with osteoporosis was investigated. Methods: This was a double-blind, randomized; placebo controlled 24-month trial. Men ≥40 and ≤95 years of age with idiopathic osteoporosis or osteoporosis due to hypogonadism were enrolled. Inclusion criteria included a LS or hip (TH, femoral neck (FN) or trochanter) T-score of≤−2.5 to≥−4.0 without prior vertebral fracture or≤−1.5 to≥−4.0 with one prior vertebral fracture. Participants were randomized (1:1) to 50 mg ODN or PBO orally once-weekly, and all received vitamin D3 (5,600 IU/week) and calcium supplements (total
intake including food of ~1,200 mg daily). The primary outcomes were the effect of ODN vs. PBO on LS BMD assessed by DXA vs. PBO at 24 months and safety and tolerability. Secondary outcomes included changes in BMD at the TH, FN, trochanter sites, and bone turnover markers (u-NTx, SCTx, s-PINP and s-BSAP). Results: A total of 292 men were randomized and received at least one dose of study medication. The average age was 68.8 years, and 5.8 % had total testosterone levels below 250 ng/dL. BMD increases from baseline at 24 months in the ODN group at the LS and all 3 hip sites (TH, FN and trochanter) were 6.9 %, 1.9 %, 1.7 % and 2.8 %, respectively, and all were greater vs. PBO (LS, TH and trochanter p
IOF Regionals – 5th Asia-Pacific Osteoporosis Meeting Oral Communications
# International Osteoporosis Foundation and National Osteoporosis Foundation 2014
OC1 RANDOMIZED CONTROLLED TRIAL TO ASSESS THE SAFETY AND EFFICACY OF ODANAC ATIB IN THE TREATMENT OF MEN WITH OSTEOPOROSIS E. Orwoll1,*, A. Silvano2, N. Binkley3, R. Chapurlat4, B. Langdahl5, S. Doleckyj6, H. Giezek7, B. B. Scott6, A. Santora6 1 Oregon Health & Science University, Portland, USA, 2University of Verona, Verona, Italy, 3University of Wisconsin School of Medicine and Public Health, WI, USA, 4INSERM UMR 1033, Université de Lyon, Hôpital E Herriot, Lyon, France, 5Aarhus University Hospital, Aarhus, Denmark, 6 Merck & Co. Inc., Whitehouse Station, USA, 7MSD Brussels, Brussels, Belgium Aims: Osteoporosis in men is an important clinical problem, associated with significant morbidity, mortality and societal expense. Men with osteoporosis represent between 20 and 25 % of all osteoporotic patients and men are at greater risk of death following a hip fracture. Odanacatib (ODN), a selective inhibitor of cathepsin K, is currently being investigated as a treatment for osteoporosis. In a phase II study in postmenopausal women, treatment with ODN 50 mg once-weekly resulted in increases in BMD vs. baseline at the lumbar spine (LS) (11.9 %) and total hip (TH) (8.5 %) over 5 years. In this 2-years phase III study safety and efficacy of ODN in the treatment of men with osteoporosis was investigated. Methods: This was a double-blind, randomized; placebo controlled 24-month trial. Men ≥40 and ≤95 years of age with idiopathic osteoporosis or osteoporosis due to hypogonadism were enrolled. Inclusion criteria included a LS or hip (TH, femoral neck (FN) or trochanter) T-score of≤−2.5 to≥−4.0 without prior vertebral fracture or≤−1.5 to≥−4.0 with one prior vertebral fracture. Participants were randomized (1:1) to 50 mg ODN or PBO orally once-weekly, and all received vitamin D3 (5,600 IU/week) and calcium supplements (total
intake including food of ~1,200 mg daily). The primary outcomes were the effect of ODN vs. PBO on LS BMD assessed by DXA vs. PBO at 24 months and safety and tolerability. Secondary outcomes included changes in BMD at the TH, FN, trochanter sites, and bone turnover markers (u-NTx, SCTx, s-PINP and s-BSAP). Results: A total of 292 men were randomized and received at least one dose of study medication. The average age was 68.8 years, and 5.8 % had total testosterone levels below 250 ng/dL. BMD increases from baseline at 24 months in the ODN group at the LS and all 3 hip sites (TH, FN and trochanter) were 6.9 %, 1.9 %, 1.7 % and 2.8 %, respectively, and all were greater vs. PBO (LS, TH and trochanter p
