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Abstract Number: 920

Randomized Controlled Trial to Assess the Safety and Efficacy of Odanacatib in the Treatment of Men with Osteoporosis

Eric Orwoll1, Silvano Adami2, Neil Binkley3, Roland Chapurlat4, Bente Langdahl5, Steven Doleckyj6, Hilde Giezek7, Boyd Scott8 and Arthur Santora8, 1Oregon Health and Science University, Portland, OR, 2Rheumatology Department, University of Verona, Verona, Italy, 3University of Wisconsin, Madison, WI, 4Pavillon F Rheumatology, Hopital Edouard Herriot, Lyon, France, 5Aarhus University Hospital, Aarhus, Denmark, 6Merck & Co., Inc., Whitehouse Station, NJ, 7MSD Belgium, Brussels, Belgium, 8Merck Sharp & Dohme Corp., Whitehouse Station, NJ

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Biomarkers, bone density and osteoporosis

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Session Information

Title: Osteoporosis and Metabolic Bone Disease - Clinical Aspects and Pathogenesis: Clinical Osteoporosis: Treatment and Safety

Session Type: Abstract Submissions (ACR)

Background/Purpose 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 50mg once-weekly resulted in increases in bone mineral density (BMD) vs. baseline at the lumbar spine (LS) (11.9%) and total hip (TH) (8.5%) over 5 years. In this 2-yr 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 50mg ODN or PBO orally once-weekly, and all received vitamin D3(5600IU/week) and calcium supplements (total intake including food of ~1200mg daily). The primary outcomes were the effect of ODN versus PBO on LS BMD assessed by DXA versus 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, S-CTx, 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 250ng/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<0.01; FN p=0.008). ODN significantly decreased (vs. PBO) the bone resorption markers u-NTx/Cr and s-CTx (68% and 77%, both p<0.001) and also decreased bone formation markers, s-PINP and s-BSAP (16% and 8%, p=0.001 and p=0.019 respectively) compared to PBO at 24-months. The between group decrease of bone formation markers was maximal at 3 months, after which levels returned towards baseline by 24 months. The adverse events and overall safety profile were similar between ODN and PBO.

Conclusion

In this study, ODN increased spine and hip BMD in osteoporotic men. Changes in bone turnover markers suggest that ODN treatment decreases bone resorption while producing relatively small decreases in bone formation by the end of the study. ODN is a promising potential therapy for the treatment of osteoporosis in men.


Disclosure:

E. Orwoll,

Merck Human Health,

2;

S. Adami,

Amgen, Eli-Lilly, Abiogen, Roche, Merck,

5;

N. Binkley,

Merck Pharmaceuticals,

2,

Merck Human Health,

5;

R. Chapurlat,
None;

B. Langdahl,

Merck, Amgen, Lilly,

5,

Amgen, Lilly, Merck,

2,

Merck, Amgen, Lilly,

8;

S. Doleckyj,

Merck Human Health,

1,

Merck Human Health,

3;

H. Giezek,

Merck Pharmaceuticals,

1,

Merck Human Health,

3;

B. Scott,

Merck Pharmaceuticals,

1,

Merck Pharmaceuticals,

3;

A. Santora,

Merck Human Health,

1,

Merck Pharmaceuticals,

3.

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