ECTS2013 Poster Presentations Osteoporosis: treatment (64 abstracts)
Effects of odanacatib on BMD and safety in the treatment of osteoporosis in postmenopausal women previously treated with alendronate– a randomized placebo-controlled trial
Roland Chapurlat 1 , Tobias De Villiers 2 , Sydney Bonnick 3 , Alberto Odio 4 , Santiago Palacios 5 , Boyd Scott 6 , Celine Le Bailly De Tilleghem 6 , Carolyn DaSilva 6 , Albert Leung 6 & Deborah Gurner 1,
1INSERM, Lyon, France, 2Mediclinic Panorama, Cape Town, South Africa, 3Clinical Research Center of North Texas, Denton, USA, 4Alta California Medical Group, Simi Valley, USA, 5Instituto Palacios, Madrid, Spain, 6Merck Sharp and Dohme, Whitehouse Station, USA.
Odanacatib (ODN) is an orally-active cathepsin K inhibitor being developed for the treatment of postmenopausal osteoporosis. This study evaluated the effects of ODN 50mg once weekly on BMD, bone turnover markers and safety in patients previously treated with alendronate (ALN).
This was a randomized, double-blind, placebo-controlled, 24-month study. The primary endpoint was % change from baseline at month 24 of femoral neck (FN) BMD. Postmenopausal women (n=243) ≥60 years of age with low BMD T-score at the total hip, FN or trochanter but no history of hip fracture and who have taken ALN for ≥3 years were randomized to receive ODN or placebo. Patients received vitamin D3 and calcium supplementation. BMD was assessed by DXA at baseline, 6, 12 and 24 months. Biochemical markers of bone turnover (sCTx, uNTx, sBSAP and sP1NP) were measured at baseline and 3, 6, 12, 18 and 24 months.
In the ODN group, BMD changes from baseline at 24 months were significantly increased from placebo at the femoral neck, trochanter, total hip and lumbar spine (1.7, 1.8, 0.8, and 2.3%, respectively). In the placebo group, BMD at the femoral neck, trochanter and total hip declined significantly from baseline by month 24 (−0.9, −1.4, and −1.9% respectively).ODN significantly decreased bone resorption marker, u-NTx/Cr, and significantly increased bone formation markers, s-P1NP and s-BSAP, vs. placebo. The increase observed for the bone resorption marker s-CTx with ODN treatment was unexpected. Adverse events were comparable between the twq treatments arms. The overall safety profile appeared similar between ODN and placebo.
In this study ODN provided incremental BMD gains in osteoporotic women following ALN treatment. Biomarker results suggest that ODN decreases bone resorption while preserving bone formation.
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