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FOUR-YEAR RESULTS OF A PHASE 2 STUDY OF THE CATHEPSIN K INHIBITOR ODANACATIB IN POSTMENOPAUSAL WOMEN WITH LOW BONE MINERAL DENSITY

V Środkowo Europejski Kongres Osteoporozy i Osteoartrozy oraz XVII Zjazd Polskiego Towarzystwa Osteoartrologii i Polskiej Fundacji Osteoporozy, Kraków 29.09-1.10.2011

Streszczenia:
Ortopedia Traumatologia Rehabilitacja 2011, vol 13 (Suppl. 1). str 78

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FOUR-YEAR RESULTS OF A PHASE 2 STUDY OF THE CATHEPSIN K INHIBITOR ODANACATIB IN POSTMENOPAUSAL WOMEN WITH LOW BONE MINERAL DENSITY

Lorenc R.S.1, Binkley N.2, Bone H.3, Eisman J.4, Hosking D.5, Langdahl B.6, McClung M.7, Reid I.8, Resch H.9, Rodriguez Portales J.10, Petrovic R.11, Rosenberg E.12, DaSilva C.12, Santora A.12, Lombardi A.12

1Children Health Institute,Warsaw, Poland

2Osteoporosis Clinical Center and Research Program and Institute on Aging, University of Wisconsin, Madison, WI, USA

3Michigan Bone and Mineral Center, Detroit, Michigan, USA

4Garvan Institute of Medical Research, St Vincent’s Hospital, UNSW, Sydney, NSW, Australia

5Nottingham City Hospital, Nottingham, UK

6Department of Endocrinology, Aarhus University Hospital, Aarhus, Denmark

7Oregon Osteoporosis Center, Portland, Oregon

8University of Auckland, Auckland, New Zealand

9St. Vincent Hospital, Vienna, Austria

10Department of Endocrinology, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile

11Merck Research Laboratories, Brussels, Belgium

12Merck Research Laboratories, Rahway, NJ, USA

Aim. Cathepsin K (CatK) is the primary collagenase in osteoclasts. In a 2-year phase 2 study and its 1-year extension, the selective cathepsin K inhibitor odanacatib (ODN) reduced bone resorption markers and progressively increased bone mineral density (BMD). The study was extended for 2 additional years to further assess ODN efficacy and long-term safety.

Methods. Postmenopausal women with BMD T-scores between -2.0 and -3.5 at the lumbar spine, femoral neck, trochanter or total hip received placebo or ODN at 3, 10, 25 or 50 mg weekly during the 2-year study. In Year 3, participants were re-randomized to ODN 50 mg weekly or placebo. In Years 4/5, women who received placebo or 3 mg ODN in Years 1/2 and placebo in Year 3 were switched to 50 mg ODN for Years 4/5; all others continued with their Year 3 regimen. 141 women entered the extension, and 133 completed 4 years. Endpoints were BMD at the lumbar spine (primary), total hip and hip subregions, and 1/3 radius; levels of biochemical bone turnover markers; and assessments of safety.

Results. During year 4, 100 women received 50 mg ODN and 41 received placebo. Continuous treatment with 50 mg ODN for 4 years induced significant BMD increases from baseline at the spine (10.7%), total hip (8.3%), femoral neck (8.9%), and trochanter (10.3%) and maintained BMD (-0.1%) at the 1/3 radius; BMD changes from Year 3 were 2.8% (spine), 2.5% (total hip), 3.9% (femoral neck), and 2.9% (trochanter). Serum CTX remained low at Year 4 (-41%), whereas BSAP was relatively unchanged (-2%) from baseline. Women who received active treatment for 2 years and switched to placebo for 2 years experienced bone loss, with BMD near baseline for most sites and decreased by 4.5% at the 1/3 radius at the end of Year 4. Levels of bone turnover markers in women who discontinued active treatment after 2 years rose in the first month off-treatment, but all levels returned to baseline by the end of Year 4. ODN was generally well tolerated.

Conclusions. 4 years of ODN treatment increased lumbar spine and hip BMD and was generally well-tolerated in postmenopausal women with low bone mass. Bone formation markers remained relatively unaffected. Discontinuation of ODN after 2 years of treatment was promptly followed by resolution of effects on bone turnover and density such that BMD and bone biomarker levels at Year 4 were at or near baseline.

 

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Wyniki czteroletniego badania 2 fazy odanakatibu, inhibitora katepsyny, u kobiet pomenopauzalnych z niskim BMD

Lorenc R.S.1, Binkley N.2, Bone H.3, Eisman J.4, Hosking D.5, Langdahl B.6, McClung M.7, Reid I.8, Resch H.9, Rodriguez Portales J.10, Petrovic R.11, Rosenberg E.12, DaSilva C.12, Santora A.12, Lombardi A.12

1 Zakład Biochemii i Medycyny Doświadczalnej, Instytut „Pomnik – Centrum Zdrowia Dziecka”, Warszawa

 2Osteoporosis Clinical Center and Research Program and Institute on Aging, University of Wisconsin, Madison, WI, USA

3Michigan Bone and Mineral Center, Detroit, Michigan, USA

4Garvan Institute of Medical Research, St Vincent’s Hospital, UNSW, Sydney, NSW, Australia

5Nottingham City Hospital, Nottingham, UK

6Department of Endocrinology, Aarhus University Hospital, Aarhus, Denmark

7Oregon Osteoporosis Center, Portland, Oregon

8University of Auckland, Auckland, New Zealand

9St. Vincent Hospital, Vienna, Austria

10Department of Endocrinology, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile

11Merck Research Laboratories, Brussels, Belgium

12Merck Research Laboratories, Rahway, NJ, USA

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