A 24-Month Extension to: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Postmenopausal Women with Osteoporosis

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Extrait

For Base Study: To assess the effect of L-001037536 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. For 24 Months Extension: To assess the time course of the resolution of effect on lumbar spine BMD during the 12 month extension following 24 months of treatment with MK 822 once weekly in postmenopausal women with osteoporosis. Extension to 36 months: To assess the resolution of effect at 36 months on lumbar spine BMD following 24 months of treatment with MK-0822 once weekly in post-menopausal women with osteoporosis. Extension to 5 years:To estimate BMD differences at the lumbar spine during years 3-5 in post-menopausal osteoporotic women 5 year open-label extension: 1) To estimate the change from baseline on lumbar spine BMD at years 8 & 10 with MK-0822 in postmenopausal osteoporotic women 2) to assess the safety of treatment with MK-0822 50 mg once weekly for up to 10 years.

Critère d'inclusion

Postmenopausal osteoporosis

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A 24-Month Extension to: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Postmenopausal Wom...