A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053)

A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) in the Treatment of Men With Osteoporosis Treated With Vitamin D and Calcium

The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased bone mineral density (BMD) compared to treatment with placebo. This study will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants.

The original study was divided into two parts, with the primary analysis of endpoints to occur at 24 months and participants will then remain in the study for an additional 12 months (Part 2). Amendment 1 of the protocol removed the additional 12 month period and the Month 36 BMD analysis was deleted.

Inclusion Criteria:

• Is a male between 40 and 95 years of age
• Has osteoporosis
• Has anatomy suitable for dual energy x-ray absorptiometry (DXA) scan of the lumbar spine and and hip
• Is ambulatory

Exclusion Criteria:

• Is currently on oral bisphosphonates or other treatment for osteoporosis
• Had previous hip fragility fracture and is a candidate for standard of care therapy
• Has had a fragility fracture (vertebral or non-vertebral fractures indicating reduced bone strength) within 12 months
• Has had more then one previous vertebral fracture
• Has been diagnosed with metabolic bone disorder other than osteoporosis
• Is Vitamin D deficient
• Has a history of renal stones
• Has active parathyroid disease
• Has history of thyroid disease not well controlled by medication
• Is diagnosed with secondary osteoporosis
• Has a daily calcium intake of <1,200 mg and is unwilling to take study prescribed supplements or increase dietary intake, such that his daily calcium intake is at least 1200 mg
• Has a history of malignancy ≤5 years prior to signing informed consent
• Has been diagnosed with hypogonadism due to causes that affect multiple organ and body systems