Conditions: Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 294
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Participants will receive one Odanacatib 50 mg tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg. arm 2: Participants will receive one Placebo tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg.

Interventions: intervention 1: Odanacatib intervention 2: Placebo for Odanacatib intervention 3: Vitamin D3 intervention 4: Calcium carbonate
Intervention descriptions: intervention 1: One 50 mg tablet once weekly intervention 2: One 50 mg tablet once weekly intervention 3: 5600 IU of open-label Vitamin D3 once weekly intervention 4: Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg

Protocol document: