Conditions: Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 214
Healthy volunteers: no

Brief summary:
This study will evaluate the safety and treatment effect of 50 mg odanacatib (MK-0822) with Vitamin D versus placebo with Vitamin D in postmenopausal women with low bone density. The primary efficacy hypothesis is that odanacatib will increase aBMD at the lumbar spine compared to placebo at 12 months.

Detailed description:

Arms:
arm 1: Participants receive 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also receive 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg. arm 2: Participants receive matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also receive 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.

Interventions: intervention 1: Odanacatib intervention 2: Placebo intervention 3: Vitamin D3 intervention 4: Calcium supplement
Intervention descriptions: intervention 1: Odanacatib 50 mg tablets, taken orally once weekly for 24 months. intervention 2: Matching placebo tablets to odanacatib taken orally once weekly for 24 months. intervention 3: Vitamin D3 tablets (5600 IU) taken orally once weekly for 24 months. intervention 4: Calcium supplement 500 mg tablet taken orally once daily (up to \~1200 mg total) for 24 months.

Protocol document: