Study to Evaluate Efficacy of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Bone Micro-architecture and Overall Safety in Postmenopausal Women (MK-0822-031)

• Status: Completed
• Trial end date: 2011-03-21
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Calcium; Calcium Carbonate; Calcium, Dietary; Cholecalciferol; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Participant has been postmenopausal for 3 years

• Participant has BMD t-score at the total hip, hip trochanter, femoral neck, or lumbar spine ≥ -1.5 but > -3.5

• Participant has 2 hips that are evaluable by dual-energy X-ray absorptiometry (DXA) and quantitative computed tomography (QCT), e.g. contain no hardware from orthopedic procedures

• Participant is ambulatory

Exclusion Criteria:

• Participant has had a previous hip fracture

• Participant has had >1 prior clinical vertebral fracture AND is a candidate for osteoporosis therapy

• Participant has been treated with oral bisphosphonates, strontium, parathyroid hormone (PTH) or other agents with an effect on bone

• Participant has had metabolic bone disorder other than osteoporosis

• Participant has renal stones, Parkinson's disease, multiple sclerosis (MS) or active parathyroid disease.