A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)

• Status: Completed
• Trial end date: 2011-09-15
• Target enrollment: 0
• Participant gender: Female

Summary

The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once weekly will increase bone mineral density at the femoral neck compared to placebo at the end of 24 months.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Has been postmenopausal for at least 5 years

• Has taken or is taking alendronate

• Agrees not to use medications for osteoporosis other than what is provided by the study

Exclusion Criteria:

• Has a history or evidence of hip fracture

• Has a history of cancer within 5 years of screening, except certain skin or cervical cancers.

• Has active parathyroid disease

• Has a history of thyroid disease not adequately controlled by medication

• Is taking anti-seizure medication and has abnormal calcium metabolism

• Has received any bisphosphonate other than alendronate for 20% of the last 3 years, or within 3 months of screening