NCT01552122

Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)

A Phase III Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density, Tolerability, and Safety in the Treatment of Postmenopausal Women With Osteoporosis Previously Treated With Alendronate

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the therapeutic effects and safety of odanacatib on bone mineral density in osteoporotic postmenopausal women who were previously treated with alendronate.

Conditions

• Osteoporosis
• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Odanacatib	Odanacatib 50 mg compressed tablet will be administered orally, once-a-week, for 24 months
DRUG	Alendronate	Alendronate 70 mg compressed tablets will be administered orally, once-a-week, for 24 months; and a reduced dose of 35 mg will be administered in the same fashion to a subset of women, Japanese participants only, for the same 24-month duration.
OTHER	Placebo (odanacatib)	One compressed tablet administered orally, once-a-week, for 24 months.
DIETARY_SUPPLEMENT	Cholecalciferol (Vitamin D3)	Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.
DIETARY_SUPPLEMENT	Calcium carbonate	Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.
OTHER	Placebo (alendronate)	One compressed tablet administered orally, once-a-week, for 24 months.

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2012-03-13
• Last updated: 2015-08-27