A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated with Alendronate - Odanacatib Study in Patients Previously Treated with Alendronate

Phase 1

• Conditions: Osteoporosis; MedDRA version: 9.1Level: LLTClassification code 10031285Term: Osteoporosis postmenopausal

• Registration Number: EUCTR2008-008257-30-BE
• Lead Sponsor: Merck Sharp & Dohme (Europe) Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-10
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

>= 60 yrs of age, postmenopausal >= 5 yrs, Prior use of ALN for >= 3 yrs, and BMD t-score at hip <=-2.5 and >-3.5 as assessed by DXA without a history of prior fracture (patients with a prior fracture, excluding hip, the BMD t-score can be <=-1.5 and >-3.5 at any hip site).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

History or evidence of hip fracture, active parathyroid disease, and patient received prior treatment for osteoporosis other than ALN.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified