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: 9.1 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal

• Registration Number: EUCTR2008-008257-30-FR
• Lead Sponsor: Merck & Co. Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-25
• Study Completion: 2011-09-15
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of treatment on BMD percent change from baseline at the femoral neck site assessed by DXA compared to placebo at the end of 24 months.;Primary end point(s): BMD at hip;Secondary Objective: To evaluate the effect of treatment on BMD percent change from baseline at the trochanter, total hip, lumbar spine and 1/3 distal radius sites assessed by DXA compared to placebo at the end of 24 months. Also, to evaluate the effect of treatment on biochemical markers of bone turnover compared to placebo, and within each treatment group, at the end of 24 months. In addition to evaluate these measurements compared to placebo, and within each treatment group, at the end of 12 months.