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A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053 AM1)

2014-08-27 03:13:48 | BioPortfolio

Summary

The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased BMD (bone mineral density) compared to treatment with placebo. This study will also evaluate the safety and efficacy of odanacatib for male osteoporosis patients.

Description

The original study was divided into two parts, with the primary analysis of endpoints to occur at 24 months and the patients will then remain in the study for an additional 12 months (Part 2). Amendment 1 of the protocol removed the additional 12 month period and the Month 36 BMD analysis was deleted.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Osteoporosis

Intervention

Odanacatib, Placebo for Odanacatib

Status

Completed

Source

Merck Sharp & Dohme Corp.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:48-0400

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Medical and Biotech [MESH] Definitions

Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.

A nonhormonal medication for the treatment of postmenopausal osteoporosis in women. This drug builds healthy bone, restoring some of the bone loss as a result of osteoporosis.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

The mineral component of bones and teeth; it has been used therapeutically as a prosthetic aid and in the prevention and treatment of osteoporosis.

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