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COMPLETEDPHASE1

Safety and Tolerability of Odanacatib (0822-059)

A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Odanacatib (MK0822) in Healthy Male and Postmenopausal Female Subjects

NCT01068262•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This study will test the weighted average inhibition of u-NTx/Cre (aminoterminal crosslinked telopeptide of Type 1 collagen) and AUC (0-168 hours) of Odanacatib

Eligibility

Age

45 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•male subject between the ages of 50 and 75 years; post menopausal female subjects between the ages of 45 and 75 years
•Subject is in good general health
•Subject has no evidence of metabolic bone disorder other than osteopenia or osteoporosis
•Subject is a non-smoker

Exclusion Criteria

•Subject works night shift and is unable to avoid nightshift work during the study
•Subject has had major surgery, donated blood or participated in another investigational study with in the past 4 weeks
•Subject has a history of stroke, chronic seizures, or major neurological disease
•Subject has a history of cancer
•Subject consumes excessive amounts of alcohol or caffeine

Key Dates

Start Date

December 8, 2009

Primary Completion Date

April 26, 2010

Completion Date

May 2, 2010

Last Updated

August 28, 2018

Enrollment

ACTUAL participants

Conditions

Osteoporosis

Interventions

Odanacatib

DRUG

Comparator: Placebo

DRUG

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

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OsteoporosisLower Limb Fracture

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RECRUITINGPHASE4

Step-down Therapy After Long-term Osteoporosis Treatment

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Osteoporosis

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Tolerability of Odanacatib (0822-059)

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

Step-down Therapy After Long-term Osteoporosis Treatment

Smart Wearable Device (gaitQ): Walk Better Project

Automated Bone Age Estimation From Noncontrast Abdominal CT Using Deep Learning

Effect of Mechanical Loading and Bone Loss on Motor Neuron Activity-H-Reflex Relationship

Clinical Study to Estimate Bone Mineral Density With the POROUS Ultrasound Device