A Research Study to Evaluate the Safety and Effectiveness of MK0217 to Prevent and Treat Bone Loss

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00480766

First received: May 30, 2007

Last updated: November 24, 2009

Last verified: November 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 30, 2007

Last Updated Date

November 24, 2009

Start Date ^ICMJE

July 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Assess the effect of patients taking MK0217 once weekly along with steroids for a 12 month period by checking the percentage change of bone mineral density as compared to patients taking placebo

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00480766 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Describe how safe and tolerable the drug MK0217 is when patients take it once weekly over 3 months

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Research Study to Evaluate the Safety and Effectiveness of MK0217 to Prevent and Treat Bone Loss

Official Title ^ICMJE

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of Oral Alendronate Sodium Once Weekly for the Prevention and Treatment of Glucocorticoid-Induced Bone Loss

Brief Summary

A research study to see how safe and effective MK0217 is when taken weekly for the prevention and treatment of steroid induced bone loss.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Osteoporosis

Intervention ^ICMJE

Drug: MK0217/Duration of Treatment : 12 Months

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

150

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Man or woman aged 18 to 80 years, being treated with oral glucocorticoid (steroid), without vertebral fracture or prior osteoporotic fracture

Exclusion Criteria:

Mentally or legally incompetent, pregnant, alcohol or drug dependence, history of heart disease, kidney disease, hypertension, upper gastrointestinal disease, cancer, being treated with hormone replacement therapy, or life expectancy of less than 3 years

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00480766

Other Study ID Numbers ^ICMJE

2007_560, MK0217-193

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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