A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00148915

First received: September 6, 2005

Last updated: October 15, 2008

Last verified: October 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

October 15, 2008

Start Date ^ICMJE

August 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Bone quality and strength at the hip by characterizing changes in trabecular and cortical bone quality using Volumetric Quantitative Computed Tomography (vQCT) and novel imaging analysis methods, including a subset of bone biopsies for one year. [ Time Frame: 1 Year ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00148915 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Relationship between biomarkers and changes in bone quality for one year. [ Time Frame: 1 Year ]

Original Secondary Outcome Measures ^ICMJE

Relationship between biomarkers and changes in bone quality.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo

Official Title ^ICMJE

A One Year, Parallel, Placebo-Controlled, Double-Blind, Randomized Study to Assess the Effect of Monthly 150mg Oral Ibandronate Dosing Versus Placebo on Bone Quality and Strength at the Proximal Femur in Women With Osteoporosis

Brief Summary

The purpose of this study is to estimate the effect of oral Boniva (ibandronate sodium)taken once monthly versus placebo on bone quality and strength at the hip at one year.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Osteoporosis

Intervention ^ICMJE

Drug: ibandronate

Other Name: ibandronate

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

100

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion criteria:

Ambulatory, postmenopausal women who are diagnosed with osteoporosis.
Must be able to stand or sit upright for at least 60 minutes and swallow a tablet whole.

Exclusion criteria:

Have been treated with other bisphosphonates or using chronic steroids within the past 6 months.
Have a history of major upper GI diseases or have severe kidney dysfunction.
Have a spine fracture (identified on x-ray).

Gender

Female

Ages

55 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00148915

Other Study ID Numbers ^ICMJE

BON103593

Has Data Monitoring Committee

Not Provided

Responsible Party

Study Director, GSK

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

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

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