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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-07-31

Brief Summary

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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

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Conditions

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Osteoporosis

Keywords

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Osteoporosis bisphosphonates bone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ibandronate

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

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Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

ibandronate

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

GlaxoSmithKline

Responsible Party

Principal Investigators

GSK Clinical Trials

Locations

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

Countries

Study Documents

Document Type: Individual Participant Data Set

Document Type: Clinical Study Report

Document Type: Statistical Analysis Plan

Document Type: Informed Consent Form

Document Type: Annotated Case Report Form

Document Type: Study Protocol

Document Type: Dataset Specification

Related Links

Other Identifiers

BON103593