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

GlaxoSmithKline100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Osteoporosis

Interventions

ibandronateDRUG

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

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).

Locations (15)

GSK Investigational Site

Upland, California, United States

GSK Investigational Site

Boulder, Colorado, United States

GSK Investigational Site

Outcomes

Primary Outcomes

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

Secondary Outcomes

Relationship between biomarkers and changes in bone quality for one year.

Time frame: 1 Year

Data from ClinicalTrials.gov

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