A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: ibandronate (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: Relationship between biomarkers and changes in bone quality for one year.
Eligibility
Minimum age: 55 Years.
Maximum age: 80 Years.
Gender(s): Female.
Criteria:
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 and Contacts
GSK Clinical Trials Call Center, Upland, California 91786, United States
GSK Clinical Trials Call Center, Lakewood, Colorado 80227, United States
GSK Clinical Trials Call Center, Boulder, Colorado 80304, United States
GSK Clinical Trials Call Center, Miami, Florida 33156, United States
GSK Clinical Trials Call Center, South Miami, Florida 33143, United States
GSK Clinical Trials Call Center, West Palm Beach, Florida 33407, United States
GSK Clinical Trials Call Center, Atlanta, Georgia 30308, United States
GSK Clinical Trials Call Center, Decatur, Georgia 30033, United States
GSK Clinical Trials Call Center, Indianapolis, Indiana 46202, United States
GSK Clinical Trials Call Center, Bangor, Maine 04401, United States
GSK Clinical Trials Call Center, Bethesda, Maryland 20817, United States
GSK Clinical Trials Call Center, Flint, Michigan 48532, United States
GSK Clinical Trials Call Center, St. Louis, Missouri 63110, United States
GSK Clinical Trials Call Center, Albuquerque, New Mexico 87106, United States
GSK Clinical Trials Call Center, West Haverstraw, New York 10993, United States
GSK Clinical Trials Call Center, Duncansville, Pennsylvania 16635, United States
Additional Information
Starting date: July 2005
Last updated: August 27, 2007
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