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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00148915 |
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.
Condition | Intervention | Phase |
---|---|---|
Osteoporosis |
Drug: ibandronate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
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 |
Enrollment: | 100 |
Study Start Date: | August 2005 |
Ages Eligible for Study: | 55 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
United States, California | |
GSK Investigational Site | |
Upland, California, United States, 91786 | |
United States, Colorado | |
GSK Investigational Site | |
Boulder, Colorado, United States, 80304 | |
GSK Investigational Site | |
Lakewood, Colorado, United States, 80227 | |
United States, Florida | |
GSK Investigational Site | |
Miami, Florida, United States, 33156 | |
GSK Investigational Site | |
Miami, Florida, United States, 33143 | |
United States, Georgia | |
GSK Investigational Site | |
Atlanta, Georgia, United States, 30308 | |
GSK Investigational Site | |
Decatur, Georgia, United States, 30033 | |
United States, Indiana | |
GSK Investigational Site | |
Indianapolis, Indiana, United States, 46202 | |
United States, Maine | |
GSK Investigational Site | |
Bangor, Maine, United States, 04401 | |
United States, Maryland | |
GSK Investigational Site | |
Bathesda, Maryland, United States, 20817 | |
United States, Michigan | |
GSK Investigational Site | |
Flint, Michigan, United States, 48532 | |
United States, New Mexico | |
GSK Investigational Site | |
Albuquerque, New Mexico, United States, 87106 | |
United States, New York | |
GSK Investigational Site | |
West Haverstraw, New York, United States, 10993 | |
United States, Pennsylvania | |
GSK Investigational Site | |
Duncansville, Pennsylvania, United States, 16635 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | BON103593 |
Study First Received: | September 6, 2005 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00148915 |
Health Authority: | United States: Food and Drug Administration |
Osteoporosis bisphosphonates bone |
Diphosphonates Ibandronic acid Musculoskeletal Diseases |
Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |