A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo - Full Text View

Purpose

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

MedlinePlus related topics:

Osteoporosis

ChemIDplus related topics:

Ibandronate sodium Ibandronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 Outcome Measures:

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

Enrollment:	100
Study Start Date:	July 2005

Eligibility

Ages Eligible for Study:	55 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148915

Locations


United States, California
	GSK Clinical Trials Call Center
	Upland, California, United States, 91786

United States, Colorado
	GSK Clinical Trials Call Center
	Lakewood, Colorado, United States, 80227
	GSK Clinical Trials Call Center
	Boulder, Colorado, United States, 80304

United States, Florida
	GSK Clinical Trials Call Center
	Miami, Florida, United States, 33156
	GSK Clinical Trials Call Center
	South Miami, Florida, United States, 33143
	GSK Clinical Trials Call Center
	West Palm Beach, Florida, United States, 33407

United States, Georgia
	GSK Clinical Trials Call Center
	Atlanta, Georgia, United States, 30308
	GSK Clinical Trials Call Center
	Decatur, Georgia, United States, 30033

United States, Indiana
	GSK Clinical Trials Call Center
	Indianapolis, Indiana, United States, 46202

United States, Maine
	GSK Clinical Trials Call Center
	Bangor, Maine, United States, 04401

United States, Maryland
	GSK Clinical Trials Call Center
	Bethesda, Maryland, United States, 20817

United States, Michigan
	GSK Clinical Trials Call Center
	Flint, Michigan, United States, 48532

United States, Missouri
	GSK Clinical Trials Call Center
	St. Louis, Missouri, United States, 63110

United States, New Mexico
	GSK Clinical Trials Call Center
	Albuquerque, New Mexico, United States, 87106

United States, New York
	GSK Clinical Trials Call Center
	West Haverstraw, New York, United States, 10993

United States, Pennsylvania
	GSK Clinical Trials Call Center
	Duncansville, Pennsylvania, United States, 16635

Sponsors and Collaborators

GlaxoSmithKline

Hoffmann-La Roche

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	BON103593
First Received:	September 6, 2005
Last Updated:	August 27, 2007
ClinicalTrials.gov Identifier:	NCT00148915
Health Authority:	United States: Food and Drug Administration