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

Further Study Details: 

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.
Secondary Outcomes: Relationship between biomarkers and changes in bone quality.
Expected Total Enrollment:  100

Ages Eligible for Study:  55 Years   -   80 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion criteria:

• Ambulatory, postmenopausal women who are diagnosised 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).

Please refer to this study by ClinicalTrials.gov identifier  NCT00148915

California
      GSK Clinical Trials Call Center, Upland,  California,  91786,  United States; Recruiting
Colorado
      GSK Clinical Trials Call Center, Lakewood,  Colorado,  80227,  United States; Recruiting
      GSK Clinical Trials Call Center, Boulder,  Colorado,  80304,  United States; Recruiting
Florida
      GSK Clinical Trials Call Center, Miami,  Florida,  33156,  United States; Recruiting
      GSK Clinical Trials Call Center, South Miami,  Florida,  33143,  United States; Recruiting
Georgia
      GSK Clinical Trials Call Center, Atlanta,  Georgia,  30308,  United States; Recruiting
      GSK Clinical Trials Call Center, Decatur,  Georgia,  30033,  United States; Recruiting
Indiana
      GSK Clinical Trials Call Center, Indianapolis,  Indiana,  46202,  United States; Recruiting
Maine
      GSK Clinical Trials Call Center, Bangor,  Maine,  04401,  United States; Not yet recruiting
Missouri
      GSK Clinical Trials Call Center, St. Louis,  Missouri,  63110,  United States; Not yet recruiting
New Mexico
      GSK Clinical Trials Call Center, Albuquerque,  New Mexico,  87106,  United States; Recruiting
New York
      GSK Clinical Trials Call Center, West Haverstraw,  New York,  10993,  United States; Not yet recruiting
Pennsylvania
      GSK Clinical Trials Call Center, Duncansville,  Pennsylvania,  16635,  United States; Recruiting

Study chairs or principal investigators

GSK Clinical Trials, MD,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  BON103593
Last Updated:  September 9, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00148915
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13