A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo
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
1 other identifier
interventional
100
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2005
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 27, 2016
CompletedFirst Posted
Study publicly available on registry
October 31, 2016
CompletedOctober 31, 2016
October 1, 2016
1.9 years
October 27, 2016
October 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 Year
Secondary Outcomes (1)
Relationship between biomarkers and changes in bone quality for one year.
1 Year
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (15)
GSK Investigational Site
Upland, California, 91786, United States
GSK Investigational Site
Boulder, Colorado, 80304, United States
GSK Investigational Site
Lakewood, Colorado, 80227, United States
GSK Investigational Site
Miami, Florida, 33143, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
West Palm Beach, Florida, 33407, United States
GSK Investigational Site
Atlanta, Georgia, 30308, United States
GSK Investigational Site
Decatur, Georgia, 30033, United States
GSK Investigational Site
Indianapolis, Indiana, 46202, United States
GSK Investigational Site
Bangor, Maine, 04401, United States
GSK Investigational Site
Bathesda, Maryland, 20817, United States
GSK Investigational Site
Flint, Michigan, 48532, United States
GSK Investigational Site
Albuquerque, New Mexico, 87106, United States
GSK Investigational Site
West Haverstraw, New York, 10993, United States
GSK Investigational Site
Duncansville, Pennsylvania, 16635, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2016
First Posted
October 31, 2016
Study Start
August 1, 2005
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
October 31, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.