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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibandronate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between biomarkers and changes in bone quality for one year. | 1 Year |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Upland | California | 91786 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| BON103593 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| 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 |
For additional information about this study please refer to the GSK Clinical Study Register |
| BON103593 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BON103593 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BON103593 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BON103593 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BON103593 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BON103593 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077557 | Ibandronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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