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The purpose of this randomized, double-blind, placebo-controlled study is to estimate the effect of oral ibandronate sodium (Boniva) taken once monthly versus placebo on bone quality and strength at the proximal femur at one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibandronate | Experimental | Participants will receive 150 milligrams (mg) ibandronate tablet orally once monthly for one year. |
|
| Placebo | Placebo Comparator | Participants will receive ibandronate matched placebo tablet orally once monthly for one year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibandronate | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean percent change in integral (cortical and trabecular bone compartments combined) hip bone mineral density (BMD) as determined by Volumetric Quantitative Computed Tomography (vQCT) at one year | Year 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean percent change in BMD of the proximal femur and lumbar spine according to vQCT at one year | Year 1 | |
| Mean percent change of proximal femur and spine BMD according to Dual- Energy X-ray Absorptiometry (DXA) scans | Year 1 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HoffmannLaRoche Clinical Trials, MD | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Upland | California | 91786 | United States | ||
| GSK Investigational Site |
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| Drug |
matching placebo |
|
| Hip geometry assessed by cross-sectional dimensions of hip using vQCT | Year 1 |
| Finite element composition of hip and spine to estimate hip and spine strength | Year 1 |
| Hip geometry assessed by cross-sectional dimensions of hip using DXA | Year 1 |
| Trabecular bone dimensions by bone biopsies using histomorphometry and micro computed tomography to assess bone quality | Year 1 |
| Change from baseline for serum-C-terminal cross-linking telopeptide of Type I collagen (Serum-CTX) | Months 3, 6, 9, and 12 |
| Change from baseline for bone-specific alkaline phosphatase (Bone ALP) | Months 3, 6, 9, and 12 |
| 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 | 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 |
| 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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