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The purpose of this study is to assess bone mineral density in patients switching from an oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zoledronic acid | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To compare % change in Lumbar Spine BMD from Baseline to Month 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic post-menopausal women populations |
| Measure | Description | Time Frame |
|---|---|---|
| To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations | ||
| To demonstrate continued bone remodeling by evaluation of bone biopsies in a subset of patients |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Permanente Medical Group | Santa Rosa | California | 95403 | United States | ||
| Colorado Center for Bone Research |
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| To assess patient preferences for annual i.v. therapy compared to weekly oral therapy through a patient questionnaire |
| Lakewood |
| Colorado |
| 80227 |
| United States |
| Florida Medical Research Institute | Gainsville | Florida | 32605 | United States |
| Radiant Research | Stuart | Florida | 34996 | United States |
| University of Kansas School of Medicine/ Division of Endocrinology | Kansas City | Kansas | 66160 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01610 | United States |
| Arthritis Center of Nebraska | Lincoln | Nebraska | 68516 | United States |
| Creighton University Osteoporosis Research Center | Omaha | Nebraska | 68131 | United States |
| Oregon Osteoporosis Center | Portland | Oregon | 97213 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Radiant Research | Wyomissing | Pennsylvania | 19610 | United States |
| Puget Sound Osteoporosis Center | Seattle | Washington | 98144 | United States |
| Novartis | Nuremberg | Germany |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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