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The purpose of this trial is to study the clinical safety, tolerability, and efficacy of zoledronic acid compared to an oral bisphosphonate in postmenopausal women with osteoporosis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zoledronic acid | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the rapidity of onset of action on bone turnover by comparing the percent change from baseline in urine N-telopeptide (NTx) in post-menopausal women |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect on markers of bone turnover by comparing the percent change from baseline in serum C-telopeptide (CTx) and urine NTx in post-menopausal women | ||
| To assess the frequency, intensity, and "bothersomeness" of dyspepsia, as measured by the Nepean Dyspepsia Index - Short Form, Symptom Checklist |
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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 |
|---|---|---|---|---|---|---|
| Univ. of Alabama/Division of Clinical Immunology and Rheumatology | Birmingham | Alabama | 35294 | United States | ||
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| To assess patient preferences for annual i.v. therapy compared to weekly oral therapy |
| Radiant Research |
| San Diego |
| California |
| 92108 |
| United States |
| Denver Arthritis Clinic | Denver | Colorado | 80230 | United States |
| Florida Medical Research Institute | Gainesville | Florida | 32605 | United States |
| Northwestern Center for Clinical Research | Chicago | Illinois | 60611 | United States |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | United States |
| Midwest Arthritis Center | Kalamazoo | Michigan | 49048-1634 | United States |
| St. John's Medical Research | Springfield | Missouri | 65807 | United States |
| Deaconess Billings Clinic Research Division | Billings | Montana | 59101 | United States |
| UMDNJ-Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
| Helen Hayes Hospital - Regional Bone Clinic | West Haverstraw | New York | 10993 | United States |
| Private Practice | Mayfield Village | Ohio | 44143 | United States |
| The Arthritis Clinic of Jackson | Jackson | Tennessee | 38305 | United States |
| Radiant Research | Dallas | Texas | 75235 | United States |
| Univ. of North Texas Health Science Center at Fort Worth | Fort Worth | Texas | 76107 | United States |
| St. Luke's Episcopal Hospital Ctr for Ortho. Res. and Education | Houston | Texas | 77030 | United States |
| Women's Health Center | Salt Lake City | Utah | 84117 | United States |
| Valley Medical Associates | Lewisburg | West Virginia | 24901 | United States |
| 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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