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The goal of this study is to determine the effectiveness and safety of an annual intravenous treatment of zoledronic acid for the treatment of osteoporosis in men. All patients will receive calcium and vitamin D supplements.
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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 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations |
| Measure | Description | Time Frame |
|---|---|---|
| To compare % change in Lumbar Spine BMD from Baseline to Months 6 and 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations | ||
| To compare % change in BMD at the Total Hip, Femoral Neck, Trochanter and Total Body, from Baseline to Months 6, 12 and 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations |
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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 |
|---|---|---|---|---|---|---|
| Catalina Pointe Clinical Research Inc. | Tucson | Arizona | 85704 | United States | ||
| Diablo Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21037195 | Derived | Grbic JT, Black DM, Lyles KW, Reid DM, Orwoll E, McClung M, Bucci-Rechtweg C, Su G. The incidence of osteonecrosis of the jaw in patients receiving 5 milligrams of zoledronic acid: data from the health outcomes and reduced incidence with zoledronic acid once yearly clinical trials program. J Am Dent Assoc. 2010 Nov;141(11):1365-70. doi: 10.14219/jada.archive.2010.0082. |
| Label | URL |
|---|---|
| For information regarding US facilities, click this hyperlink. | View source |
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| To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations at all study timepoints, relative to Baseline |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Colorado Center for Bone Research | Lakewood | Colorado | 80227 | United States |
| Radiant Research | Stuart | Florida | 34996 | United States |
| United Osteoporosis Center | Gainesville | Georgia | 30501 | United States |
| Northwestern Center for Clinical Research | Chicago | Illinois | 60611 | United States |
| Mercy Arthritis and Osteoporosis Center | Des Moines | Iowa | 50322 | United States |
| St. Joseph Hospital | Bangor | Maine | 04401 | United States |
| Osteoporosis and Clinical Trials Center | Hagerstown | Maryland | 21740 | United States |
| New Mexico Clinical Research and Osteoporosis Center | Albuquerque | New Mexico | 87106 | United States |
| Helen Hayes Hospital | West Haverstraw | New York | 10993 | United States |
| UC Bone Health and Osteoporosis Center | Cincinnati | Ohio | 45219 | United States |
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States |
| Radiant Research | Wyomissing | Pennsylvania | 19610 | United States |
| Hampton Roads Center for Clinical Research | Norfolk | Virginia | 23502 | United States |
| McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| Garvan Institute of Medical Research | Sydney | New South Wales | 2010 | Australia |
| Repatriation General Hospital | Daw Park | South Australia | 5041 | Australia |
| Keogh Institute for Medical Research | Nedlands | Western Australia | 6009 | Australia |
| Clinical Research Center | Vancouver | British Columbia | V5Z 2N6 | Canada |
| QEII HealthSciences Center | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Charlton Medical Building | Hamilton | Ontario | L8N 1Y2 | Canada |
| Centre De Recherche Clinique De Laval | Laval | Quebec | H7T 2P5 | Canada |
| Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada |
| Groupe de Recherche en Rhumatologie et Maladies Osseuses | Sainte-Foy | Quebec | G1V 3M7 | Canada |
| Saskatoon Osteoporosis Center | Saskatoon | Saskatchewan | S7K 0H6 | Canada |
| 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 |
|---|---|
| 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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