Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men

Completed · Phase 3

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT00097825

Run by

Novartis Pharmaceuticals

People needed

288

Starts

2004-04-01

Expected to finish

2007-08-01

Last updated by the study team

2012-04-27

Who can join

Age: 25 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male, 25-85 years old

You may not qualify if…

• Current users of bisphosphonates such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel ® (residronate), Skelid® (tiludronate)
• History of severe liver, kidney or eye disease
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Catalina Pointe Clinical Research Inc. — Tucson, Arizona, United States
• Diablo Clinical Research — Walnut Creek, California, United States
• Colorado Center for Bone Research — Lakewood, Colorado, United States
• Radiant Research — Stuart, Florida, United States
• United Osteoporosis Center — Gainesville, Georgia, United States
• Northwestern Center for Clinical Research — Chicago, Illinois, United States
• Mercy Arthritis and Osteoporosis Center — Des Moines, Iowa, United States
• St. Joseph Hospital — Bangor, Maine, United States
• Osteoporosis and Clinical Trials Center — Hagerstown, Maryland, United States
• New Mexico Clinical Research and Osteoporosis Center — Albuquerque, New Mexico, United States
• Helen Hayes Hospital — West Haverstraw, New York, United States
• UC Bone Health and Osteoporosis Center — Cincinnati, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Radiant Research — Wyomissing, Pennsylvania, United States
• Hampton Roads Center for Clinical Research — Norfolk, Virginia, United States
• McGuire VA Medical Center — Richmond, Virginia, United States
• Garvan Institute of Medical Research — Sydney, New South Wales, Australia
• Repatriation General Hospital — Daw Park, South Australia, Australia
• Keogh Institute for Medical Research — Nedlands, Western Australia, Australia
• Clinical Research Center — Vancouver, British Columbia, Canada
• QEII HealthSciences Center — Halifax, Nova Scotia, Canada
• Charlton Medical Building — Hamilton, Ontario, Canada
• Centre De Recherche Clinique De Laval — Laval, Quebec, Canada
• Royal Victoria Hospital — Montreal, Quebec, Canada
• Groupe de Recherche en Rhumatologie et Maladies Osseuses — Sainte-Foy, Quebec, Canada

Full record on ClinicalTrials.gov

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