Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men
- Conditions
- Osteoporosis
- Registration Number
- NCT00097825
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 288
- Male, 25-85 years old
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations at all study timepoints, relative to Baseline
Trial Locations
- Locations (25)
St. Joseph Hospital
🇺🇸Bangor, Maine, United States
Osteoporosis and Clinical Trials Center
🇺🇸Hagerstown, Maryland, United States
UC Bone Health and Osteoporosis Center
🇺🇸Cincinnati, Ohio, United States
Garvan Institute of Medical Research
🇦🇺Sydney, New South Wales, Australia
Keogh Institute for Medical Research
🇦🇺Nedlands, Western Australia, Australia
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
United Osteoporosis Center
🇺🇸Gainesville, Georgia, United States
Colorado Center for Bone Research
🇺🇸Lakewood, Colorado, United States
Repatriation General Hospital
🇦🇺Daw Park, South Australia, Australia
Clinical Research Center
🇨🇦Vancouver, British Columbia, Canada
Mercy Arthritis and Osteoporosis Center
🇺🇸Des Moines, Iowa, United States
Catalina Pointe Clinical Research Inc.
🇺🇸Tucson, Arizona, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Northwestern Center for Clinical Research
🇺🇸Chicago, Illinois, United States
New Mexico Clinical Research and Osteoporosis Center
🇺🇸Albuquerque, New Mexico, United States
Hampton Roads Center for Clinical Research
🇺🇸Norfolk, Virginia, United States
Helen Hayes Hospital
🇺🇸West Haverstraw, New York, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
Charlton Medical Building
🇨🇦Hamilton, Ontario, Canada
QEII HealthSciences Center
🇨🇦Halifax, Nova Scotia, Canada
Groupe de Recherche en Rhumatologie et Maladies Osseuses
🇨🇦Sainte-Foy, Quebec, Canada
Centre De Recherche Clinique De Laval
🇨🇦Laval, Quebec, Canada
Saskatoon Osteoporosis Center
🇨🇦Saskatoon, Saskatchewan, Canada
Radiant Research
🇺🇸Wyomissing, Pennsylvania, United States