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)
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
🇺🇸Wyomissing, Pennsylvania, 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
Scroll for more (15 remaining)Catalina Pointe Clinical Research Inc.🇺🇸Tucson, Arizona, United States