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A Two Year Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Fracture Efficacy and Safety of Intravenous Zoledronic Acid 5 mg Annually for the Treatment of Osteoporosis in Men
This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.
Details
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1199 |
| Start date | 2006-12 |
| Completion | 2010-10 |
Conditions
- Male Osteoporosis
Interventions
- Zoledronic acid 5 mg iv
- Placebo
Primary outcomes
- Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months — 24 Months
Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height
Countries
Argentina, Australia, Austria, Belgium, Brazil, Czechia, Denmark, Finland, Germany, Hungary, Iceland, Italy, Norway, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom