At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,199 enrolled
Drug / intervention
Zoledronic acid 5 mg iv +1 moredrug
Likely dose
Zoledronic acid 5 mg ivfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Zoledronic acid 5 mg iv and Placebo for Male Osteoporosis. Completed, enrolled 1,199 participants across 128 sites in 23 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMale Osteoporosis
CountriesArgentina, Australia, Austria, Belgium, Brazil, Czechia, Denmark, Finland, Germany, Hungary, Iceland, Italy, Norway, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2006
First PostedFeb 2007
Primary CompletionOct 2010
TodayJul 2026
First PostedFeb 23, 2007
Enrollment StartDec 1, 2006
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 19.4 years ago
Interventions
Zoledronic acid 5 mg ivdrug
Zoledronic acid 5 mg iv given once a year.
Placebodrug
Placebo intravenous (i.v.) once a year