At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 110 enrolled
Drug / intervention
zoledronic acid (aclasta)drug
Likely dose
zoledronic acid (aclasta) 5mgfrom 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.
Multicenter, Open-labeled, Randomized Clinical Trial to Determine the Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head
In Brief
A Phase 3 clinical trial evaluating zoledronic acid (aclasta) for Avascular Necrosis of Femoral Head. Completed, enrolled 110 participants across 1 site.
Detailed Summary
The purpose of this study is to test the effect of zoledronic acid over 2 years in preventing early collapse and progression of joint dome depression (≥ 2 mm by X-ray) of the femoral head in patients with large (\> 30%: criteria according to Kim et al) nontraumatic osteonecrosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAvascular Necrosis of Femoral Head
CountriesSouth Korea
CollaboratorsNovartis Korea Ltd.
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedJul 2009
Primary CompletionJun 2012
TodayJul 2026
First PostedJul 15, 2009
Enrollment StartJul 1, 2009
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 17.0 years ago
Interventions
zoledronic acid (aclasta)drug
Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period