EZAPCOFH
Multicenter, Open-labeled, Randomized Clinical Trial to Determine the Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head
Sponsor study identifier
interventional
110
1 country
1
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2012
Actual (reported)Study Completion
June 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
July 14, 2009
Actual (reported)July 15, 2009
Actual (reported)June 2012
Actual (reported)June 2012
Actual (reported)July 2, 2015
Actual (reported)Number of Participants With Femoral Head Collapse Within 24 Months
Measurements were done at 6, 12, 24 months
Collpase Rate of Femoral Head
Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)
Change of HHS (Harris Hip Scores), WOMAC Score, SF-36
Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)
Time to Collapse of Femoral Head
Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)
Time to Total Arthroplasty or Joint Preserving Surgery
Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)
aclasta group
control group
Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Seoul national University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Kyung-Hoi Koo, professor
Seoul National University Bundang Hospital
110 participants (actual enrollment reported by the registry).
First Submitted
July 14, 2009
First Posted
July 15, 2009
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
June 2012
Actual (reported)Study Completion
June 2012
Actual (reported)Last Updated
July 2, 2015
Results First Posted
July 2, 2015
Record last verified: 2015-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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