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Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head

NCT00939900 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2015-07-02

Study results available
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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.

Conditions

  • Avascular Necrosis of Femoral Head

Interventions

DRUG

zoledronic acid (aclasta)

Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period

Sponsors & Collaborators

  • Novartis Korea Ltd.

    collaborator INDUSTRY

  • Seoul National University Bundang Hospital

    lead OTHER

Principal Investigators

  • Kyung-Hoi Koo, professor · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00939900 on ClinicalTrials.gov