Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head (EZAPCOFH)

This study has been completed.
Sponsor:
Collaborator:
Novartis Korea Ltd.
Information provided by (Responsible Party):
Kyung-Hoi Koo, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00939900
First received: July 14, 2009
Last updated: June 7, 2015
Last verified: June 2015
Results First Received: May 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Avascular Necrosis of Femoral Head
Intervention: Drug: zoledronic acid (aclasta)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Aclasta

aclasta group

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

Control control group

Participant Flow:   Overall Study
    Aclasta     Control  
STARTED     55     55  
COMPLETED     53     48  
NOT COMPLETED     2     7  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aclasta

aclasta group

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

Control control group
Total Total of all reporting groups

Baseline Measures
    Aclasta     Control     Total  
Number of Participants  
[units: participants]
  55     55     110  
Age  
[units: years]
Mean (Standard Deviation)
  43.8  (11.8)     45.2  (11.6)     44.5  (11.5)  
Gender  
[units: participants]
     
Female     16     14     30  
Male     39     41     80  



  Outcome Measures

1.  Primary:   Number of Participants With Femoral Head Collapse Within 24 Months   [ Time Frame: Measurements were done at 6, 12, 24 months ]

2.  Secondary:   Collpase Rate of Femoral Head   [ Time Frame: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Change of HHS (Harris Hip Scores), WOMAC Score, SF-36   [ Time Frame: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Time to Collapse of Femoral Head   [ Time Frame: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Time to Total Arthroplasty or Joint Preserving Surgery   [ Time Frame: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Professor
Organization: SeoulNUBH
phone: 82317877194
e-mail: khkoo@snu.ac.kr



Responsible Party: Kyung-Hoi Koo, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00939900     History of Changes
Other Study ID Numbers: CZOL446HKR08T
Study First Received: July 14, 2009
Results First Received: May 18, 2015
Last Updated: June 7, 2015
Health Authority: United States: Food and Drug Administration
Korea: Food and Drug Administration