Zoledronate in Preventing Osteoporosis in Patients With Primary Malignant Glioma

This study has been completed.
Sponsor:
Collaborators:
Novartis
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00301873
First received: March 9, 2006
Last updated: February 13, 2013
Last verified: February 2013
Results First Received: October 15, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Brain Tumors
Osteoporosis
Central Nervous System(CNS)Malignancies
Intervention: Drug: IV Zometa

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were accrued between February 2006 and January 2008 within the clinic at Duke Comprehensive Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None.

Reporting Groups
  Description
IV Zometa Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.

Participant Flow:   Overall Study
    IV Zometa  
STARTED     59  
COMPLETED     59  
NOT COMPLETED     0  



  Baseline Characteristics
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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
IV Zometa Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.

Baseline Measures
    IV Zometa  
Number of Participants  
[units: participants]
  59  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     49  
>=65 years     10  
Age  
[units: years]
Mean ± Standard Deviation
  54.7  ± 9.4  
Gender  
[units: participants]
 
Female     21  
Male     38  
Anticonvulsant use  
[units: participants]
 
yes     54  
no     5  
Steroid use  
[units: participants]
 
yes     41  
no     18  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent of Patients With Change in Combined Bone Mass Density T-score <= -0.5.   [ Time Frame: 6 and 12 months ]

2.  Secondary:   Skeletal-related Complications   [ Time Frame: 1 year ]

3.  Secondary:   Mean Change in Bone Mass Density (BMD)   [ Time Frame: 6 & 12 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


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
Limitations include early pt termination leading to small numbers of subjects analyzed (eg no BMD study at 6 and/or 12 mos)secondary to the poor overall survival (eg median survival 3-9 mos)associated with recurrent glioblastoma multiforme(GBM) pts.  


Results Point of Contact:  
Name/Title: Mary Lou Affronti, RN, MSN, ANP, MHSc Senior Investigator
Organization: Duke Comprehensive Cancer Center
phone: 919-684-6239
e-mail: mary.affronti@duke.edu


No publications provided


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00301873     History of Changes
Other Study ID Numbers: Pro00010125, P50NS020023
Study First Received: March 9, 2006
Results First Received: October 15, 2012
Last Updated: February 13, 2013
Health Authority: United States: Federal Government