Zoledronate in Preventing Osteoporosis in Patients With Primary Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00301873
Recruitment Status : Completed
First Posted : March 13, 2006
Results First Posted : January 16, 2013
Last Update Posted : February 18, 2013
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Duke University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Brain Tumors
Central Nervous System(CNS)Malignancies
Intervention: Drug: IV Zometa

  Participant Flow

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
No text entered.

Reporting Groups
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

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

Baseline Measures
   IV Zometa 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   49 
>=65 years   10 
[Units: Years]
Mean (Standard Deviation)
 54.7  (9.4) 
[Units: Participants]
Female   21 
Male   38 
Anticonvulsant use 
[Units: Participants]
yes   54 
no   5 
Steroid use 
[Units: Participants]
yes   41 
no   18 

  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

  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.

  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: Mary Lou Affronti, RN, MSN, ANP, MHSc Senior Investigator
Organization: Duke Comprehensive Cancer Center
phone: 919-684-6239

Responsible Party: Duke University Identifier: NCT00301873     History of Changes
Other Study ID Numbers: Pro00010125
P50NS020023 ( U.S. NIH Grant/Contract )
First Submitted: March 9, 2006
First Posted: March 13, 2006
Results First Submitted: October 15, 2012
Results First Posted: January 16, 2013
Last Update Posted: February 18, 2013