Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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.
 
ClinicalTrials.gov Identifier: NCT00301873
Recruitment Status : Completed
First Posted : March 13, 2006
Results First Posted : January 16, 2013
Last Update Posted : February 18, 2013
Sponsor:
Collaborators:
Novartis
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
Osteoporosis
Central Nervous System(CNS)Malignancies
Intervention Drug: IV Zometa
Enrollment 60
Recruitment Details Patients were accrued between February 2006 and January 2008 within the clinic at Duke Comprehensive Cancer Center.
Pre-assignment Details  
Arm/Group Title IV Zometa
Hide Arm/Group Description Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
Period Title: Overall Study
Started 59
Completed 59
Not Completed 0
Arm/Group Title IV Zometa
Hide Arm/Group Description Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
Overall Number of Baseline Participants 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
<=18 years
0
   0.0%
Between 18 and 65 years
49
  83.1%
>=65 years
10
  16.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants
54.7  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Female
21
  35.6%
Male
38
  64.4%
Anticonvulsant use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants
yes 54
no 5
Steroid use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants
yes 41
no 18
1.Primary Outcome
Title Percent of Patients With Change in Combined Bone Mass Density T-score <= -0.5.
Hide Description Percent of patients who failed treatment as defined by a decrease of 0.5 or more from baseline in the combined T-score as measured by Dexa-scan. The patient's bone densitometry was determined by Dexa-scan at baseline, after 6 months of Zometa and after 1 year of Zometa. The t-score, which is a comparison of a person's bone density with that of a healthy 30-year-old of the same sex, was generated by Dexa-scan for the spine and femur. The combined T-score is the minimum of the T-score for the spine and femur. A lower t-score implies a lower BMD.
Time Frame 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
59 patients were accrued; however only 27 had a follow-up assessment at 6 months and 19 at 12 months.
Arm/Group Title IV Zometa
Hide Arm/Group Description:
Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: percentage of patients
At 6 months (n=27) 3.7
At 12 months (n=19) 10.5
2.Secondary Outcome
Title Skeletal-related Complications
Hide Description Number of patients who experience skeletal-related complications during the administration of Zoledronate.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All patients.
Arm/Group Title IV Zometa
Hide Arm/Group Description:
Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: participants
0
3.Secondary Outcome
Title Mean Change in Bone Mass Density (BMD)
Hide Description Mean change in the combined t-score was measured by Dexa-scan. The patients bone density was determined by Dexa-scan at baseline, after 6 months Zometa and after 12 months of Zometa. The t-score, which is a comparison of a person's bone density with that of a healthy 30-year old of the same sex, was generated by Dexa-scan for the spine and femur. A lower t-score implies a lower BMD. The combined t-score is the minimum of the t-score for the spine and that for the femur. BMD change from baseline at 6 and 12 months in the combined t-score was defined as the follow-up combined t-score minus the baseline combined t-score.
Time Frame 6 & 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
59 patients were accrued to the study; however follow-up at 6 months was available from 27 patients and at 12 months data was available from 19 patients.
Arm/Group Title IV Zometa
Hide Arm/Group Description:
Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: T score units
Change in combined BMD at 6 months (n=27) .01  (.21)
Change in combined BMD at 12 months (n=19) -.06  (.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Zometa
Comments 59 patients were accrued to the study. The 27 patients with follow-up at 6 months are included in an analysis to assess the association between baseline steroid use and bone mass density at 6 months using linear regression.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .2212
Comments The p-value is a test of whether the slope of the regression line is non-zero.
Method Regression, Linear
Comments The linear regression assesses the relationship between baseline baseline steroid use and BMD change at 6 months (outcome).
Method of Estimation Estimation Parameter Slope
Estimated Value -.107
Parameter Dispersion
Type: Standard Error of the mean
Value: .0855
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IV Zometa
Comments 59 patients were accrued to the study. The 27 patients with follow-up at 6 months are included in an analysis to assess the association between baseline anticonvulsant use and bone mass density at 6 months using linear regression
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0413
Comments this p-value is at test of whether the slope of the regression line is non-zero.
Method Regression, Linear
Comments The linear regression assesses the relationship between anticonvulsant use and BMD change at 6 months (outcome).
Method of Estimation Estimation Parameter Slope
Estimated Value .2357
Parameter Dispersion
Type: Standard Error of the mean
Value: .1091
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection IV Zometa
Comments 59 patients were accrued to the study. The 19 patients with follow-up at 12 months are included in an analysis to assess the association between baseline steroid use and bone mass density at 12 months using linear regression
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0418
Comments this p-value is at test of whether the slope of the regression line is non-zero.
Method Regression, Linear
Comments The linear regression assesses the relationship between baseline steroid use and BMD change at 12 months (outcome).
Method of Estimation Estimation Parameter Slope
Estimated Value -.232
Parameter Dispersion
Type: Standard Error of the mean
Value: .1029
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection IV Zometa
Comments 59 patients were accrued to the study. The 19 patients with follow-up at 12 months are included in an analysis to assess the association between baseline anti-convulsant use and bone mass density at 12 months using linear regression
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .1026
Comments the p-value is a test of whether the slope ofl the regression line is non-zero.
Method Regression, Linear
Comments The linear regression assesses the relationship between anticonvulsant use and BMD change at 12 months.
Method of Estimation Estimation Parameter Slope
Estimated Value .2123
Parameter Dispersion
Type: Standard Error of the mean
Value: .1209
Estimation Comments [Not Specified]
Time Frame All Adverse Events regardless of grade over a period of 1 year
Adverse Event Reporting Description Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
 
Arm/Group Title IV Zometa
Hide Arm/Group Description Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
All-Cause Mortality
IV Zometa
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
IV Zometa
Affected / at Risk (%)
Total   16/59 (27.12%) 
Gastrointestinal disorders   
diarrhea  1  2/59 (3.39%) 
General disorders   
fever  1  5/59 (8.47%) 
Infections and infestations   
infections and infestations-other  1  3/59 (5.08%) 
Skin infection  1  2/59 (3.39%) 
Urinary tract infection  1  1/59 (1.69%) 
Device related infection  1  1/59 (1.69%) 
Injury, poisoning and procedural complications   
Vascular access complication  1  2/59 (3.39%) 
Investigations   
Neutrophil count decreased  1  1/59 (1.69%) 
Metabolism and nutrition disorders   
dehydration  1  1/59 (1.69%) 
Musculoskeletal and connective tissue disorders   
Generalized muscle weakness  1  1/59 (1.69%) 
Nervous system disorders   
Intracranial hemorrhage  1  1/59 (1.69%) 
Peripheral motor neuropathy  1  1/59 (1.69%) 
Facial nerve disorder  1  1/59 (1.69%) 
seizure  1  4/59 (6.78%) 
Depressed level of consciousness  1  3/59 (5.08%) 
headache  1  3/59 (5.08%) 
Skin and subcutaneous tissue disorders   
Skin ulceration  1  1/59 (1.69%) 
Vascular disorders   
phlebitis  1  1/59 (1.69%) 
thrombo embolic event  1  3/59 (5.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IV Zometa
Affected / at Risk (%)
Total   31/59 (52.54%) 
Eye disorders   
blurred vision  1  3/59 (5.08%) 
Gastrointestinal disorders   
constipation  1  8/59 (13.56%) 
diarrhea  1  5/59 (8.47%) 
General disorders   
fatigue  1  14/59 (23.73%) 
fever  1  3/59 (5.08%) 
Metabolism and nutrition disorders   
anorexia  1  4/59 (6.78%) 
Musculoskeletal and connective tissue disorders   
Generalized muscle weakness  1  7/59 (11.86%) 
arthralgia  1  5/59 (8.47%) 
Nervous system disorders   
ataxia  1  5/59 (8.47%) 
cognitive disturbance  1  6/59 (10.17%) 
dizziness  1  5/59 (8.47%) 
memory impairment  1  11/59 (18.64%) 
Peripheral motor neuropathy  1  8/59 (13.56%) 
Peripheral sensory neuropathy  1  4/59 (6.78%) 
seizure  1  3/59 (5.08%) 
Depressed level of consciousness  1  5/59 (8.47%) 
dysphasia  1  8/59 (13.56%) 
headache  1  9/59 (15.25%) 
Psychiatric disorders   
insomnia  1  7/59 (11.86%) 
confusion  1  10/59 (16.95%) 
mood alteration  1  3/59 (5.08%) 
Renal and urinary disorders   
urinary incontinence  1  4/59 (6.78%) 
erectile dysfunction  1  7/59 (11.86%) 
Skin and subcutaneous tissue disorders   
rash maculo-papular  1  3/59 (5.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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.
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
Layout table for Results Point of Contact information
Name/Title: Mary Lou Affronti, RN, MSN, ANP, MHSc Senior Investigator
Organization: Duke Comprehensive Cancer Center
Phone: 919-684-6239
EMail: mary.affronti@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00301873    
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