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Using TRAP to Evaluate the Effect of Zometa on Bone Metastasis Due to Lung Cancer

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: NCT00265200
Recruitment Status : Terminated (funding discontinued by sponsor)
First Posted : December 14, 2005
Results First Posted : April 6, 2017
Last Update Posted : March 5, 2018
Sponsor:
Collaborators:
James Graham Brown Cancer Center
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Goetz Kloecker, James Graham Brown Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Carcinoma, Non-Small Cell Lung
Carcinoma, Small Cell Lung
Metastases
Intervention Drug: zoledronic acid
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zoledronic Acid
Hide Arm/Group Description 3.0-4.0 mg by IV (in the vein), once a month for 6 months
Period Title: Overall Study
Started 28
Completed 24
Not Completed 4
Arm/Group Title Zoledronic Acid
Hide Arm/Group Description 3.0-4.0 mg by IV (in the vein), once a month for 6 months
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
0
   0.0%
Between 18 and 65 years
22
  78.6%
>=65 years
6
  21.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
16
  57.1%
Male
12
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title Average Percent Change From Baseline in TRAP Levels at 2 Weeks
Hide Description Change was calculated as 100% (value at baseline minus value at 2 weeks)/value at baseline
Time Frame TRAP levels at Baseline and 2 weeks after first Zometa infusion
Hide Outcome Measure Data
Hide Analysis Population Description
13 of 28 total study participants could not be evaluated: 7 due to sample deterioration; 5 participant non-compliance; 1 withdrew.
Arm/Group Title Zoledronic Acid
Hide Arm/Group Description:
3.0-4.0 mg by IV (in the vein), once a month for 6 months
Overall Number of Participants Analyzed 15
Mean (Full Range)
Unit of Measure: Percent change
NTx
37.3
(37 to 38)
TRAP-5b
44.9
(44 to 45)
bALP
12.9
(12 to 13)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zoledronic Acid
Hide Arm/Group Description 3.0-4.0 mg by IV (in the vein), once a month for 6 months
All-Cause Mortality
Zoledronic Acid
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Zoledronic Acid
Affected / at Risk (%)
Total   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zoledronic Acid
Affected / at Risk (%)
Total   0/28 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Goetz H Kloecker, MD
Organization: James Graham Brown Cancer Center, University of Louisville
Phone: 502-562-4358
Responsible Party: Goetz Kloecker, James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00265200     History of Changes
Other Study ID Numbers: 565.04
BCC-LUN-04-002 ( Other Identifier: James Graham Brown Cancer Center Clinical Trials Office )
First Submitted: December 12, 2005
First Posted: December 14, 2005
Results First Submitted: April 8, 2013
Results First Posted: April 6, 2017
Last Update Posted: March 5, 2018