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Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer, Lung Cancer, or Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00365105
First received: August 16, 2006
Last updated: November 3, 2014
Last verified: November 2014
Results First Received: November 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Breast Cancer
Lung Cancer
Metastatic Cancer
Pain
Prostate Cancer
Interventions: Dietary Supplement: Calcium
Dietary Supplement: Vitamin D
Drug: zoledronic acid
Drug: Sm-153
Radiation: Sr-89

  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
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
Zoledronic Acid Zoledronic acid, vitamin D and calcium supplements.
Zoledronic Acid + Radopharmaceuticals Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.

Participant Flow:   Overall Study
    Zoledronic Acid     Zoledronic Acid + Radopharmaceuticals  
STARTED     129     132  
COMPLETED     123     128  
NOT COMPLETED     6     4  
Protocol Violation                 4                 3  
Withdrawal by Subject                 1                 1  
Lost to Follow-up                 1                 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.
Eligible patients

Reporting Groups
  Description
Zoledronic Acid Zoledronic acid, vitamin D and calcium supplements.
Zoledronic Acid + Radopharmaceuticals Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
Total Total of all reporting groups

Baseline Measures
    Zoledronic Acid     Zoledronic Acid + Radopharmaceuticals     Total  
Number of Participants  
[units: participants]
  124     129     253  
Age  
[units: years]
Median ( Full Range )
  68  
  ( 25 to 88 )  
  68  
  ( 32 to 90 )  
  68  
  ( 25 to 90 )  
Gender  
[units: participants]
     
Female     46     50     96  
Male     78     79     157  



  Outcome Measures

1.  Primary:   Time to Development of a Malignant Skeletal-related Events (SRE)   [ Time Frame: From randomization to date of SRE development ]

2.  Secondary:   SRE Rate at 1 Year   [ Time Frame: From randomization to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Overall Survival   [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs at the same time as the primary outcome. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Changes in Quality of Life as Measured by FACT-G   [ Time Frame: From pre-treatment to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Changes in Pain Control as Measured by Brief Pain Inventory (BPI)   [ Time Frame: From pre-treatment to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Utility and Cost Effectiveness of the Use of Radiopharmaceuticals and Bisphosphonates as Measured by the EuroQol-5 Dimension (EQ-5D)   [ Time Frame: From pre-treatment to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
This study stopped accrual early with 261 accrued out of 352 planned, due to a lower than expected rate of skeletal related events in the control arm.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Wendy Seiferheld
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org


Publications of Results:
Seider MJ, Shook S, Langer CJ, et al.: Randomized phase III trial to evaluate radiopharmaceuticals and zoledronic acid in the palliation of osteoblastic metastases from lung, breast, and prostate cancer: report of RTOG 0517. [Abstract] J Clin Oncol 30 (Suppl 15): A-TPS9150, 2012.


Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00365105     History of Changes
Other Study ID Numbers: RTOG 0517, CDR0000491233, NCI-2009-00727
Study First Received: August 16, 2006
Results First Received: November 3, 2014
Last Updated: November 3, 2014
Health Authority: United States: Federal Government