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Zoledronic Acid in Aromatase Inhibitor Induced Musculoskeletal Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01194440
First received: August 31, 2010
Last updated: May 11, 2017
Last verified: May 2017
Results First Received: November 10, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Supportive Care
Conditions: Ductal Carcinoma in Situ
Estrogen Receptor-positive Breast Cancer
Progesterone Receptor-positive Breast Cancer
Stage I Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Interventions: Drug: letrozole
Drug: zoledronic acid

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From February 2011 to January 2013, 59 women signed consent, met eligibility criteria, and received study intervention on this clinical trial at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were not included after consent if eligibility criteria were not met (eg, lab values, performance status); an additional 4 subjects were consented but not included in the study population.

Reporting Groups
  Description
Arm I - IV Zoledronic Acid Prophylaxis

Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.

letrozole: Given orally

zoledronic acid: Given IV

laboratory biomarker analysis: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

mass spectrometry: Correlative studies

bone scan: Correlative studies

quality-of-life assessment: Ancillary studies

questionnaire administration: Ancillary studies

pharmacogenomic studies: Correlative studies

high performance liquid chromatography: Correlative studies


Participant Flow:   Overall Study
    Arm I - IV Zoledronic Acid Prophylaxis
STARTED   59 
COMPLETED   47 
NOT COMPLETED   12 
Adverse Event                9 
Withdrawal by Subject                2 
Lost to Follow-up                1 



  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
Arm I

Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.

letrozole: Given orally

zoledronic acid: Given IV

laboratory biomarker analysis: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

mass spectrometry: Correlative studies

bone scan: Correlative studies

quality-of-life assessment: Ancillary studies

questionnaire administration: Ancillary studies

pharmacogenomic studies: Correlative studies

high performance liquid chromatography: Correlative studies


Baseline Measures
   Arm I 
Overall Participants Analyzed 
[Units: Participants]
 59 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      46  78.0% 
>=65 years      13  22.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      59 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   59 


  Outcome Measures

1.  Primary:   Frequency of Women With Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)   [ Time Frame: 12 months ]

2.  Secondary:   Health Assessment Questionnaire Disability Index   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Visual Analog Scale   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Number of Patients Who Discontinue or Change Aromatase Inhibitory (AI) Therapy   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Vered Stearns
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
phone: 443-287-6489
e-mail: HopkinsBreastTrials@jhmi.edu



Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01194440     History of Changes
Other Study ID Numbers: J1022
SKCCC J1022 ( Other Identifier: SKCCC )
Study First Received: August 31, 2010
Results First Received: November 10, 2016
Last Updated: May 11, 2017