ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 46 of 170 for:    ovarian cancer and Minnesota

Zoledronic Acid in Preventing Osteoporosis in Patients Undergoing Donor Stem Cell Transplant

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: NCT00321932
Recruitment Status : Completed
First Posted : May 4, 2006
Results First Posted : October 26, 2012
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Myelodysplastic Syndromes
Osteoporosis
Ovarian Cancer
Interventions: Dietary Supplement: calcium
Dietary Supplement: cholecalciferol
Drug: zoledronic acid

  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 undergoing allogeneic hematopoietic stem cell transplantation (HCT) at participating institutions were offered this trial. If the patient met study requirements, the patient was registered and randomized.

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
Arm I (Standard of Care) Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
Arm II (Treatment With Zometa) Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.

Participant Flow:   Overall Study
    Arm I (Standard of Care)   Arm II (Treatment With Zometa)
STARTED   29   32 
COMPLETED   19   11 
NOT COMPLETED   10   21 
Death                3                6 
Withdrawal by Subject                3                6 
Early relapse                2                8 
Missing data                2                1 



  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
  Description
Arm I (Standard of Care) Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
Arm II (Treatment With Zometa) Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
Total Total of all reporting groups

Baseline Measures
   Arm I (Standard of Care)   Arm II (Treatment With Zometa)   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   32   61 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      29 100.0%      32 100.0%      61 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 51  (10)   51  (12)   51  (11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      13  44.8%      9  28.1%      22  36.1% 
Male      16  55.2%      23  71.9%      39  63.9% 
Region of Enrollment 
[Units: Participants]
     
United States   29   32   61 


  Outcome Measures

1.  Primary:   Mean Change in Bone Mineral Density   [ Time Frame: From Time of Transplant to 12 Months Post-Transplant ]

2.  Secondary:   Mean Change in Serum Osteocalcin   [ Time Frame: From Time of Transplant to 12 Months Post-Transplant ]

3.  Secondary:   Mean Change in Serum Bone Specific Alkaline Phosphate   [ Time Frame: From Time of Transplant to 12 Months Post-Transplant ]

4.  Secondary:   Mean Change in Urinary N-terminal Telopeptide   [ Time Frame: From Time of Transplant to 12 Months Post-Transplant ]

5.  Secondary:   Mean Change in Luteinizing Hormone   [ Time Frame: From Time of Transplant to 12 Months Post-Transplant ]

6.  Secondary:   Mean Change in Follicle-Stimulating Hormone   [ Time Frame: From Time of Transplant to 12 Months Post-Transplant ]

7.  Secondary:   Mean Change in Thyroid Function Test 4   [ Time Frame: From Time of Transplant to 12 Months Post-Transplant ]

8.  Secondary:   Mean Change in Ultrasensitive Estradiol   [ Time Frame: From Time of Transplant to 12 Months Post-Transplant ]

9.  Secondary:   Mean Change in Total Testosterone   [ Time Frame: From Time of Transplant to 12 Months Post-Transplant ]


  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
No text entered.


  More Information

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


Results Point of Contact:  
Name/Title: Linda Burns, M.D.
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-624-8144
e-mail: burns023@umn.edu



Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00321932     History of Changes
Other Study ID Numbers: 2005NT018
UMN-0506M70866 ( Other Identifier: IRB, University of Minnesota )
UMN-MT2005-06 ( Other Identifier: Blood and Marrow Transplantation Program )
NOVARTIS-CZOL446EUS29 ( Other Identifier: Novartis )
First Submitted: May 2, 2006
First Posted: May 4, 2006
Results First Submitted: May 4, 2012
Results First Posted: October 26, 2012
Last Update Posted: March 9, 2017