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A Severity-Adapted Clinical Trial of Diminished Bone Mineral Density in Acute Lymphoblastic Leukemia Survivors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00186901
First received: September 12, 2005
Last updated: December 6, 2012
Last verified: December 2011
History of Changes
Results First Received: December 20, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Leukemia, Lymphoblastic, Acute
Osteoporosis
Interventions: Drug: Calcium carbonate (Tums), vitamin D
Other: Placebo

  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
429 patients were recruited at St. Jude Children's Research Hospital between August 7, 2000 and July 27, 2006. 4 patients were found to be ineligible and 1 patient was taken off study per the PI's request. 424 patients were available at baseline.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
424 total patients were enrolled on the study. 149 patients were ineligible for randomization. 275 patients were identified with Bone Mineral Density (BMD) Z-scores > 0 and thus were eligible for intervention and were randomized to receive either Calcium and Vitamin D supplementation or placebo.

Reporting Groups
  Description
Placebo Group Nutritional counseling + placebo
Supplement Group Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
Patients Ineligible for Randomization 424 patients were enrolled into the study, 149 were ineligible for randomization.

Participant Flow:   Overall Study
    Placebo Group     Supplement Group     Patients Ineligible for Randomization  
STARTED     134     141     149  
Baseline     134     141     0  
12 Month Follow-up     117     122     0  
24 Month Follow-up     106     107     0  
COMPLETED     85     96     0  
NOT COMPLETED     49     45     149  
Pregnancy                 6                 3                 0  
Lost to Follow-up                 6                 3                 0  
Bone Mineral Density dropped > 5%                 9                 7                 0  
ALL relapse or second malignancy                 1                 2                 0  
Withdrawal by Subject                 4                 5                 0  
Open label                 3                 2                 0  
Limited adherence to study requirements                 20                 23                 0  
Bone Mineral Density > 0                 0                 0                 149  



  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
Placebo Group Nutritional counseling + placebo
Supplement Group Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
Patients Ineligible for Randomization 424 patients were enrolled into the study, 149 were ineligible for randomization.
Total Total of all reporting groups

Baseline Measures
    Placebo Group     Supplement Group     Patients Ineligible for Randomization     Total  
Number of Participants  
[units: participants]
 		  134     141     149     424  
Age  
[units: years]
Mean (Standard Deviation) 		  17.9  (5.6)     17.6  (6.3)     19.2  (6.6)     17.8  (5.9)  
Gender  
[units: participants]
 		       
Female     56     63     87     206  
Male     78     78     62     218  



  Outcome Measures
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1.  Primary:   Effect of Taking Calcium and Vitamin D Supplements on Bone Mineral Density (BMD)   [ Time Frame: Baseline ]
  Show Outcome Measure 1

2.  Primary:   Bone Mineral Density in Male and Female ALL Survivors   [ Time Frame: Baseline ]
  Show Outcome Measure 2

3.  Primary:   Bone Mineral Density by Race of ALL Survivors   [ Time Frame: Baseline ]
  Show Outcome Measure 3

4.  Primary:   Bone Mineral Density by Age Group of ALL Survivors   [ Time Frame: Baseline ]
  Show Outcome Measure 4

5.  Secondary:   Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.   [ Time Frame: Baseline ]
  Show Outcome Measure 5

6.  Secondary:   Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.   [ Time Frame: 12 months ]
  Show Outcome Measure 6

7.  Secondary:   Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.   [ Time Frame: 24 months ]
  Show Outcome Measure 7

8.  Secondary:   Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.   [ Time Frame: 36 months ]
  Show Outcome Measure 8

9.  Secondary:   To Investigate Possible Risk Factors (Apa1 Vitamin D Receptor) for the Development of Diminished BMD in Patients Treated With Contemporary Protocol-based Therapy for Childhood ALL   [ Time Frame: At enrollment ]
  Show Outcome Measure 9

10.  Secondary:   To Investigate Possible Risk Factors (Bsm1 Vitamin D Receptor) for the Development of Diminished BMD in Patients Treated With Contemporary Protocol-based Therapy for Childhood ALL   [ Time Frame: At enrollment ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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  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
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  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: Sue Kaste, DO
Organization: St. Jude Children's Research Hospital
phone: 1-866-278-5833
e-mail: info@stjude.org


Publications:


Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00186901     History of Changes
Other Study ID Numbers: BONEII
Study First Received: September 12, 2005
Results First Received: December 20, 2011
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board