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

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ClinicalTrials.gov Identifier: NCT00186901
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : March 27, 2012
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Leukemia, Lymphoblastic, Acute
Osteoporosis
Interventions: Drug: Calcium carbonate (Tums), vitamin D
Other: Placebo

  Participant Flow

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

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 
Overall Participants Analyzed 
[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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		       
Female      56  41.8%      63  44.7%      87  58.4%      206  48.6% 
Male      78  58.2%      78  55.3%      62  41.6%      218  51.4% 


  Outcome Measures

1.  Primary:   Effect of Taking Calcium and Vitamin D Supplements on Bone Mineral Density (BMD)   [ Time Frame: Baseline, 12 months, 24 months, and at 36 months or study end ]
  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:   Mean QCT Z-Score by Apa1 Vitamin D Receptor Genotype   [ Time Frame: At enrollment ]
  Show Outcome Measure 9

10.  Secondary:   Mean QCT Z-Score by Bsm 1 Vitamin D Receptor Genotype   [ Time Frame: At enrollment ]
  Show Outcome Measure 10


  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: Sue Kaste, DO
Organization: St. Jude Children's Research Hospital
phone: 866-278-5833
e-mail: referralinfo@stjude.org


Publications:


Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00186901     History of Changes
Other Study ID Numbers: BONEII
First Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: December 20, 2011
Results First Posted: March 27, 2012
Last Update Posted: May 10, 2017