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

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

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.
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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%

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 ]

2.  Primary:

Bone Mineral Density in Male and Female ALL Survivors   [ Time Frame: Baseline ]

3.  Primary:

Bone Mineral Density by Race of ALL Survivors   [ Time Frame: Baseline ]

4.  Primary:

Bone Mineral Density by Age Group of ALL Survivors   [ Time Frame: Baseline ]

5.  Secondary:

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

6.  Secondary:

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

7.  Secondary:

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

8.  Secondary:

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

9.  Secondary:

Mean QCT Z-Score by Apa1 Vitamin D Receptor Genotype   [ Time Frame: At enrollment ]

10.  Secondary:

Mean QCT Z-Score by Bsm 1 Vitamin D Receptor Genotype   [ Time Frame: At enrollment ]

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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