| Primary | Effect of Taking Calcium and Vitamin D Supplements on Bone Mineral Density (BMD) | The effect of taking calcium and vitamin D supplements was measured using Quantitative Computed Tomography (QCT) to calculate a QTC Z score. A standardized Z-score was calculated to indicate the difference between the patient's Bone Mineral Density (BMD) and the mean value for age and gender-appropriate controls. Z-scores from 0 to +2 are considered normal, above +2 are considered to be elevated, from 0 to -1 are considered to represent a mild BMD deficit, between -1 and -2 are considered to represent moderate deficits, and below -2 are considered to represent severe deficits. | Of the 275 pts identified with BMD z-scores < 0, 134 were randomized to the placebo group and 141 to the supplement group. Bone Mineral Density QCT Z-scores were calculated at baseline, 12 months, 24 months, and at 36 months or study end. | Posted | | Median | Full Range | Z-Score | | Baseline, 12 months, 24 months, and at 36 months or study end | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo Group (Placebo Comparator 1A): Patients who received placebo pills. | | OG001 | Supplement | CVD Supplement Group (Experimental 1B): Patients who received calcium and vitamin D supplementation. |
| | | Title | Denominators | Categories |
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| Baseline | | | Title | Measurements |
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| - OG000-0.95(-3.09 to -0.05)
- OG001-0.97(-3.94 to -0.04)
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| | 12 Months | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Wilcoxon Test | | 0.86 | | Median Difference (Final Values) | -0.02 | | | | 95 | | | | | | | Superiority or Other | | | | 12 Month BMD Z-Score Calculation where N=109 | Wilcoxon Test |
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| Primary | Bone Mineral Density in Male and Female ALL Survivors | Using bone mineral density Z-score, assess relationship between predisposing factors (gender) and bone mineral density; a negative value indicates a deficit in bone mineral density. | Baseline participants were assessed to determine whether gender was a pre-disposing factor for bone mineral density. | Posted | | Median | Standard Error | Z-score | | Baseline | | | | ID | Title | Description |
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| OG000 | Male | 218 males were eligible for the study | | OG001 | Female | 206 females were eligible for the study |
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| Primary | Bone Mineral Density by Race of ALL Survivors | Using bone mineral density Z-score, assess relationship between predisposing factors (race) and bone mineral density; a negative value indicates a deficit in bone mineral density. | Assess baseline participants to determine whether race contributed to bone mineral density. | Posted | | Median | Standard Error | Z-score | | Baseline | | | | ID | Title | Description |
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| OG000 | White | 365 white patients were eligible for the study | | OG001 | Non-white | 59 non-white were eligible for the study |
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| Primary | Bone Mineral Density by Age Group of ALL Survivors | Using bone mineral density Z-score, assess relationship between predisposing factors (age groups) and bone mineral density; a negative value indicates a deficit in bone mineral density. | Assess baseline participants to determine whether age was a contributing factor in bone mineral density. | Posted | | Median | Standard Error | Z-score | | Baseline | | | | ID | Title | Description |
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| OG000 | 9 to 13 Years | 98 patients between the ages of 9 and 13 were eligible for the study | | OG001 | 13 to 18 Years | 139 patients between the ages of 13 and 18 were eligible for the study | | OG002 | 18 to 22 Years | 74 patients between the ages of 18 and 22 were eligible for the study | | OG003 | Above 22 Years | 113 patients greater than 22 years of age were eligible for the study |
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| Secondary | Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density. | To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 121 patients at baseline were assessed by both method the QCT and DXA methods to assess Bone Mineral Density. | 275 patients were assessed at baseline and received a QCT Scan. 121 patients were also assessed using the DEXA Scan. Comparison of the two methods used 121 paired studies to arrive at a correlation coefficient. | Posted | | Mean | Standard Deviation | Z-score | | Baseline | | | | ID | Title | Description |
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| OG000 | Placebo - (QCT) | 134 patients were assessed at baseline using the QCT scan. | | OG001 | Placebo - (DXA) | 60 of the 134 baseline patients also had a DXA scan. | | OG002 | Supplement - (QCT) | 141 patients were assessed at baseline using the QCT scan. | | OG003 | Supplement - (DXA) | |
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| Secondary | Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density. | To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 218 patients were assessed at 12 months for QCT. 94 were evaluated using DXA. 94 patients received both scans. | 218 patients were assessed at the 12 months interval and received a QCT Scan. 94 patients were also assessed using the DXA Scan. Comparison of the two methods used 94 paired studies to arrive at a correlation. | Posted | | Mean | Standard Deviation | Z-score | | 12 months | | | | ID | Title | Description |
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| OG000 | Placebo - (QCT) | 109 patients were assessed at 12 months using the QCT scan. | | OG001 | Placebo - (DXA) | 47 of the 109 patients assessed at 12 months also had a DXA scan. | | OG002 | Supplement - (QCT) | 109 patients were assessed at 12 months using the QCT scan. | | OG003 | Supplement - (DXA) | |
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| Secondary | Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density. | To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 188 patients were assessed at 24 months by the QCT method and 90 were evaluated using the DXA methods to assess Bone Mineral Density. 90 patients received both scans. | 188 patients were assessed at the 24 months interval and received a QCT Scan. 90 patients were also assessed using the DXA Scan. Comparison of the two methods used 90 paired studies to arrive at a correlation. | Posted | | Mean | Standard Deviation | Z-score | | 24 months | | | | ID | Title | Description |
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| OG000 | Placebo - (QCT) | 91 patients were assessed at 24 months using the QCT scan. | | OG001 | Placebo - (DXA) | 39 of the 91 patients assessed at 24 months also had a DXA scan. | | OG002 | Supplement - (QCT) | 97 patients were assessed at 24 months using the QCT scan. | | OG003 | Supplement - (DXA) |
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| Secondary | Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density. | To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 180 patients were assessed at 36 months by the QCT method and 89 were evaluated using the DXA methods to assess Bone Mineral Density. 89 patients received both scans. | 180 patients were assessed at the 36 months interval and received a QCT Scan. 89 patients were also assessed using the DEXA Scan. Comparison of the two methods produced 89 paired studies to arrive at a correlation. | Posted | | Median | Standard Deviation | Z-score | | 36 months | | | | ID | Title | Description |
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| OG000 | Placebo - (QCT) | 84 patients were assessed at 36 months using the QCT scan. | | OG001 | Placebo - (DXA) | 36 of the 84 patients assessed at 36 months also had a DXA scan. | | OG002 | Supplement - (QCT) | 96 patients were assessed at 36 months using the QCT scan. | | OG003 | Supplement - (DXA) |
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| Secondary | Mean QCT Z-Score by Apa1 Vitamin D Receptor Genotype | The Apa1 Vitamin D Receptor has been associated with bone mineral density and bone turnover markers in various patient cohorts but has not been investigated I survivors of childhood | Of the 424 patients screened, 417 participants consented for genetic testing. Of the 417 patients screened for the Apa 1 vitamin D receptor, only 68 had the AA genotype, 104 had the Aa genotype, and 49 had the aa genotype. | Posted | | Mean | Standard Deviation | QCT Z-Score | | At enrollment | | | | ID | Title | Description |
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| OG000 | Apa 1 - AA Genotype | The AA genotype was observed in 68 (16.31%) out of 417 participants, with a median BMD Z score (a unit-less measure comparing to the age and gender matched national average) of -0.56. | | OG001 | Apa 1 - Aa Genotype | The Aa genotype was observed in 104 (24.94%) out of 417 participants, with a median BMD Z score of -0.44. | | OG002 | Apa 1 - aa Genotype | The aa genotype was present in 49 (11.75%) out of 417 participants, with a median BMD Z score of -0.57. |
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| Secondary | Mean QCT Z-Score by Bsm 1 Vitamin D Receptor Genotype | The Bsm1 Vitamin D Receptor has been associated with bone mineral density and bone turnover markers in various patient cohorts but has not been investigated I survivors of childhood | Of the 424 patients screened, 417 participants consented for genetic testing. Of the 417 patients screened for the Bsm 1 vitamin D receptor, only 41 had the BB genotype, 65 had the Bb genotype, and 77 had the bb genotype. | Posted | | Mean | Standard Deviation | QCT Z-Score | | At enrollment | | | | ID | Title | Description |
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| OG000 | Bsm - BB Genotype | The BB genotype was observed in 41 (09.83%) out of 417 participants, with a median BMD Z score (a unit-less measure comparing to the age and gender matched national average) of -0.5. | | OG001 | Bsm - Bb Genotype | The Bb genotype was observed in 65 (15.59%) out of 417 participants, with a median BMD Z score of -0.17. | | OG002 | Bsm - bb Genotype | The bb genotype was observed in 77 (18.47%) out of 417 participants, with a median BMD Z score of -0.17. |
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