Table 1.
Baseline | 6 mo | 12 mo | 18 mo | 24 mo | 36 mo | |
---|---|---|---|---|---|---|
QCT* | ✓ | ✓ | ✓ | ✓ | ||
DXA | ✓ | ✓ | ✓ | ✓ | ||
Bone age (from hand or wrist) | ✓a | ✓b | ||||
Blood for: | ||||||
Bone-specific alkaline phosphatase | ✓ | ✓ | ✓ | ✓ | ✓ | |
Intact parathyroid hormone | ✓ | |||||
Osteocalcin | ✓ | ✓ | ✓ | ✓ | ✓ | |
Hemoglobin and hematocrit | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
25-hydroxyvitamin D | ✓ | |||||
Calcium and albumin | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Phosphorus | ✓ | ✓ | ✓ | ✓ | ||
Testosterone or estradiol | ✓ | ✓ | ✓ | ✓ | ||
Liver function enzymes | ✓ | ✓ | ✓ | ✓ | ||
Blood urea nitrogen and creatinine | ✓ | ✓ | ✓ | ✓ | ||
Free T4, T4, thyroid stimulating hormone | ✓ | ✓ | ||||
Ferritin | ✓ | ✓ | ✓ | ✓ | ||
β human chorionic gonadotropin | ✓ | ✓ | ✓ | ✓ | ||
3A4 receptor genotyping | ✓ | |||||
Urine for: | ||||||
Sodium | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Calcium:creatinine ratio | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
N-telopeptide | ✓ | ✓ | ✓ | ✓ | ✓ | |
Height and weight | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Tanner stage | ✓ | ✓ | ✓ | ✓ | ||
Dietary intake: | ||||||
Magnesium | ✓ | ✓ | ✓ | ✓ | ||
Potassium | ✓ | ✓ | ✓ | ✓ | ||
Calcium | ✓ | ✓ | ✓ | ✓ | ||
Protein | ✓ | ✓ | ✓ | ✓ | ||
Phosphorus | ✓ | ✓ | ✓ | ✓ |
Mo=months
QCT=quantitative computed tomography
DXA=dual-energy x-ray absorptiometry
Bone age will not be done on patients older than 25 years.
Bone age will be obtained at 24 months only if the patient is skeletally immature at enrollment.
QCT-determined BMD serves as an eligibility screen for participation in the interventional phase (Study 2)