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. Author manuscript; available in PMC: 2009 Sep 1.
Published in final edited form as: Contemp Clin Trials. 2008 May 18;29(5):711–719. doi: 10.1016/j.cct.2008.05.002

Table 1.

Factors investigated

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

a

Bone age will not be done on patients older than 25 years.

b

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)