| Methods |
Study titles Salusky 2005, Salusky 2005a and Salusky 2005b represent the same RCT. The study title (Salusky 2005b) has been used to allow the presentation of data for vitamin D groups + calcium carbonate (treatment groups 1 and 3) Study design: parallel RCT: 2 x 2 longitudinal factorial study design Time frame: 2003 to 2005 Follow‐up period: 8 months Loss to follow‐up/excluded: 15%; 9/60 did not complete study; transplant (5), non‐compliance (4) |
| Participants |
Country: USA Setting: University teaching hospital CCPD, PTH > 400 pg/mL; bone histomorphometry of secondary hyperparathyroidism Number (randomised/analysed): treatment group 1 (16/11); treatment group 3 (16/15) Mean age ± SD (years): treatment group 1 (14.2 ± 3.6); treatment group 3 (12.0 ± 12) Sex (M/F): treatment group 1 (10/6); treatment group 3 (9/7) Exclusion criteria: previous history of poor compliance; parathyroidectomy in last 12 months; immunosuppressive agents; rhGH |
| Interventions |
Treatment group 1
CaCO3 titrated to keep P at 4 to 6 mg/dL Doxercalciferol: 3 times/week. Initial dose depended on PTH level, then titrated to keep PTH at 300 to 400 pg/mL and Ca 8.4 to 10.2 mg/dL Treatment duration: 8 months
Treatment group 3
CaCO3: titrated to keep P at 4 to 6 mg/d: Calcitriol: 3 times/week. Initial dose depended on PTH level, then titrated to keep PTH at 300 to 400 pg/mL and Ca 8.4 to 10.2 mg/dL Treatment duration: 8 months
Co‐interventions
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| Outcomes |
Outcomes for comparison between vitamin D preparations
Bone formation rate Other bone histomorphometric parameters Final levels of PTH, Ca, P, FGF 23
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| Notes |
Factorial analysis provided no evidence of treatment interaction between two sterols so comparisons reported for phosphate binders irrespective of D sterol given 2011 report included 60 allocated patients with data on 51 provided for 4 groups |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomised longitudinal factorial study. Computer generated randomisation |
| Allocation concealment (selection bias) |
Low risk |
Computer generated, allocated by statistician |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Participants, care givers, investigators not blinded to interventions |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Outcomes laboratory based and unlikely to be influenced by lack of blinding |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
9/60 (15%) did not complete study. Lack of data on these patients could have influenced results |
| Selective reporting (reporting bias) |
High risk |
Primary outcome was bone histology; secondary outcomes only reported graphically |
| Other bias |
Low risk |
USPH grants and Casey Lee Ball Foundation but Bone Care International provided medications and other unrestricted support for the study |
