Salusky 2005.

Methods	Study titles Salusky 2005, Salusky 2005a and Salusky 2005b represent the same RCT. The study (Salusky 2005) presents the data comparing sevelamer with calcium carbonate (Comparison 7) irrespective of vitamin D preparation. Data reported on 29 patients of 42 allocated to study 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: 13/42 did not complete the study
Participants	Country: USA Setting: University teaching hospital CCPD, PTH > 400 pg/mL; bone histomorphometry of secondary hyperparathyroidism Number (randomised/analysed): treatment group 1 (21/14); treatment group 2 (21/15) Mean age ± SD (years): treatment group 1 (11 ± 5); treatment group 2 (15 ± 3) Sex (M/F): treatment group 1 (10/4); treatment group 2 (8/7) 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 for 8 months Doxercalciferol or calcitriol given 3 times/wk. 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 group 2 Sevelamer: initial dose extrapolated from previous calcium carbonate doses; then titrated to keep P at 4 to 6 mg/dL. Continued for 8 months Doxercalciferol or calcitriol given 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 Co‐interventions 1000 mg oral calcium in sevelamer group if Ca < 8.2 mg/dL
Outcomes	Outcomes for comparison between phosphate binders Primary outcome: Bone formation rate Other bone histomorphometric parameters Final levels of ALP, PTH Average P, Ca x P, Ca
Notes	Factorial analysis provided no evidence of treatment interaction between two sterols so comparisons reported for phosphate binders irrespective of D sterol given 2005 report included 42 allocated patients with data on 29 (14 receiving CaCO3 and 15 receiving sevelamer)
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. Bone histology performed by scientist, who was blinded to treatment group
Incomplete outcome data (attrition bias) All outcomes	High risk	13/42 (31%) 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