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. 2015 Nov 12;2015(11):CD008327. doi: 10.1002/14651858.CD008327.pub2

Greenbaum 2007.

Methods
  • Study design: parallel RCT

  • Time frame: 2001 to 2003

  • Follow‐up period: 12 weeks after 2 to 6 weeks washout

  • Loss to follow‐up: 17 did not complete study but included in analysis 0% (0/29)

Participants
  • Country: USA

  • Setting: national, multicentre

  • HD for at least 1 month; PTH ≥ 300 pg/mL; Ca ≤ 10.5 mg/L, Ca x P ≤ 70 after 2 to 6 weeks run‐in

  • Number (randomised/completed): treatment group (15/10); control group (14/2)

  • Mean age ± SD (years): treatment group (13.6 ± 4.76); control group (14.3 ± 4.15)

  • Sex (M/F): treatment group (13/2); control group (5/9)

  • Exclusion criteria: allergy to paricalcitol or other vitamin D; pregnant; nursing; other major illness; AKI in previous 3 months; partial parathyroidectomy in previous 12 months; aluminium binders in past 3 months or likely to need binders; poor compliance; drugs likely to affect bone metabolism

Interventions Treatment group
  • IV paricalcitol: (0.04 µg/kg if PTH ≤ 500, and 0.08 µg/kg if PTH ≥ 500) 3 times/week for 12 weeks

  • Dose altered according to Ca and P levels


Control group
  • IV placebo: 3 times/week for 12 weeks

  • Dose altered according to Ca and P levels


Co‐interventions
  • Phosphate binders through study; dialysate Ca maintained at 2.5 mmol/L or 3 mmol/L through study

Outcomes
  • Proportion with > 30% fall in PTH on 2 consecutive occasions

  • Mean change in PTH levels

  • Mean changes in serum Ca, phosphorus, Ca x P levels

Notes
  • Patients discontinued after 4 weeks if had 2 PTH levels > 700 pg/mL

  • 10 withdrawn from placebo and 4 from paricalcitol groups for increased PTH

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Central randomisation
Allocation concealment (selection bias) Low risk Central randomisation
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Placebo and active medication given IV after dialysis
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Placebo and active medication given IV after dialysis; Primary outcome was laboratory based
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 12 (41%) prematurely withdrawn (5 treatment; 10 placebo) but these patients included in evaluation of primary outcome
Selective reporting (reporting bias) Low risk All relevant laboratory outcomes are included
Other bias High risk Supported by Abbott Laboratories