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. 2014 Dec 9;2014(12):CD006254. doi: 10.1002/14651858.CD006254.pub2

Lindberg 2005.

Methods

  • Study design: parallel RCT

  • Study duration: May 2002 to March 2003

  • Study follow‐up: 26 weeks
Participants

  • Country: multinational

  • Setting: multicentre (60 centres)

  • Age ≥18 years; mean of two plasma iPTH values ≥ 300 pg/mL; mean of two serum calcium values ≥ 8.4 mg/dL during the screening phase; treatment with HD, continuous ambulatory PD, or automated PD for at least 1 mo before beginning study medication; patients who were receiving vitamin D therapy must have been treated with a stable dose for at least 30 d before enrolment

  • Number: treatment group (294); control group (101)

  • Mean age ± SD (years): treatment group (51.8 ± 14.0); control group (53.5 ± 13.9)

  • Sex (M/F): treatment group (181/113); control group (64/37)

  • Exclusion criteria: an unstable medical condition; undergone parathyroidectomy; MI within 3 mo before the study began
Interventions Treatment group

  • Cinacalcet: 30 to 180 mg/d

  • Duration: 16 weeks titration, 10 weeks maintenance


Control group

  • Placebo


Co‐interventions

  • Treatment group: vitamin D (65%); phosphate binders (NS)

  • Control group: vitamin D (69%); phosphate binders (NS)
Outcomes

  • Mean iPTH level ≤ 250 pg/mL

  • Reduction in iPTH of at least 30% from baseline

  • Mean percentage changes from baseline for iPTH, serum calcium, phosphorous, and Ca x P

  • Mean iPTH ≤ 300 pg/mL or reductions in iPTH of a least 20%, 40%, or 50% from baseline

  • Ca x P < 55 mg²/dL²

  • Mean reduction in Ca x P of at least 5 or 10 mg²/dL²
Notes

  • ITT: yes

  • Funding: "This study was supported by Amgen Inc. Holly Brenza Zoog assisted in the preparation of the manuscript."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Programmatic algorithm
Allocation concealment (selection bias) Low risk Interactive voice‐response system
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk NS
Incomplete outcome data (attrition bias) 
 All outcomes High risk Loss to follow‐up 25.3% of patients
Selective reporting (reporting bias) High risk Not reported systematically (end of treatment calcium, phosphorous, PTH and adverse events)
Other bias High risk Sponsor on authorship