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

Malluche 2008.

Methods

  • Study design: parallel RCT

  • Study duration: October 2001 to May 2003

  • Study follow‐up: 52 weeks
Participants

  • Country: multinational

  • Setting: multicentre (17 centres)

  • Medically stable patients ≥ 18 years who had received HD for ≥ 1 month with biochemical evidence of elevated PTH levels; albumin‐adjusted serum calcium concentration ≥ 8.4 mg/dL; either Hb level > 9.0 g/dL or a HCT value > 27%; patients receiving vitamin D sterols had to have been on a constant dose for ≥ 30 days before beginning the study

  • Number: treatment group (19); control group (13)

  • Mean age ± SD (years): treatment group (50.3 ± 13.3); control group (51.5 ± 14.1)

  • Sex (M/F): treatment group (12/7); control group (9/4)

  • Exclusion criteria: received bisphosphonate or fluoride during the preceding 90 days
Interventions Treatment group

  • Cinacalcet: 30 to 180 mg/d

  • Duration: 24 weeks titration, 28 weeks maintenance


Control group

  • Placebo


Co‐interventions

  • Treatment group: vitamin D (47%); phosphate binders (100%)

  • Control group: vitamin D (54%); phosphate binders (77%)
Outcomes

  • Interval changes in activation frequency, bone formation rate/bone surface, number of osteoblasts and osteoclasts/bone perimeter, fibrosis surface/bone surface and woven osteoid surface/bone surface

  • Absolute and percentage changes from baseline in iPTH, BSAP, NTx and Ca x P
Notes

  • ITT: no

  • Funding: "This study was supported by Amgen Inc (Study 20010141)"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated
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 31.3% of patients
Selective reporting (reporting bias) High risk Not reported systematically (end of treatment calcium, posphorous, PTH and adverse events)
Other bias High risk Sponsor authorship